MLリソース:生物兵器



●個々のワクチン等薬剤と感染菌については、末尾に移動しました。[2003.2.20]
[1147] 天然痘ワクチンsmallpox vaccine(Dryvax[Wyeth]) 
[1116-17] 炭疽菌治療薬ciproflaxacin (Cipro [Bayer])
[1116-17] 炭疽菌ワクチンanthrax vaccine (Biothrax [BioPort Corp]) 
他の炭疽菌治療薬
炭疸菌 Anthrax
ペスト plague
野兎病 tularemia
ブルセラ Brucellosis

●総説等[追加]
炭疽菌感染症〜私どもの経験を中心にして〜[感染症学誌76(1),2002]
炭疽菌芽胞に対する各種殺菌剤の有効性[感染症学誌76(4),2002]





■個別製品

[1494]●炭疽に対する沈降炭疽病ワクチンAnthrax Vaccine Adsorbed(BioThrax[Emergent BioDefense Operations Lansing LLC])

 日本語版註)炭疽に対する沈降炭疽病ワクチンAnthrax Vaccine Adsorbed(BioThrax[Emergent BioDefense Operations Lansing LLC])
 【別名】 【開発元】BioPort Corpは1998年創立→2004年Emergent BioSolutions Incに社名変更(子会社Emergent BioDefense Operations Lansing LLC)  [DBR_ID]
 【化学名】BioThrax (Anthrax Vaccine Adsorbed) is a sterile, milky-white suspension for intramuscular or subcutaneous injections made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. The production cultures are grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins, inorganic salts, and sugars. The final product, prepared from the sterile filtrate culture fluid contains proteins, including the 83kDa protective antigen (PA) protein, released during the growth period and contains no dead or live bacteria. The final product is formulated to contain 1.2 mg/mL aluminum, added as aluminum hydroxide in 0.85% sodium chloride. The final product is formulated to contain 25 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde, added as preservatives.
 【承認〜保管期限18ヵ月】FDA承認=31-Jan-2002、米国発売(BioThraxは、1970年に炭疽菌の暴露に高度なリスクを持つ者に対する予防ワクチンとして承認されている。) to Bioport Corporation;
 【承認〜保管期限36ヵ月】FDA承認=27-Apr-2005;to BioPort Corporation
 【承認〜皮下注→筋注;間隔0,2,4週&6,12,18ヵ月→0,4週&6,12,18ヵ月】FDA承認=11-Nov-2008;
 【承認〜投与スケジュール5回0,1,6,12,18ヵ月with annual booster→3回0,1,6ヵ月with boostersその後12,18ヵ月、それからannual boosters】FDA承認=17-May-2012;to Emergent BioDefense Operations Lansing Inc.
 【承認〜Bacillus anthracis exposureを含める】FDA承認=23-Nov-2015;
 【製剤】BioThrax is supplied in 5 mL multidose vials containing ten 0.5 mL doses of Anthrax Vaccine Adsorbed.  【適応】(18〜65歳の炭疽菌の暴露が疑われる者もしくは暴露が確定した者の炭疽病予防) For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.
BioThrax is approved for:
1. Pre-exposure prophylaxis of disease in persons at high risk of exposure.
2. Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. 【用法用量】筋注または皮下注、各0.5ml。 暴露前予防には、Primary Seriesとして0,1,6ヵ月目に筋注。 Booster SeriesではPrimary Series完了後12ヵ月間隔後に6,12ヵ月目に筋注。
暴露後予防には、Primary Seriesとして0,2,4週目に抗菌剤と共に皮下注。
 【作用】Anthrax is a zoonotic disease caused by the Gram-positive, spore-forming bacterium Bacillus anthracis. BioThrax induces antibodies raised against PA that may contribute to protection by neutralizing the activities of the cytotoxic lethal toxin and edema toxin of Bacillus anthracis.3 Bacillus anthracis proteins other than PA may be present in BioThrax, but their contribution to protection has not been determined. 【特徴】 
 【製品情報】www.biothrax.com 【添付文書】BioThrax-pi
 【提携】 【EU】 
 【日本】未開発 【その他】BioThrax売上2016年は$237M



[1494]●吸入炭疽病治療薬炭疽病免疫グロブリンAnthrax Immune Globulin Intravenous (Human)(Anthrasil[Emergent BioSolutions Inc])

 日本語版註)吸入炭疽病治療薬炭疽病免疫グロブリンAnthrax Immune Globulin Intravenous (Human)(Anthrasil[Emergent BioSolutions Inc])
 【別名】 【開発元】創製Cangene Corporation[加]2014年2月Emergent BioSolutions Incに買収  [DBR_ID]
 【化学名】ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax (Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method. The source plasma is tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 International Units of B19 DNA per mL.
 【承認】FDA承認=24-Mar-2015、米国発売 ;
 【製剤】Each vial of ANTHRASIL contains a minimum potency of ≧60 units per vial. ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative.
 【適応】(吸入炭疽病治療) Indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs 【用法用量】17歳以上の成人には7バイアル(420単位)。初回30分で0.5ml/分静注。 次回30分で1ml/分静注。 最大2ml/分静注。 小児1-16歳には1-7 vials (60-420単位)。初回30分で0.01ml/kg/分静注。 次回30分で0.02ml/kg/分静注。 最大0.04ml/kg/分静注。
 【作用】The polyclonal immune globulin G in ANTHRASIL is a passive immunizing agent that neutralizes anthrax toxin. ANTHRASIL binds to protective antigen (PA) to prevent PA mediated cellular entry of anthrax edema factor and lethal factor. ANTHRASIL is administered in combination with appropriate antibiotic therapy as the product itself is not known to have direct antibacterial activity against anthrax bacteria, which otherwise may continue to grow and product anthrax toxins. 【特徴】 
 【臨床成績】同剤の有効性は、ヒトでの臨床試験は倫理的に困難なため、動物試験(ウサギおよびサル)においてプラセボ対照比較試験が実施された。Anthrasil投与群でプラセボ群との比較、Anthrasilおよび抗生物質との併用群と抗生物質単剤投与群との比較で、Anthrasil投与群ではいずれも生存率を延長させたことが示された。この動物試験の結果により、同剤は、吸入炭疽病患者にもベネフィットがあると考えるのは合理的とされた。 
 【副作用】安全性は、74例の健常人で検証された。主な副作用は、頭痛、背痛、悪心、注射部位疼痛および腫脹など。 
 【添付文書】Anthrasil-pi
 【提携】 【EU】 
 【日本】未開発 【その他】Anthrasilは吸入炭疽による毒血症治療薬としてFDA承認された唯一のポリクロナル抗体だが、炭疽治療薬のモノクロナル抗体ラキシバクマブRaxibacumab(ABthrax[GSK])もFDA承認を受けている。 また2016年3月21日に吸入炭疽の予防・治療Antitoxinのモノクロナル抗体Obiltoxaximab(Anthim注[Elusys Therapeutics, Inc.])がFDA承認された。



[1413]●炭疽治療薬ラキシバクマブRaxibacumab(Raxibacumab[GSK])

 日本語版註)炭疽治療薬ラキシバクマブRaxibacumab(Raxibacumab[GSK])
 【別名】Abthrax 【開発元】Human Genome Sciences, Inc →3-Aug-2012GSKが買収  [DBR_ID]
 【化学名】Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of B.anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system.
 【承認】FDA申請=May-2009、FDA承認非勧告=16-Nov-2009、FDA再申請=15-Jun-2012、FDA承認勧告=2-Nov-2012、FDA承認=Dec. 14, 2012[Human Genome Sciences, Inc]、米国発売 ;
 【製剤】Each vial contains 50 mg/mL raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), and sucrose (10 mg/mL), with a pH of 6.5. 【適応】(肺炭疽病の治療だけでなく、代替薬がない場合か効果が不十分な場合の肺炭疽病の予防の適応) indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. 【用法用量】1)diphenhydramineを前投与 2)2時間15分かけて、成人はraxibacumabを40 mg/kg、50kg以上の小児は40 mg/kg、15-50kgの小児は60 mg/kg、15kg未満の小児は80 mg/kgを静脈内投与。
 【作用】Raxibacumab is a monoclonal antibody that binds free PA with an affinity equilibrium dissociation constant (Kd) of 2.78 ± 0.9 nM. Raxibacumab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin. It does not have direct antibacterial activity. 【特徴】Raxibacumab is a monoclonal antibody that binds the PA of B. anthracis 
 【添付文書】Raxibacumab-PI
 【提携】 【EU】 
 【日本】未開発 





【日本語版コメント1494〜炭疽に対するBioThraxとAnthrasil/2016.05.09】
炭疽菌は、その胞子は破壊しにくく、空中に容易に散布が可能なことからバイオテロリズムの道具として使用される恐れがある。2001年9月米国で、放送局や一部連邦議会議員に対して、郵便で炭疽菌が送付され、5名の死亡者、10名以上の負傷者を生んだバイオテロ事件が発生し、米国社会を大きく揺るがし、炭疽菌について世界中の注目を集めた。
現在日本で「炭疽」の適応を取得しているのは、アンピシリン、ベンジルペニシリンカリウム、テトラサイクリン塩酸塩、デメチルクロルテトラサイクリン塩酸塩、ミノサイクリン塩酸塩、ドキシサイクリン塩酸塩、シプロフロキサシン、ノルフロキサシン、レボフロキサシン、トスフロキサシントシル酸塩。
 吸入炭疽病治療薬炭疽病免疫グロブリンAnthrasilは吸入炭疽による毒血症治療薬としてFDA承認された唯一のポリクロナル抗体だが、炭疽治療薬のモノクロナル抗体ラキシバクマブRaxibacumab(ABthrax[GSK])もFDA承認を受けている。 また2016年3月21日に吸入炭疽の予防・治療Antitoxinのモノクロナル抗体Obiltoxaximab(Anthim注[Elusys Therapeutics, Inc.])がFDA承認された。  炭疽に対する沈降炭疽病ワクチンBioThraxは1970年にFDA承認されている古い薬剤だが、売上2016年は$237M



【日本語版コメント1413〜炭疽治療薬ラキシバクマブRaxibacumab(GSK)/2013.04.01】
炭疽菌は、その胞子は破壊しにくく、空中に容易に散布が可能なことからバイオテロリズムの道具として使用される恐れがある。2001年9月米国で、放送局や一部連邦議会議員に対して、郵便で炭疽菌が送付され、5名の死亡者、10名以上の負傷者を生んだバイオテロ事件が発生し、米国社会を大きく揺るがし、炭疽菌について世界中の注目を集めた。

現在日本で「炭疽」の適応を取得しているのは、アンピシリン、ベンジルペニシリンカリウム、テトラサイクリン塩酸塩、デメチルクロルテトラサイクリン塩酸塩、ミノサイクリン塩酸塩、ドキシサイクリン塩酸塩、シプロフロキサシン、ノルフロキサシン、レボフロキサシン、トスフロキサシントシル酸塩。 海外では、 炭疽菌ワクチンBiothrax[Emergent BioSolutions Inc]も販売されてる。



【日本語版コメント 1115〜生物兵器に対する治療薬およびワクチン/2001.10.15】  9月11日の同時多発テロに引き続き、10月に発生した炭疽菌による生物テロ。
 根本解決はともかく、政府・医療レベルでの応急体制は、早くも整ったと思われる。
 というのも、大きな話題にはなっていないが、米国は勿論のこと、日本でも生物テロ対策は一通り「生物兵器への対処に関する懇談会」(事務局:自衛隊)などで検討されてきた。http://www.jda.go.jp/j/library/delibe/

 2001.7.21 ワシントン・ポスト紙によると、ブッシュ政権は、生物兵器禁止条約(BWC)履行のための議定書案の交渉からも離脱する方針を正式に決めた。23日にスイス・ジュネーブで開かれる交渉で、米国代表が表明。京都議定書、包括的核実験禁止条約(CTBT)からの離脱方針に続き、同政権の「一国主義的傾向」。
生物兵器禁止条約は1972年に署名され、3年後に発効。生物兵器の開発、生産、貯蔵を全面禁止し、その破棄を定めている。署名当時は、生物兵器は軍事的有用性が限られていると認識されていたため、検証規定がなかった。

 2001.9.4 ニューヨーク・タイムズ紙は、米政府がクリントン前政権時から生物兵器の研究が秘密裏に行われ、ネバダ砂漠に「細菌工場」を建設したこと、ブッシュ政権はこれをさらに押し進める意向だと暴露。
 と、このような話しも最近あった。

バイオテロ対策マニュアル配布 日本救急医学会[医療ルネッサンス01.11.2]によると、
日本救急医学会は2001.10末迄にバイオテロに使われる恐れのある5種類の微生物が
引き起こす感染症の診断・治療法などをまとめたマニュアルを先月末までに、全国の大学
病院救急部や救命救急センターなど約300施設と都道府県医師会に緊急配布した。
 記載されているのは、米疾病対策センター(CDC)が「バイオテロで利用される危険
性が高い病原体」としている炭疽菌、ボツリヌス毒素、ペスト菌、天然痘ウイルス、野兎
(やと)病の細菌。米ジョンズホプキンス大の治療法などに基づいてまとめたもので、患
者の症状、治療方法、感染拡大の予防法などを実用的に紹介している。

 また病院側の対応ポイントとして「多くの場合、患者の初期症状はかぜに似ている」
「感染拡大の危険性があり、医療関係者の安全確保も必要」などと具体的に注意を呼びか
けている。  島崎理事長は「予備知識があれば、緊急時の適切な対応の助けになるだろ
う」と話している。
 
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●解説

防衛庁自衛隊 審議会等関係資料

●ワクチン等にかかる検討会
 (略)

●生物兵器への対処に関する懇談会
概要
議事録等
報告書等生物兵器への対処に関する懇談会報告書[2001年4月11日]
(参考資料)生物兵器となる可能性があるとされている生物剤について
(米国公刊資料等による)
生物剤 人から人
への感染
潜伏期 死亡率
(未治療の場合)
徴候と症状 治療 予防

炭疽菌 なし 1〜6日 皮膚:25%
吸入性及び腸:ほぼ100%
 発熱、咳、軽度の肺の不快感に続いて、チアノーゼを伴った重度の呼吸困難  
 重篤な症状が発現した後24〜36時間以内にショックや死に至る 
対症療法
抗生物質の投与 
ワクチンが有効
抗生物質の予防的投与
ブルセラ なし 5〜60日
平均1〜2か月
5%  不規則な熱、頭痛、倦怠感、悪寒、関節痛、筋肉痛、抑うつなどの精神症状 抗生物質の投与 ワクチンなし
コレラ菌 まれ 4時間〜5日
平均2〜3日
50%
(治療により低減)
 発熱、嘔吐、下痢、脱水症状、ショック 水分と電解質の補充
抗生物質の投与
死菌ワクチン弱毒生ワクチン
鼻疽菌、類鼻疽菌 低い 10〜14日 50%以上  発熱、悪寒、発汗、筋肉痛、頭痛、胸膜炎性の胸痛、頚部リンパ節腫脹、脾腫や全身性の丘疹や膿疹 抗生物質の投与 抗生物質の予防的投与
ペスト菌
 
○肺ペスト

高い

2〜3日

100%

 高熱、悪寒から、急速に進行して、チアノーゼを呈する呼吸不全、循環虚脱と出血傾向から死に至る

抗生物質の投与
対症療法

死菌ワクチンは無効
 ○腺ペスト ノミが媒介 2〜10日 50%  倦怠感、高熱が自然に進行し、敗血症となり、中枢神経系、肺などに波及 抗生物質の投与
対症療法
死菌ワクチンが有効
野兎病菌
 ○潰瘍腺型
なし 1〜21日
平均3〜5日
中等度  局所の潰瘍と所属リンパ節腫脹、発熱、悪寒、頭痛、倦怠感 抗生物質の投与 弱毒生ワクチン(治験中)
抗生物質の予防投与
 ○チフス型 なし 1〜21日
平均3〜5日
35%  発熱、頭痛、倦怠感、胸骨下不快感、衰弱、体重減少、乾性咳嗽 抗生物質の投与 弱毒生ワクチン(治験中)
抗生物質の予防投与
リケッチャ Q熱リケッチャ まれ 2〜14日
平均7日
非常に低い  発熱、咳嗽を伴った胸膜炎性胸痛 抗生物質の投与 Q熱ワクチンの接種
抗生物質の予防的投与
ウイルス 天然痘ウイルス 高い 平均12日 高〜中等度  急激に倦怠感、発熱等で始まり、2〜3日後、四肢顔面を中心に皮疹が現れ、膿疱性小疱疹となる 対症療法 天然痘ワクチン接種
再ワクチン接種
免疫グロブリンの投与
馬脳炎ウイルス
 ○ベネズエラ馬脳炎など
低い 1〜5日 1%未満  全身の不快感、弛張熱、頭痛、羞明、筋肉痛、吐き気、嘔吐、咳嗽、下痢 対症療法 ワクチン(治験中)
出血熱ウイルス
 ○エボラ出血熱
 ○マールブルグ病
 ○黄熱病
 ○ラッサ熱 など
中等度 4〜21日 5〜20%以上

エボラ出血熱では50〜90%

 易出血性、点状出血、低血圧、ショック、顔面、胸部の紅潮、浮腫を合併する倦怠感、筋肉痛、頭痛、嘔吐、下痢 集中的対症療法
抗生物質の投与
アルゼンチン出血熱には回復期血漿が有効
黄熱病ワクチン

ラッサ熱などには抗生物質の投与

毒素 ボツリヌス菌毒素 なし 1〜5日 高い
(呼吸補助により5%以下)
 眼瞼下垂、全身脱力、嚥下困難等の弛緩性麻痺から呼吸不全に陥る 気管内挿管と呼吸補助 抗毒素
ブドウ球菌性腸毒素B なし 3〜12時間 1%以下 発熱、悪寒、頭痛、筋肉痛、乾性の咳 対症療法 なし
リシン なし 18〜24時間 高い(毒素量、曝露方法に依存)  吸入曝露で、発熱、、咳、肺水腫、呼吸不全経口摂取で重症の胃腸症状、消化管出血 対症療法 なし
(参考資料)
生物・化学テロリズム:準備と対応のための戦略計画:米国疾病管理センター(CDC),2000
生物剤死傷者の医学的管理ハンドブック:米国陸軍感染症研究所(USAMRIID),1988
ジェーン化学生物ハンドブック第4版:フレデリック・R・シーデル,1899





厚生労働省●「炭疽が疑われる患者の診療のポイント」について[2001.10.26]

 国立感染症研究所並びに日本感染症学会において次のとおり「診療のポイント」をとり
まとめたので、公表いたします。

照会先	厚生労働省大臣官房厚生科学課
 (担当・内線) 佐藤 健康危機管理官(3814)
         西山 課長補佐 (3807)
 (電話)(代表)03(5253)1111
 (直通)03(3595)2171
--------------------------------------------------------------------------------
●1.臨床症状
1)肺炭疽
 肺炭疽の潜伏期は1−5日とされる。肺炭疽患者は発病初期には、発熱、乾性咳そう、筋肉痛、倦怠感などの急性ウイルス性上気道炎様症状を呈する。
 典型的な胸部レントゲン写真の所見(図1)は縦隔の拡大であり、これは出血性縦隔炎の徴候とみなされる。ただし発症早期にはみられないことが多いので、炭疽が疑われる場合には、例えば6時間毎に胸部レントゲン写真を撮り、縦隔の拡大の有無に留意すべきである。重症の場合は、胸水の貯留も認める。
 一過性に症状が軽快する場合もあるが、通常は発病後、数日(1−3日)以内で重症化し、半数近くに髄膜刺激症状を伴い、呼吸困難にて死に至る。早期の診断及び抗菌薬投与がきわめて重要。

2)皮膚炭疽
 多くの場合は頭頚部、手、前腕に病変が生じる。まずかゆみが生じた後、丘診が出現、1〜2日以内に水疱化し、その後、潰瘍を形成して中心が黒色を呈することが特徴である(図2)。周囲は浮腫状。痛みを伴うことは稀。約10%程度が菌血症に至る。

●2.検査
(詳細は別添:「米国CDCの炭疽菌同定のための基本的臨床検査プロトコル(抜粋):原文 文献(11)」を参照のこと) 1)胸部レントゲン検査
2)血液培養、髄液培養(抗菌薬投与前に施行すること) 3)病変部位からの組織や体液(皮膚病変の水疱、便等)の培養
4)病変部位の組織の病理学的検査や検体の塗抹検査 ※ 起因菌はBacillus anthracisである。このバシラス群に属する菌は他にもあるので、医師が「炭疽の疑い」と検査技師に告げないと、汚染したものとして処理されてしまう危険性がある。
 他のバシラス群との鑑別のポイントは以下の二つ。 ア ペニシリン感受性
 炭疽菌は通常ペニシリン感受性である。
※ 炭疽菌の中にはペニシリン耐性のものも報告されているので注意が必要である。
イ コロニーの性状
 血液培地では白〜灰白色で、白金耳で拾ったときその形態は崩れにくい。
5)PCR  当面、都道府県衛生研究所の一部でのみ対応可能。地元の衛生研究所での対応状況は電話等で確認のこと。

●3.治療
 治療については、参考文献(1)、(2)、(4)、(5)、(6)、(8)、(12)等を参考にしてください。

●4.その他
 肺炭疽はヒト−ヒト感染はないとされているが、皮膚炭疽はその病変部位から感染する危険性があるため、手袋、マスク着用など標準的予防策をとること。




●その他

放医研ニュース
 --- No.60: 4-7 (Oct. 2001)「Flash News: 炭疽病(Anthrax)について」
  by 重粒子医科学センター病院 山田 滋、森田 新六、辻井 博彦
  概要、疫学、病因、臨床的特徴、診断、治療、予防、病院としての対応策
 についてコンパクトに纏められ、参考になる。 2001.11.26現在Online未収録








●データ


●生物兵器

●CNN 米政府が生物兵器を秘密研究 「細菌工場」も [CNN 01.9.4] http://cnn.co.jp/2001/US/09/04/US.germ.weapon/ 米国が「生物兵器禁止条約」議定書を正式に拒否[CNN 01.7.25] http://cnn.co.jp/2001/US/07/25/reject.anti.germ.treaty/ ●外務省 化学・生物兵器の軍縮・不拡散に関する我が国の取り組み[外務省] ---生物兵器禁止条約(BWC)の概要[外務省 01.3.1] ●防衛庁>ライブラリ>審議会等関係資料 生物兵器への対処に関する懇談会:議事録|:報告書等防衛庁>ライブラリ>防衛関係条約等 細菌兵器(生物兵器)及び毒素兵器の開発、生産及び貯蔵の禁止並びに廃棄に関する条約[昭和五十七年六月八日] ●その他 自衛隊生物兵器部隊問題 by 日本共産党参議院議員緒方靖夫 細菌兵器(生物兵器)及び毒素兵器の開発、生産及び貯蔵の禁止並びに廃棄に関する条約の実施に関する法律 by RONの六法全書 on LINE
●メルマガ

●メルマガ 殺人病レポート by 黒木 燐 ---ウィルスを主にした病原体により発病する感染症について
●炭疽菌-CNN

炭そ菌、フロリダで3人目の感染者 事件捜査に[CNN 01.10.11] http://cnn.co.jp/2001/US/10/11/anthrax.3rd/index.html フロリダの炭そ菌、アイオワの研究所で培養された疑い[CNN 01.10.10] http://cnn.co.jp/2001/US/10/10/anthrax.lab/index.html 関連記事 炭そ菌感染、「自然発生でない」とCDC[CNN 01.10.10] 炭そ菌は郵便で送りつけられた? 捜査続く[CNN 01.10.9] 炭そ菌感染を「事件の可能性も視野に調査」 米司法長官[CNN 01.10.9] 炭そ菌、2人目の感染者  パソコンからも検出[CNN 01.10.8] 肺炭そで入院の男性が死亡 米病院発表[CNN 01.10.6] フロリダ男性が肺炭そで入院 テロとは無関係)[CNN 01.10.4]
●その他

人獣共通感染症(Zoonoses)講義 http://www.anex.med.tokushima-u.ac.jp/topics/ Zoonoses by 山内東大名誉教授 霊長類フォーラム:人獣共通感染症講義 http://www.shiga-med.ac.jp/IEA/zoonosis/zoonosis.html Zoonoses by 山内東大名誉教授 電網将校参謀本部 特殊兵器資料室 by ---生物化学兵器の種類と性質一覧表 ---生物兵器FAQ --- 国際社会の安全保障を脅かすイラクの大量破壊兵器開発計画ファクトシート by 在日米国大使館








●臨床ガイドラインなど

Primary Care Clinical Practice Guidelines 17:Bioterrorism

  • Bioterrorism - Nuclear, Biological, Chemical (NBC) Warfare

  • Organizations 2002 Mar 12, May 1,2,8,9,10,18
    
    







    ●総説記事・文献

    ■Bioterrorismとワクチン

    Technology Review - The ABCs of Battling Bioterrorism[May 9, 2001]
    http://www.techreview.com/web/pellerin/pellerin050901.asp
    
    While there have been no significant incidents of terrorism using biological or chemical agents since the 1995 sarin gas attack in a Tokyo subway, U.S. government agencies have been urgently preparing to counter a possible attack. The budget for work on biological defenses at the Defense Advanced Research Projects Agency, for example, went from nothing in 1996 to nearly $167 million in 2001.

    ★A Is for Anthrax

    Anthrax, caused by Bacillus anthracis, is associated with the historical origin of immunology. In 1881, Louis Pasteur's development of a vaccine to protect domesticated animals from anthrax infection was a breakthrough in the use of attenuated (weakened) virulent organisms as a vaccine strategy.

    Live attenuated anthrax vaccines have been widely used in veterinary medicine ever since. Similar vaccines have been licensed for human use in the former Soviet Union since 1953.

    In recent decades, there has been growing concern about the potential use of anthrax as a bioterrorist weapon. In 1983, Congress heard that a single anthrax-carrying plane flying over Washington, D.C., on a calm night could produce 1 to 3 million fatalities.

    "On that basis, the Defense Department decided for the first time in human history to vaccinate people not against an existing disease, but against the threat of using an organism to cause disease," said Arthur Friedlander, science advisor to the U.S. Army Medical Research Institute of Infectious Diseases in Frederick, MD.

    As a rule, U.S. troops are vaccinated before entering a combat zone where they could encounter biological agents. In the Gulf War, more than 250,000 doses of anthrax vaccine were administered, based on reports that Iraq could use anthrax as a biological weapon. That vaccine produced a 95 percent survival rate in rhesus monkeys, but how well it actually protects people against anthrax is still not known. In addition, some long-term health issues related to human use are still under study.

    A new vaccine candidate, suspended in a gel, has proved successful against aerosol delivery of anthrax in animal studies so far. The Army is currently working with the National Institutes of Health to develop it, Friedlander said. "It's in the final stages in terms of formulation, and we hope to be into human trials [of its safety] in the next year."

    ★B Is for Bubonic

    Plague, caused by Yersinia pestis, continues to occur in many places around the world, including the U.S. Southwest where a dozen or so cases are reported annually. Bubonic plague affects the lymph nodes; pneumonic plague, the lungs.

    The original plague vaccine provides some protection against bubonic plague in animal studies, but not against intake of Y pestis through the lungs. However, if it's used as a biological weapon, researchers expect that aerosol delivery is the most likely route. Untreated pneumonic plague is nearly always fatal.

    Efforts to develop a new vaccine center on a genetically engineered candidate called F1-V, now moving into clinical trials. "To date, in vitro and in vivo evaluation of this vaccine candidate satisfies criteria for efficacy, safety and stability," said Gerard Andrews, chief of the bacteriology division of the Army's Research Institute of Infectious Diseases.

    Andrews's research group is also considering a genetically engineered protein called Yersinia outer proteins, or Yops. A version called YopD seems to protect against a lethal dose in mice and needs further study.

    ★C Is for Comeback Killer

    The naturally occurring virus that causes smallpox was declared eradicated more than 20 years ago. As a result, manufacture of smallpox vaccine ground to a halt. Yet the possibility that smallpox, which has no cure, could be delivered to U.S. cities in an aerosol cloud is the most feared bioterrorist scenario.

    Biosafety Level 4 viruses, the most deadly of all, must be handled in special facilities designed to contain them. (Photo courtesy of Centers for Disease Control and Prevention)

    At the same time the smallpox virus was eradicated in nature, the Soviet Union began an extensive program to develop it as a biological weapon that could be carried via intercontinental missiles. Russia still maintains a smallpox research program, as well as the technological capability to produce the virus.

    Today the only smallpox virus known to exist is quarantined in two government research institutions?the CDC in Atlanta, GA, and the State Research Centre of Virology and Biotechnology in Novosibirsk, Russia. In compliance with a United Nations agreement, these last remaining supplies of the virus should be destroyed in 2002.

    From the pre-eradication era, 15.4 million doses of smallpox vaccine remain in the U.S. national stockpile. This amount "is probably insufficient to fully address the possible resurgence of smallpox transmission in the event of the intentional release of the virus as a bioterrorist weapon," said James LeDuc of the CDC's National Center for Infectious Diseases.

    Last September, Acambis was awarded a government contract to produce a new smallpox vaccine using modern cell-culture techniques. (The technology used to produce the existing vaccine is now outdated.) The initial target is 40 million doses?what LeDuc calls "a reasonable starting point for a national stockpile"?and the first production lots are expected in 2004.

    This new vaccine will be held in reserve and released only in the event of confirmed cases of smallpox. "Since we can't use volunteers for otherwise fatal diseases," said Friedlander, "the best we'll be able to do is develop evidence of efficacy in the best animal models and then produce as much compelling evidence as possible" that the vaccine will work the same way in people.

    ★D Is for Deadly in the Wild

    Other, more recently identified viruses, like Lassa and Ebola, are already at large?mainly in Africa?without viable vaccine programs to counteract them, said Joseph McCormick of the University of Texas-Houston's School of Public Health.

    Lassa fever infects 100,000 to 300,000 people a year with approximately 5,000 deaths. Ebola infects fewer people but has a much higher mortality rate.

    "The hospitalization rate [for Lassa fever] is 98 to 147 per 100,000 per year," McCormick said. "If we had a disease like that in the United States, do you think we'd have a serious vaccine program?"

    One reason we don't is that the Lassa and Ebola viruses require person-to-person contact to spread, unlike airborne smallpox or plague. As a result, they haven't been regarded as prime candidates for development as biological weapons.

    In addition, since they are mostly found among the poorest populations in Africa, vaccine manufacturers lack a sufficient market to support vaccine production, even though "there are good candidate vaccines already developed for both viruses," McCormick said.

    "It's somewhat of an irony to see that we are spending tens of millions of dollars on a vaccine for a disease that's eradicated," he added, "and there's virtually no money or very little money for these two vaccines."

    ★E Is for Emergency Response

    The CDC's strategic plan for addressing the deliberate release of biological or chemical agents depends on putting in place by 2004 a public health communication infrastructure, a network of diagnostic labs and an integrated disease surveillance and reporting system.

    The national electronic infrastructure will speed the exchange of emergency health information among local, state and federal health agencies. In addition, a Web site will be created to help disseminate information on bioterrorism preparedness and training, both for health-care workers and the public.

    Even if the United States manages to avoid the lethal threat of bioterrorism, the report says, tools developed in response to such potential hazards will help in natural disease outbreaks or industrial accidents.

    Cheryl Pellerin is a science writer based in Washington, D.C.
    
    ●Special Issue :Vaccines in Civilian Defense Against Bioterrorism []
    http://www.cdc.gov/ncidod/EID/vol5no4/russell.htm
    Emerging Infectious Diseases 5(4), Jul-Aug 1999
    by Philip K. Russell
    Johns Hopkins School of Public Health, Baltimore, Maryland, USA
    
    The Department of Defense Joint Vaccine Acquisition Program has
    several experimental vaccines in development (Table). These
    vaccines will be further developed and tested with the intent of
    obtaining products licensed by the U.S. Food and Drug
    Administration.
    
    Table. Vaccines against biological agents
      ------------------------------------------------------
      Licensed vaccines        Vaccines in research
                               and development
      ------------------------------------------------------
      Anthrax                  Vaccinia (cell culture)
      Smallpox (vaccinia)      Botulinum toxoids
      Plague                   Tularemia
                               Q fever
                               VEE EEE WEE
      ------------------------------------------------------
    VEE, Venezuelan equine encephalitis; EEE, Eastern equine  
    encephalitis; WEE, Western equine encephalitis.
    
    ●Anthrax
    ANTHRAX VACCINE HOME PAGE
    Bioterrorism Alleging Use of Anthrax and Interim Guidelines for ManagementUnited States, 1998
     ---JAMA Vol. 281 No. 9,March 3, 1999
    Morbidity and Mortality Weekly Report MMWR. 1999;48:69-74
    
    
    







    ●ニュース・トピックス

    バイオテロ対策マニュアル配布 日本救急医学会[医療ルネッサンス01.11.2]

    日本救急医学会は2001.10末迄にバイオテロに使われる恐れのある5種類の微生物が引き起こす感染症の診断・治療法などをまとめたマニュアルを先月末までに、全国の大学病院救急部や救命救急センターなど約300施設と都道府県医師会に緊急配布した。
     記載されているのは、米疾病対策センター(CDC)が「バイオテロで利用される危険 性が高い病原体」としている炭疽菌、ボツリヌス毒素、ペスト菌、天然痘ウイルス、野兎 (やと)病の細菌。米ジョンズホプキンス大の治療法などに基づいてまとめたもので、患 者の症状、治療方法、感染拡大の予防法などを実用的に紹介している。

     また病院側の対応ポイントとして「多くの場合、患者の初期症状はかぜに似ている」 「感染拡大の危険性があり、医療関係者の安全確保も必要」などと具体的に注意を呼びか けている。  島崎理事長は「予備知識があれば、緊急時の適切な対応の助けになるだろう」と話している。

    
    







    ●リンク&リソース

    厚生労働省「米国の同時多発テロ関係」ホームページ

    ○2001/09/19掲載米国同時多発テロに伴う精神科医師等の派遣について
    ○2001/09/14掲載米国における同時多発テロ事件に関する健康危機管理対応について

     ○「米国における同時多発テロ事件関係」リンク集

     註)首相官邸:米国における同時多発テロ事件関連リンク
     のほうが、最新のようだ。 他省庁のページも含む。
    
    



    厚生労働省「国内の緊急テロ対策関係」ホームページ

    ○2001/10/26掲載第2回緊急テロ対策本部会議終了後報告メモについて
    ○2001/10/26掲載「炭疽が疑われる患者の診療のポイント」について
    ○2001/10/19更新福島県内の郵便局で発見された不審な郵便物に対する厚生労働省の対応
    ○2001/10/18掲載炭疽菌等の汚染のおそれのある郵便物等の取扱いについて(検査を含めた対応の流れ)(平成13年10月18日科発第467号等通知)
    ○2001/10/18掲載炭疽に関する意見書(社団法人 日本感染症学会)について
    ○2001/10/18掲載炭疽菌の検査法に関する講習会の開催について(平成13年10月17日通知)
    ○2001/10/16掲載病原性微生物等の管理の強化について(平成13年10月15日科発第456号通知)
    ○2001/10/15掲載生物兵器テロの可能性が高い感染症について
    ○2001/10/15掲載「米国の同時多発テロ」における炭疽菌等の汚染のおそれのある封筒等の取扱い方法について
    ○2001/10/12掲載国内における生物テロ事件発生を想定した対応について(平成13年10月11日通知)
    ○2001/10/09掲載「米国の同時多発テロ」を契機とする国内におけるテロ事件発生に関する対応について(平成13年10月8日科発第443号通知)
    ○2001/10/05掲載「米国の同時多発テロ」を契機とする国内におけるテロ事件発生に関する対応について(平成13年10月4日科発第438号等通知)

     ○「米国における同時多発テロ事件関係」リンク集[省略]
    
    



    ●日本医師会米国における同時多発テロ事件に関連して

    日本医師会感染症危機管理対策室
    ■米国疾病管理センター:CDC 2001年10月17日付け 肺炭疽症の予防投与のための暫定的ガイドライン日本語要旨(10/23一部改訂)
    ■米国疾病管理センター:CDC 2001年10月16日付け公式発表の日本語訳
    ■バイオテロリズムの脅威−生物兵器(炭疽菌)によるテロリズム−(10/23一部改訂)
    
    ■日医発信文書
     ■「米国の同時多発テロ」を契機とした国内における生物兵器への対応について(平成13年10月12日(地III114)都道府県医師会宛)
     ■「米国の同時多発テロ」を契機とした国内における生物兵器への対応について(平成13年10月15日(地III115)郡市区医師会宛)
     ■国内における生物テロ事件発生を想定した対応について(平成13年10月16日(地III117)都道府県医師会宛)(PDF)
    
    ■米国における同時多発テロ事件に関する健康危機管理対応について
    (HTML版:厚生労働省HP)(PDF版)
    ■感染症危機管理対策協議会講演録・生物兵器への対応について   (帝京大学教授・志方 俊之:平成13年3月16日実施)
    
    ■日医雑誌生涯教育シリーズ「感染症の診断・治療ガイドライン」より
      ■炭疽(PDF)
      ■ペスト(PDF)
      ■乳児ボツリヌス症(PDF)
    
    ■関連リンク
    ■天然痘(感染症発生動向調査週報〜感染症の話)(国立感染症研究所感染症情報HP)
    ■生物兵器への対処に関する懇談会報告書(平成13年4月11日)(防衛庁 自衛隊HP)
    ■不審な郵便物への対処方法等についてのお知らせ(ゆうびんHP)
    
    



    Yahoo! Bioterrorism

    Home > Society and Culture > Crime > Types of Crime > Terrorism > Bioterrorism 
    
    Yahoo! Headline News
    Site Listings
    Biological Warfare Defense
     - outlines a nine-step plan for a national defense system against bioterror attacks.
    IDSA and Bioterrorism Preparedness
     - from the Infectious Diseases Society of America.
    APIC: Bioterrorism Resources
     - collection of articles.
    Assessing the Threat of Bioterrorism
     - congressional testimony from 1999 by Raymond Zilinskas, from the Center for Nonproliferation Studies.
    Bioterrorism: Implications for Public Health
     - panel discussion from Public Health Grand Rounds, June 1999.
    CBACI.org: Bioterrorism in the United States - Threat, Preparedness, and Response
     - includes reports on public health and medical response, recommendations, and more.
    CDC: Bioterrorism Preparedness and Response
     - with the CDC's bioterorism initiative, interim notification procedures for public health department leaders, news items, and more.
    Center for the Study of Bioterrorism and Emerging Infections - Saint Louis University
     - with information current research projects, key references, news, case studie
     s, education and training resources, and more.
    House.gov: Subcommittee on National Security Briefing Memo
     - April 2001 congressional hearing to discuss the internal control and GAO reco
     mmendations regarding medical stockpile management against the threat of chemic
     al and biological terrorist attacks.
    Johns Hopkins University: Center for Civilian Biodefense Studies
     - fosters the development of national and international medical and public heal
     th policies and structures to protect the civilian population from bioterrorism.
    Medscape Resource Center: Bioterrorism - Preparing for the Future
     - with articles, conference summaries, commentary, journal scans, and more.
    NACCHO: Bioterrorism and Emergency Response
     - from the National Association of County and City Health Officials.
    National Symposium on Medical and Public Health Response to Bioterrorism
     - with audio files of the presentations, from February 1999.
    New Age of Terrorism, A
     - special report from ABC News.
    New Scientist: Bioterrorism and Bioweapons Special Report
     - includes information on recent events as well as archived articles.
    The Threat Of Bioterrorism And The Spread Of Infectious Diseases
     - Sept 5, 2001 Congressional testimony from Frank Cilluffo from the Center For 
     Strategic and International Studies.
    
    



    Google:Biological and Chemical Terrorism

    Society > Issues > Terrorism > Biological and Chemical Terrorism 
    
    ●Categories
    Anthrax(9)
    Articles(13)
    Government Sites(8)
    Online Publications(3)
    Reference(5)
    Sarin Nerve Gas(2)
    ●Related Categories: 
    Shopping > Home and Garden > Emergency Supplies > Equipment > Gas Masks (7)
    Society > Issues > War, Weapons and Defense > Biological and Chemical (67)
    ●Web Pages
    National Domestic Preparedness Office-http://www.ndpo.gov/
    --- FBI department that coordinates federal efforts to assist state and local emergency responders with planning, training, equipment, and exercise needs necessary to respond to a weapon of mass destruction incident.
    FEMA -- Preparedness-http://www.fema.gov/pte/
    --- US Federal information tasked with supporting state and local government programs for prepare for and respond to a chemical, radiological or other hazardous materials emergencies. Includes program information, news, contacts, and handbooks.
    Chemical Emergency Preparedness and Prevention Office-http://www.epa.gov/swercepp/
    --- Home Page of the U.S. Environmental Protection Agency's Chemical Emergency Preparedness and Prevention Office - CEPPO
    Center for Civilian Biodefense Studies-http://www.hopkins-biodefense.org/
    --- The Johns Hopkins Center for Civilian Biodefense Studies fosters the development of national and international medical and public health policies and structures to protect the civilian population from bioterrorism.
    Bioterrorism Preparedness and Response-http://www.bt.cdc.gov/
    --- Information from the Center for Disease Control and Prevention agency that provides current news, emergency contacts, biological agents. learning resources, and official statements on biological terrorism.
    Emergency Response to Chemical/Biological Terrorism-http://www.emergency.com/cbwlesn1.htm
    --- Report on American preparedness for a chemical or biological weapons attack by terrorists. Includes a discussion of readiness, procedures, and bibliography of related print and Web sources.
    EID V3 N2: Biologic Terrorism -- Responding to the Threat-http://www.cdc.gov/ncidod/EID/vol3no2/russell.htm
    The Economic Impact of a Bioterrorist Attack-http://www.cdc.gov/ncidod/EID/vol3no2/kaufman.htm
    --- Are Prevention and Postattack Intervention Programs Justifiable? CDC, Emerging Infectious Diseases.
    Bioterrorism Preparedness and Response-http://www.cdc.gov/ncidod/diseases/bioterr.htm
    --- from the CDC with links to other resources.
    Medical NBC Online-http://www.nbc-med.org/others/
    --- Nuclear Biological and Chemical medical information from the Office of the Surgeon General of the Army. Includes news, medical references and handbooks, training, calendar, glossary.
    Civilian Emergency Response to Chemical or Biological Weapons Incidents Project-http://www4.nas.edu/cp.nsf/57b01c7b1b6493c485256555005853cf/a3861123d7632dc4852565690079b6f9?OpenDocument
    --- News from the National Academy's Institute of Medicine.
    Nightline: Biowar Series-http://abcnews.go.com/onair/Nightline/nl991001_biowar.html
    --- A fictional metropolitan city faces an anthrax terrorist attack.
    Chem-Bio Resource Center-http://www.chem-bio.com/resource/
    --- Information, handbooks, FAQs, and documents released by the U.S. government and other organizations related to chemical and biological terrorism.
    Bioslate - Are We Prepared for Chemical/Biological Attacks?-http://www.cdi.org/adm/chemshow/index.html
    --- A look at the governments attempt to prepare for a biological or chemical attack on U.S. soil. Domestic and international terrorism are at the center of this fascinating and informative television program.
    Terrorist Use of Chemical Weapons-http://www.public.asu.edu/~auasg/research/cwpaper.html
    --- Discusses types of chemical weapons, the advantages and disadvantages of them as weapons of terror, and ways to improve response capabilities.
    Non State Actors and Biological Weapons: A Credible Threat?-http://members.netscapeonline.co.uk/hannahgreg1
    --- Discusses biological agents, the technical capabilities terrorist groups to develop and deploy these weapons, terrorists' motives for using such armaments, and future scenarios for their using these weapons.
    Biological Terrorism - Background Briefing-http://www.abc.net.au/rn/talks/bbing/stories/s48674.htm
    --- From a symposium on bio terrorism, hosted by the International Union of Microbiological Societies. [8/29/99]
    Anthrax and Biological Weapons-http://nov55.com/biow.html
    --- This web site describes the biology of anthrax and other biological weapons showing that they are hyped as part of an anti-terrorist campaigm.By Gary Novak
    Protective Research Group-http://www.proresearchgroup.com
    --- Terrorism, nuclear, biological, chemical terrorism, child safety, personal and executive protection consulting. Downloadable free articles. Safety tips, issues and anti-terrorism information.
    Criminal / Terrorist Use of Chemical / Biological Agents-http://www.rcmp-learning.org/docs/ecdd1022.htm
    --- Difference between Chemical and Biological Agents , cquisition of Agents , Indicators of Possible Chemical or Biological Incident , Chemical Incidents and Biological Incidents , Canadian Response to Chemical and Biological Terrorism . From the Learning and Development Branch, Human Resources Directorate, RCMP
    Chemical/Biological/Nuclear Anti-Terrorism Page-http://www.mindspring.com/~nbcnco
    --- Survive a terrorist attack with information on chemical/biological agents, their use, where to find and use antidotes and decontaminants.
    Chemical and Biological Agents and Threats-http://www.outbreak.org/cgi-unreg/dynaserve.exe/cb/bionews.html
    --- the latest news. Includes: weapons controversy between UN And Iraq, US Anthrax scares. Description of various biological and chemical agents.
    
    



    MEDLINEplus: Biodefense and Bioterrorism

    Contents of this page:
    News
    General/Overviews
    Alternative Therapy
    Coping
    Prevention/Screening
    Research
    Specific Conditions/Aspects
    Treatment
    Law and Policy
    Organizations
    Children
    Search MEDLINE for recent research articles on
    Biodefense and Bioterrorism:
    ・ Biological warfare & bioterrorismChemical warfareRicin
    You may also be interested in these MEDLINEplus related pages:
    ・ AnthraxBotulismDisasters and Emergency PreparednessHemorrhagic FeversImmunization/VaccinationInfectious Diseases (General)PlagueSmallpoxPoisoning, Toxicology, Environmental HealthLatest News
    CDC Focuses on 'Highest' Risks (02/12/2003, New York Times Syndicate)
    Coping with Anxiety During High Risk Terrorist Alerts (02/12/2003, American Psychiatric Association)
    Smallpox Vaccinations Show No Problems Yet (02/07/2003, United Press International)
    EPA Opens New Environmental Emergency Response Center (02/06/2003, Environmental Protection Agency)
    FDA Approves Pyridostigmine Bromide as Pretreatment Against Nerve Gas (02/05/2003, Food and Drug Administration)
    FDA Urges 'Dirty Bomb' Treatment (01/31/2003, Associated Press)
    More News on Biodefense and BioterrorismGeneral/Overviews
    Biological Diseases/Agents (Centers for Disease Control and Prevention)
    Biological Warfare: Questions and Answers (Mayo Foundation for Medical Education and Research)
    Biological, Chemical Weapons: Arm Yourself with Information (Mayo Foundation for Medical Education and Research)
    Chemical Agents (Centers for Disease Control and Prevention)
    TOXNET Databases (National Library of Medicine) - journal citations and data files on toxicology and related subjects
    
    ●Alternative Therapy
    Bioterrorism and CAM (Complementary and Alternative Medicine): What the Public Needs To Know (National Center for Complementary and Alternative Medicine)
    
    ●Coping
    Coping with Anxiety During High Risk Terrorist Alerts (American Psychiatric Association)
    Coping with Bioterrorism Anxiety: Advice from the American Psychiatric Association (American Psychiatric Association)
    Handbook for Coping After Terrorism (Dept. of Justice, Office for Victims of Crime)
    Also available in:  Spanish
    Mental Health Aspects of Terrorism (Center for Mental Health Services)
    
    ●Prevention/Screening
    President Details Project BioShield (White House)
    
    ●Research
    Research on Medical Tools to Combat Bioterrorism (National Institute of Allergy and Infectious Diseases)
    
    ●Specific Conditions/Aspects
    Are You Ready? A Guide to Citizen Preparedness (Federal Emergency Management Agency)
    Brucellosis (National Center for Infectious Diseases, Division of Bacterial and Mycotic Diseases)
    Chemical Emergency (Federal Emergency Management Agency)
    Facts about Cyanide (Centers for Disease Control and Prevention)
    Facts about Sarin (Centers for Disease Control and Prevention)
    Facts about VX (Centers for Disease Control and Prevention)
    Frequently Asked Consumer Questions About Food Safety and Terrorism (Food and Drug Administration)
    Frequently Asked Questions (FAQ) about Ricin (Centers for Disease Control and Prevention)
    Glanders (National Center for Infectious Diseases, Division of Bacterial and Mycotic Diseases)
    Melioidosis (National Center for Infectious Diseases, Division of Bacterial and Mycotic Diseases)
    Mustard Gas (Agency for Toxic Substances and Disease Registry)
    Nerve Agents (GA, GB, GD, VX) (Agency for Toxic Substances and Disease Registry)
    Q Fever (Centers for Disease Control and Prevention)
    Ricin (Arizona Dept. of Health Services)
    Tularemia (Johns Hopkins University, Center for Civilian Biodefense Strategies)
    Tularemia FAQ's (Centers for Disease Control and Prevention)
    
    ●Treatment
    National Pharmaceutical Stockpile Program Synopsis (Centers for Disease Control and Prevention)
    Offers to Treat Biological Threats: What You Need to Know (Federal Trade Commission)
    Also available in:  SpanishLaw and Policy
    Bioterrorism Act of 2002 (Food and Drug Administration)
    FDA Amends its Regulations to Provide for Approval of Certain New Pharmaceutical Products Based on Animal Efficacy Data (Food and Drug Administration)
    Select Agent Rule (Centers for Disease Control and Prevention)
    
    ●Organizations
    Department of Homeland Security (White House)
    EPA Chemical Emergency Preparedness and Prevention Office (Environmental Protection Agency)
    Johns Hopkins University, Center for Civilian Biodefense Strategies
    Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention)
    Also available in:  Spanish
    U.S. Army Medical Research Institute of Infectious DiseasesChildren
    Anthrax/Bioterrorism Q and A (American Academy of Pediatrics)
    Talking to Children about Terrorism and War (American Academy of Child and Adolescent Psychiatry)
    Youngest Victims: Disaster Preparedness to Meet Children's Needs (American Academy of Pediatrics)
    Page last updated: 13 February 2003
    
    
    
    
    MEDLINEplus: Poisoning, Toxicology, Environmental Health Topics

    Air Pollution Anthrax Arsenic Asbestos/Asbestosis Biodefense and Bioterrorism Biological Weapons see Biodefense and Bioterrorism Bioterrorism see Biodefense and Bioterrorism Campylobacter see Food Contamination/Poisoning Carbon Monoxide Poisoning Cell Phones see Electromagnetic Fields Chemical Weapons see Biodefense and Bioterrorism Cleaning Products see Household Poisons Drinking Water EMF see Electromagnetic Fields Electromagnetic Fields Environmental Health Environmental Tobacco Smoke see Secondhand Smoke Food Contamination/Poisoning Food Safety Fungicides see Pesticides Germ Warfare see Biodefense and Bioterrorism Hazardous Waste see Environmental Health Herbicides see Pesticides Household Poisons Indoor Air Pollution Insecticides see Pesticides Lead Poisoning Mercury Mesothelioma see Asbestos/Asbestosis Molds Noise Ozone Passive Smoking see Secondhand Smoke Pesticides Poisoning Poisons in the Home see Household Poisons Q Fever see Biodefense and Bioterrorism Radiation Exposure Radon Rodenticides see Pesticides Secondhand Smoke Smallpox Smoking, Passive see Secondhand Smoke Tularemia see Biodefense and Bioterrorism Water see Drinking Water Yersinia see Food Contamination/Poisoning Page last updated: 01 November 2001
    MEDLINEplus: Anthrax

    Contents of this page: News From the NIH General/Overviews Alternative Therapy Clinical Trials Diagnosis/Symptoms Pictures/Diagrams Prevention/Screening Research Specific Conditions/Aspects Treatment Law and Policy Organizations Children Teenagers Women Search MEDLINE for recent research articles on ・ Anthrax You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismInfectionsPoisoning, Toxicology, Environmental Health Latest News Office Activity Stirs Up Weeks-old Anthrax Spores (12/10/2002, Reuters Health) Bioweapon Rules Not Foolproof (12/09/2002, United Press International) From the National Institutes of Health Anthrax (National Institute of Allergy and Infectious Diseases) ★General/Overviews Anthrax (Patient Education Institute) - requires Flash plug-in Anthrax: Frequently Asked Questions (National Center for Infectious Diseases) Also available in: Spanish FAQs about Anthrax (Centers for Disease Control and Prevention) What is Anthrax? (Nemours Foundation) ★Alternative Therapy Bioterrorism and CAM (Complementary and Alternative Medicine): What the Public Needs To Know (National Center for Complementary and Alternative Medicine) ★Clinical Trials ClinicalTrials.gov: Anthrax (National Institutes of Health) ★Diagnosis/Symptoms What's the Difference Between Flu and Anthrax Symptoms? (Food and Drug Administration) ★Pictures/Diagrams Cutaneous Anthrax -- Vesicle Development (Centers for Disease Control and Prevention) Inhalational Anthrax (Centers for Disease Control and Prevention) ★Prevention/Screening Anthrax Vaccination (National Network for Immunization Information) Anthrax Vaccine (Centers for Disease Control and Prevention) How We're Making the Public and Employees Safe (United States Postal Service) Irradiated Mail (Environmental Protection Agency, Office of Air and Radiation) Updated Information About How to Recognize and Handle a Suspicious Package or Envelope (Centers for Disease Control and Prevention) ★Research Answers on Anthrax (National Institute of General Medical Sciences) Anthrax Findings Presented by NIH Researcher (National Institutes of Health, Clinical Center) Molecular Mechanism Underlying Anthrax Infection Described by NIEHS-funded Researchers (National Institute of Environmental Health Sciences) Researchers Discover Secrets of Anthrax's Killer Toxin (National Institute of Allergy and Infectious Diseases) Researchers Unravel Anthrax Genomes (National Institute of Allergy and Infectious Diseases) ★Specific Conditions/Aspects Anthrax in the Workplace (Occupational Safety and Health Administration) Offers to Treat Biological Threats: What You Need to Know (Federal Trade Commission) Also available in: SpanishTreatment Cipro (Ciprofloxacin Hydrochloride)for Inhalation Anthrax (Food and Drug Administration) Patient Information on Amoxicillin (Centers for Disease Control and Prevention) Patient Information on Ciprofloxacin (Centers for Disease Control and Prevention) Questions and Answers for Consumers on Doxycycline (Center for Drug Evaluation and Research) Questions and Answers for Consumers on Penicillin G Procaine (Center for Drug Evaluation and Research) ★Law and Policy FTC Announces First Two Enforcement Actions Against Purveyors of Bioterrorism Defense Products (Federal Trade Commission) ★Organizations Anthrax Vaccine Immunization Program (Dept. of Defense) Johns Hopkins University, Center for Civilian Biodefense Strategies National Institute of Allergy and Infectious Diseases Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention) Also available in: SpanishChildren Anthrax/Bioterrorism Q and A (American Academy of Pediatrics) Children and Anthrax: A Fact Sheet for Parents (Centers for Disease Control and Prevention) What is Anthrax? (Nemours Foundation) ★Teenagers What Is Anthrax? (Nemours Foundation) ★Women Guidelines for Pregnant Women Who Have Been Exposed to Anthrax But Do Not Have Symptoms (National Center on Birth Defects and Developmental Disabilities) Interactive Tutorial View slideshow on: Anthrax Page last updated: 11 December 2002
    MEDLINEplus: Botulism

    Contents of this page: General/Overviews Clinical Trials Diagnosis/Symptoms Prevention/Screening Specific Conditions/Aspects Organizations Children Search MEDLINE for recent research articles on ・ Botulism You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismBotoxFood Contamination/PoisoningFood SafetyInfectionsGeneral/Overviews Botulism: Frequently Asked Questions (National Center for Infectious Diseases) Facts about Botulism (Centers for Disease Control and Prevention) ●Clinical Trials ClinicalTrials.gov: Botulism (National Institutes of Health) ●Diagnosis/Symptoms Electromyography and Nerve Conduction Velocities (Muscular Dystrophy Association) ●Prevention/Screening Frozen, Fully-Cooked Products and Botulism--Food Safety Advisory (Dept. of Agriculture, Food Safety and Inspection Service) ●Specific Conditions/Aspects Botulinum Toxin (Johns Hopkins University, Center for Civilian Biodefense Strategies) ●Organizations Food and Drug Administration National Center for Infectious Diseases, Division of Bacterial and Mycotic Diseases National Institute of Allergy and Infectious DiseasesChildren Honey: Safe for Infants? (Mayo Foundation for Medical Education and Research) Infant Botulism (Nemours Foundation) Page last updated: 03 February 2003
    MEDLINEplus: Disasters and Emergency Preparedness

    Contents of this page: News General/Overviews Coping Specific Conditions/Aspects Directories Law and Policy Organizations Children Seniors Teenagers Search MEDLINE for recent research articles on Disasters and Emergency Preparedness: ・ Disaster planningNatural disastersRelief work You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismFirst Aid/EmergenciesHeat IllnessHypothermiaPost-Traumatic Stress DisorderSafetyLatest News CDC Focuses on 'Highest' Risks (02/12/2003, New York Times Syndicate) Shrimp Is Secret Ingredient in New US Army Bandage (02/06/2003, Reuters Health) Health Woes Linger in Trade Center Workers (01/27/2003, Reuters Health) ●General/Overviews Are You Ready? A Guide to Citizen Preparedness (Federal Emergency Management Agency) Family Readiness Kit : Preparing to Handle Disasters (American Academy of Pediatrics) Your Family Disaster Plan: 4 Steps to Safety (Federal Emergency Management Agency) ●Coping Common Reactions to Trauma (National Center for PTSD) Coping with a Traumatic Event (National Center for Injury Prevention and Control) Coping with Uncertainty: A 4-Step Plan (Mayo Foundation for Medical Education and Research) Funerals and Memorials: A Part of Recovery (American Psychiatric Association) Handbook for Coping After Terrorism (Dept. of Justice, Office for Victims of Crime) Also available in: Spanish Helping Children and Adolescents Cope with Violence and Disasters (National Institute of Mental Health) Mental Health Aspects of Terrorism (Center for Mental Health Services) Self Care and Self-Help Following Disasters (National Center for PTSD, Dept. of Veterans Affairs) Self-Care Tips for Emergency and Disaster Response Workers (Center for Mental Health Services) Survivors of Disasters (National Center for PTSD, Dept. of Veterans Affairs) Survivors of Natural Disasters (National Center for PTSD, Dept. of Veterans Affairs) ●Specific Conditions/Aspects Animal Safety (American Red Cross) Are You Ready for a Fire? (American Red Cross) Also available in: Spanish Are You Ready For a Flood or a Flash Flood? (American Red Cross) Brain Injuries and Mass Trauma Events (National Center for Injury Prevention and Control) Chemical Emergency (Federal Emergency Management Agency) Cleaning Up the World Trade Center-Safely (National Institute of Environmental Health Sciences) Disaster Preparedness for People With Disabilities (American Red Cross) Earthquake (National Center for Environmental Health) Eye Safety for Emergency Response and Disaster Recovery (National Institute for Occupational Safety and Health) Also available in: Spanish Flood (National Center for Environmental Health) Food and Water in an Emergency (Federal Emergency Management Agency) Hurricane (National Center for Environmental Health) Injuries and Mass Trauma Events (National Center for Injury Prevention and Control) Keeping Food Safe During an Emergency (Dept. of Agriculture, Food Safety and Inspection Service) Also available in: Spanish Landslides and Mudflows (Federal Emergency Management Agency) Mass Trauma: Burns (National Center for Injury Prevention and Control) Nuclear Event Response (National Center for Environmental Health) Nuclear Power Plant Emergency (Federal Emergency Management Agency) Pets and Disasters (Federal Emergency Management Agency) Private Wells: Guidance for What to Do After the Flood (Environmental Protection Agency, Office of Water) Rolling Blackouts: Safety Information for Short-Term Power Outages or "Rolling Blackouts" (American Red Cross) Sheltering in Place During a Radiation Emergency (National Center for Environmental Health) Staying Warm in an Unheated House: Coping With A Power Outage In Winter (National Institute for Occupational Safety and Health) Terrorism (Federal Emergency Management Agency) Terrorism: Preparing for the Unexpected (American Red Cross) Thunderstorms and Lightening (Federal Emergency Management Agency) Tornado: A Guide for Your Personal Health and Safety (National Center for Environmental Health) Tsunami (Federal Emergency Management Agency) Volcano (Federal Emergency Management Agency) When Lightning Strikes: Know What to Do Before and After (Mayo Foundation for Medical Education and Research) Wildland Fires (Federal Emergency Management Agency) Winter Preparedness Safety Tips (Federal Emergency Management Agency) ●Directories Concerned Citizens Resources (Environmental Protection Agency) Disaster Finder (National Aeronautics and Space Administration) - State offices of emergency services ●Law and Policy EPCRA (Emergency Planning and Community Right-to-Know Act) Overview (Environmental Protection Agency) Response & Recovery (Federal Emergency Management Agency) ●Organizations American Red Cross Federal Emergency Management Agency Mass Trauma Preparedness and Response (National Center for Injury Prevention and Control) United States Agency for International DevelopmentChildren Coping With Disaster: Suggestions for Helping Children With Cognitive Disabilities (Administration for Children and Families) FEMA For Kids (Federal Emergency Management Agency) Helping Children Cope with Disaster (Federal Emergency Management Agency) Helping Children Cope with Fear and Anxiety (Center for Mental Health Services) Also available in: Spanish Talking to Children about War and Terrorism: 20 Tips for Parents (American Psychiatric Association) Terrorism and Children (National Center for PTSD, Dept. of Veterans Affairs) ●Seniors Coping with Disaster: Tips for Older Adults (National Mental Health Association) Disaster Preparedness for Seniors by Seniors (American Red Cross) Also available in: Spanish Tips For Talking About Disasters: Older Adults (Center for Mental Health Services) ●Teenagers Coping With Disaster: Tips for College Students (National Mental Health Association) Dealing with the Terrorist Attacks (Nemours Foundation) Page last updated: 13 February 2003
    MEDLINEplus: Hemorrhagic Fevers

    Contents of this page: News General/Overviews Specific Conditions/Aspects Organizations Search MEDLINE for recent research articles on ・ Hemorrhagic Fevers You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismDengueViral InfectionsInfectionsLatest News Suspected Ebola Virus Kills Nearly 50 in Congo (02/12/2003, Reuters Health) ●General/Overviews Viral Hemorrhagic Fevers (Johns Hopkins University, Center for Civilian Biodefense Strategies) Viral Hemorrhagic Fevers (National Center for Infectious Diseases) ●Specific Conditions/Aspects All about Hantavirus (National Center for Infectious Diseases) Crimean-Congo Haemorrhagic Fever (World Health Organization) Ebola Haemorrhagic Fever (World Health Organization) Filoviruses (National Center for Infectious Diseases) Viral Hemorrhagic Fevers: Lymphocytic Choriomeningitis (Centers for Disease Control and Prevention) Viral Hemorrhagic Fevers: Arenaviridae (National Center for Infectious Diseases) Viral Hemorrhagic Fevers: Ebola Hemorrhagic Fever (National Center for Infectious Diseases) Viral Hemorrhagic Fevers: Lassa Fever (National Center for Infectious Diseases) Viral Hemorrhagic Fevers: Marburg Fever (National Center for Infectious Diseases) Viral Hemorrhagic Fevers: Rift Valley Fever (National Center for Infectious Diseases) ●Organizations National Center for Infectious Diseases National Institute of Allergy and Infectious Diseases Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention) Also available in: Spanish WHO/OMS: World Health Organization (World Health Organization) Page last updated: 13 February 2003




    MEDLINEplus: Plague

    Contents of this page:
    General/Overviews
    Diagnosis/Symptoms
    Pictures/Diagrams
    Prevention/Screening
    Research
    Specific Conditions/Aspects
    Organizations
    Statistics
    Search MEDLINE for recent research articles on
    ・ Plague
    You may also be interested in these MEDLINEplus related pages:
    ・ Biodefense and BioterrorismInfectionsGeneral/Overviews
    Information on Plague (Centers for Disease Control and Prevention)
    Plague (World Health Organization)
    Questions and Answers About Plague (National Center for Infectious Diseases)
    
    ★Diagnosis/Symptoms
    Plague: Diagnosis (Centers for Disease Control and Prevention)
    
    ★Pictures/Diagrams
    Plague Images (Centers for Disease Control and Prevention)
    
    ★Prevention/Screening
    Plague: Prevention (Centers for Disease Control and Prevention)
    
    ★Research
    Plague (National Institute of Allergy and Infectious Diseases)
    
    ★Specific Conditions/Aspects
    Facts about Pneumonic Plague (Centers for Disease Control and Prevention)
    Frequently Asked Questions (FAQ) About Plague (Centers for Disease Control and Prevention)
    Plague (Johns Hopkins University, Center for Civilian Biodefense Strategies)
    Plague and Animals (National Center for Infectious Diseases)
    Plague: Epidemiology (Centers for Disease Control and Prevention)
    
    ★Organizations
    National Center for Infectious Diseases
    National Institute of Allergy and Infectious Diseases
    Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention)
    Also available in:  Spanish
    WHO/OMS: World Health Organization (World Health Organization)
    
    ★Statistics
    Plague (World Health Organization)
    Page last updated: 05 December 2002
    
    



    MEDLINEplus: Smallpox

    Contents of this page:
    News
    General/Overviews
    Alternative Therapy
    Clinical Trials
    Coping
    Pictures/Diagrams
    Prevention/Screening
    Research
    Specific Conditions/Aspects
    Law and Policy
    Organizations
    Statistics
    Children
    Teenagers
    Other Foreign Language
    Search MEDLINE for recent research articles on
    ・ Smallpox
    You may also be interested in these MEDLINEplus related pages:
    ・ Biodefense and BioterrorismInfectionsPoisoning, Toxicology, Environmental Health
    Latest News
    FDA Announces Smallpox Vaccine Guidance for Blood Industry ( 12/30/2002, Food and Drug Administration )
    Smallpox Shot Safer for Those Already Immunized (12/24/2002, Reuters Health)
    Researchers Develop Smallpox Vaccine Test (12/24/2002, Associated Press)
    Widespread Smallpox Shots Unwarranted (12/20/2002, Reuters Health)
    HHS and CDC Continuing to Educate Health Care Personnel and General Public About Smallpox ( 12/19/2002, Centers for Disease Control and Prevention )
    Protecting Americans: Smallpox Vaccination Program ( 12/13/2002, White House )
    More News on SmallpoxGeneral/Overviews
    Smallpox (World Health Organization)
    Also available in:  Spanish
    Smallpox (Centers for Disease Control and Prevention)
    Smallpox Overview (Centers for Disease Control and Prevention)
    Also available in:  Spanish
    What Is Smallpox? (Mayo Foundation for Medical Education and Research)
    
    ★Alternative Therapy
    Bioterrorism and CAM (Complementary and Alternative Medicine): What the Public Needs To Know (National Center for Complementary and Alternative Medicine)
    
    ★Clinical Trials
    ClinicalTrials.gov: Smallpox (National Institutes of Health)
    
    ★Coping
    Bioterrorism Concerns after September 11: Frequently Asked Questions (Johns Hopkins University, Center for Civilian Biodefense Strategies)
    
    ★Pictures/Diagrams
    Smallpox Images (Centers for Disease Control and Prevention)
    Vaccine Reaction Images (Centers for Disease Control and Prevention)
    
    ★Prevention/Screening
    Caring for the Smallpox Vaccination Site (Centers for Disease Control and Prevention)
    Frequently Asked Questions: Smallpox (White House)
    Information on Live Virus Vaccines and Vaccinia (Centers for Disease Control and Prevention)
    Also available in:  Spanish
    Protecting Americans: Smallpox Vaccination Program (White House)
    Smallpox and Vaccinia (National Center for Biotechnology Information)
    Smallpox Vaccine Information (National Network for Immunization Information)
    Smallpox Vaccine Overview (Centers for Disease Control and Prevention)
    Also available in:  SpanishResearch
    Developing New Smallpox Vaccines (Centers for Disease Control and Prevention)
    NIAID Study Results Support Diluting Smallpox Vaccine Stockpile to Stretch Supply (Dept. of Health and Human Services)
    
    ★Specific Conditions/Aspects
    FDA Announces Smallpox Vaccine Guidance for Blood Industry (Food and Drug Administration)
    Hearing on Smallpox (National Institute of Allergy and Infectious Diseases)
    Reactions after Smallpox Vaccination (Centers for Disease Control and Prevention)
    Also available in:  Spanish
    Smallpox Questions and Answers: The Disease and the Vaccine (Centers for Disease Control and Prevention)
    Smallpox Vaccination and the Patient with HIV/AIDS (Johns Hopkins University, Center for Civilian Biodefense Strategies)
    Smallpox: Frequently Asked Questions (American Academy of Pediatrics)
    Smallpox: Health Information for International Travel, 2001-2002 (Centers for Disease Control and Prevention)
    
    ★Law and Policy
    CDC's Smallpox Preparation and Response Activities (Centers for Disease Control and Prevention)
    Draft Supplemental Recommendations of the ACIP: Use of Smallpox (Vaccinia) Vaccine, June 2002 (Centers for Disease Control and Prevention)
    Medical Society Supports 'Ring Vaccination' in Case of Smallpox Outbreak (American Academy of Pediatrics)
    Smallpox Questions and Answers: Section 304 of the Homeland Security Act (Centers for Disease Control and Prevention)
    Summary of October 2002 ACIP Smallpox Vaccination Recommendations (Centers for Disease Control and Prevention)
    
    ★Organizations
    Johns Hopkins University, Center for Civilian Biodefense Strategies
    National Institute of Allergy and Infectious Diseases
    Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention)
    Also available in:  Spanish
    WHO/OMS: World Health Organization (World Health Organization)
    
    ★Statistics
    Smallpox Vaccine Adverse Event Rates (Centers for Disease Control and Prevention)
    
    ★Children
    What Is Smallpox? (Nemours Foundation)
    
    ★Teenagers
    What Is Smallpox? (Nemours Foundation)
    
    ★Other Foreign Language
    Aide-M駑oire sur la Variole (World Health Organization)
    Diagnostic de la Variole (World Health Organization)
    Questions/Responses sur la Variole (World Health Organization)
    Page last updated: 30 December 2002
    
    



    ●その他

    炭疽(そ)関連情報 ---各種資料やサイトリンク --- --- ---






    ●主要サイト

    国立感染症研究所・感染症情報センター

    IDWR 感染症の話

    エボラ出血熱[2000年33週(第33号)] 炭疽[1999年46週(第33号)] 天然痘[2001年40週(第40号)] 乳児ボツリヌス症[1999年47週(第34号)] ペスト[1999年43週(第30号)] ラッサ熱[2000年24週(第24号)]
    ●その他

    炭疽菌における薬剤耐性の現状[2001年11月12日 耐性菌 薬剤耐性菌情報]




    WHO

    WHO Bulletin/Biological Weapons
    Tuesday, July 06, 1999 (14:57)
    url: http://www.who.int/bulletin/editorials/issue2/biologicalweapons
    
    Responding to the deliberate use of biological agents and chemicals as weapons
    http://www.who.int/emc/deliberate_epi.html ; Friday, October 05, 2001 (14:48)
     --全文WHO's technical guide "Health Aspects of Biological and Chemical Weapons"[pdf]
     ---Frequently asked questions regarding the deliberate use of biological agents and chemicals as weapons
    
    ●各疾患
    Plague
    Haemorrhagic Fevers
    Ebola Haemorrhagic Fevers
    
    
    
    ●Anthrax
    Anthrax- WHO Recommended Surveillance Standards
    http://www.who.int/emc-documents/surveillance/docs/whocdscsrisr992.html/02Anthrax.htm
    2001 - Anthrax in the United States (State of Florida)[2001.10.10]
    http://www.who.int/disease-outbreak-news/n2001/october/10october2001.html
    Guidelines for the Surveillance and Control of Anthrax in Humans and Animals
    http://www.who.int/emc-documents/zoonoses/docs/whoemczdi986_nofigs.html
    Guidelines for the Surveillance and Control of Anthrax in Humans and Animals
    http://www.who.int/emc-documents/zoonoses/docs/whoemczdi986.html
    
    ●Tularemia
    
    
    



    FDA- CBER

    Countering Bioterrorism
    FAQs
    Meetings/Workshops
     ---December 6-7, 2000 ;概説と、各論題毎のPPT/Text
    ●Vaccines
    Anthrax
    Flu  Vaccineほか
    
    



    CDC

    Bioterrorism
    
    Anthrax
    Plague
    Smallpox
    Tularemia
    Botulism
    
    Ebola Hemorrhagic Fever
    
    
    
    CDC -Bioterrorism: Agents/Diseases

    This section includes disease/agent specific information pertaining to two basic categories--biological agents/diseases and chemical agents. As stated in the MMWR, April 21, 2000 / 49(RR04);1-14, "The public health infrastructure must be prepared to prevent illness and injury that would result from biological and chemical terrorism, especially a covert terrorist attack. As with emerging infectious diseases, early detection and control of biological and chemical attacks depends on a strong and flexible public health system at the local, state and federal levels. In addition, primary health-care providers throughout the United States must be vigilant because they will probably be the first to observe and report unusual illness or injuries."

    ■Biological Diseases
    ●Category A
    Bacillus anthracis (anthrax)
    Clostridium 
    botulinum toxin (botulism)
    Yersinia pestis 
    (plague)
    variola major (smallpox)
    Francisella tularensis (tularemia)
    Viral hemorrhagic fever
    ●Category B
    Coxiella burnetti (Q fever)
    Brucella species (brucellosis)
    Burkholderia mallei (glanders)
    ricin toxin from Ricinus communis (castor beans)
    epsilon toxin of Clostridium perfringens
    Staphylococcus enterotoxin B
    ●Category C
    Nipah virus
    hantaviruses
    tickborne hemorrhagic fever viruses
    tickborne encephalitis viruses
    yellow fever
    multidrug-resistant tuberculosis
    
    ■Chemical Agents
    ●Blister/Vesicants
    Distilled Mustard (HD)
    Lewisite (L)
    Mustard Gas (H)
    Nitrogen Mustard (HN-2)
    Phosgene Oxime (CX)
    Ethyldichloroarsine (ED)
    Lewisite 1 (L-1)
    Lewisite 1 (L-2)
    Lewisite 1 (L-3)
    Methyldichloroarsine (MD)
    Mustard/Lewisite (HL)
    Mustard/T
    Nitrogen Mustard (HN-1)
    Nitrogen Mustard (HN-3)
    Phenodichloroarsine (PD)
    Sesqui Mustard
    ●Blood
    Arsine (SA)
    Cyanogen Chloride (CK)
    Hydrogen Chloride
    Hydrogen Cyanide (AC)
    ●Choking/Lung/Pulmonary Damaging
    Chlorine (CL)
    Diphosgene (DP)
    Nitrogen Oxide (NO)
    Perflurorisobutylene (PHIB)
    Phosgene (CG)
    Red Phosphorous (RP)
    Sulfur Trioxide-Chlorosulfonic Acid (FS)
    Teflon and Perflurorisobutylene (PHIB)
    Titanium Tetrachloride (FM)
    Zinc Oxide (HC)
    ●Incapacitating
    BZ
    Canniboids
    Fentanyls
    LSD
    Phenothiazines
    ●Nerve
    Cyclohexyl Sarin (GF) Adobe
    GE
    Sarin (GB)
    Soman (GD)
    Tabun (GA)
    VE
    VG
    V-Gas
    VM
    VXRiot Control/Tear
    Bromobenzylcyanide (CA)
    Chloroacetophenone (CN)
    Chloropicrin (PS)
    CNB - (CN in Benzene and Carbon Tetrachloride)
    CNC - (CN in Chloroform)
    CNS - (CN and Chloropicrin in Chloroform)
    CR
    CS
    ●Vomiting
    Adamsite (DM)
    Diphenylchloroarsine (DA)
    Diphenylcyanoarsine (DC)
    ●Other Industrial Chemicals
    
    



    CDC Bioterrorism

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    Department of Health and Human Services - USA

     

    Department of Health and Human Services - USA
    Bullet Public Health Emergency Response  
    Bullet Addressing public concern about response to public health emergencies:Jeffrey P. Koplan, M.D., M.P.H. ,October 2, 2001

    Adobe PDF
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    Bullet
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    Bullet
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    Bullet
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    Bullet
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    Bullet
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    This page last reviewed:
    October 9, 2001
    FirstGov

    
    



    FDA -Bioterrorism

    http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html
    
    Bioterrorism
    General Information


    Public Health Initiatives/
    Actions/Preparedness

     

     Biological Agents

    Anthrax Information

    Anthrax Vaccine/Treatments

    Other Biological Agents

    In the News

    What's the Difference Between the Flu and Anthrax?
    Many illnesses have symptoms that can be called "flu-like." This chart compares flu symptoms with those for the three types of anthrax. More.

    How Should You Handle a Suspicious Letter?
    How do you identify a suspicious letter or package? What steps should you take if an envelope with powder spills on the surface or if there is a question of room contamination? This advisory from the Centers for Disease Control and Prevention explains. More.

    Should You Buy Cipro, Other Antibiotics from Online Sources?
    Reports of anthrax exposure have spawned numerous Websites and e-mail ads selling Cipro and other antibiotics. Are these sites safe to buy from? The Federal Trade Commission has the answer in a consumer alert that tells what you need to know before deciding to buy these products online. More.

    'Cyber-Letters' Issued to Websites Selling Unapproved Cipro
    Eleven foreign websites marketing ciprofloxacin in defiance of United States laws have received warnings from FDA. The warnings detail steps the agency is taking to protect Americans from potentially useless or harmful drugs.
    More.

    FDA Encourages Label Revisions for Two Anthrax Drugs
    To clarify that the antibiotics doxycycline and penicillin G procaine are both approved for treating all forms of anthrax infections, FDA has issued a notice urging drug companies to update labels on these drugs. More.




    ■その他

    AAFP Bioterrorism

    - http://www.aafp.org/x7406.xml; 米国家庭医学会 Updates - 他サイト情報 AAFP Resources - Key Links - リンク Education Literature Preparedness Patient Info Reporting Info - Other Resources - リンク














    [1147]天然痘ワクチン●製品smallpox vaccine(Dryvax[Wyeth])


     日本語版註)smallpox vaccine (Dryvax[Wyeth]) 天然痘ワクチン
     【別名】 【開発元】Wyeth  [DBR_ID]00569
     【化学名】Smallpox Vaccine, Dried, Calf Lymph Type
     【承認】FDA申請=、FDA承認=25-Oct-2002 ;【製剤】 【適応】Active immunization against smallpox disease 【製品情報】 【添付文書】http://www.fda.gov/cber/label/smalwye102502LB.pdf 【EU】 【日本】 【その他】Dryvaxは1944年に製造を開始していたもの。
    
    


    【日本語版コメント】
     現在天然痘ワクチンを供給しているメーカーは、以下の通り。
    Wyeth - http://www.vaccine-worldinfo.com/-Wyethワクチン製品サイト(要ID)
    Aventis Pasteur - アベンティスパスツール
    Acambis Inc.
    Baxter HealthcareはAcambisと提携。
     日本では、細菌製剤協会加盟ワクチンメーカーからは天然痘ワクチンの情報は公表されていない。厚生労働省平成15年度歳出概算要求では、天然痘ワクチン検定・保管施設関連予算は含まれている。 厚生科学審議会感染症分科会感染症部会
    大規模感染症事前対応専門委員会報告書
    [平成14年3月]や「国内の緊急テロ対策関係」ホームページで一応の対策が公開されている。
    <日本語版コメント用要約>
    ・生物テロに備えるため、天然痘ワクチンの接種が再開される。
    ・天然痘ワクチンはワクチニアウィルスを使用した生ワクチン。
    ・副作用が多く、初回接種で100万人に約1人が死亡している。
    ・ワクチンの有効性は証明されていないが、暴露後4日以内に接種すれば重症または致命
    的な天然痘は予防できる可能性がある。
     →詳細は参考資料●リソース:生物兵器に纏めた。
    



    FDA-CBER Licensed Product Information

     - http://www.fda.gov/cber/efoi/approve.htm; Last Updated: 1/3/2003 
     FDA-CBER[生物製剤]の承認品目リスト[主成分abc順]から抜粋した。
    
    

    ●Smallpox Vaccine, Dried, Calf Lymph Type

    Proper name: Smallpox Vaccine, Dried, Calf Lymph Type
    Tradename: Dryvax
    Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003
    Indication for Use: Active immunization against smallpox disease
    Approval Date: 10/25/2002
    Type of submission: Biologics license application supplement

    FDA-CBER:Product Approval Information - Dryvax

     - http://www.fda.gov/cber/products/smalwye102502.htm
    
    Proper name: Smallpox Vaccine, Dried, Calf Lymph Type
    Tradename: Dryvax
    Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003
    Indication for Use: Active immunization against smallpox disease
    Approval Date: 10/25/2002
    Type of submission: Biologics license application supplement 
    Approval Letter (Text) 
    Label (PDF) (Text) 
    Last Updated: 11/6/2002
    
    ●Acambis Says Early Smallpox Vaccine Results Encouraging[2002.9.3]
     - Wyeth-Ayerst began making DryVax, in 1944, but discontinued production in the
     mid-1980s after the World Health Assembly certified the world free of naturally
      occurring smallpox
    
    

    FDA-CBER Talkpapers

    
    FDA Announces Smallpox Vaccine Guidance for Blood Industry - 12/30/2002
    HHS May Acquire More Than 75 Million Doses of Smallpox Vaccine - 3/29/2002
    




    ●メーカーサイト〜天然痘

    AMERICAN HOME PRODUCTS SUBMITS PLAN TO PRODUCE SMALLPOX VACCINE[2001.10.26]
     -
    
    ●Baxter Healthcare Corporation
     -http://www.baxter.com/
    Improving and Creating Opportunities To Develop Vaccines against Bioterrorism
    Threats - An Industry Perspective
    [2003.1.30] - Baxter Confirms Role in Smallpox Vaccine Production[2001.11.28] ●Acambis Inc. -http://www.acambis.com/ Product: Smallpox vaccine ACAM1000 and ACAM2000



    ●一般情報〜天然痘ワクチン

    Smallpox Vaccine Stockpile[2002.3.29]
     -http://www.hhs.gov/news/speech/2002/020329.html; The Department of HEALTH AND HUMAN SERVICES
     HHSはAventis Pasteurの天然痘ワクチンの効果と安全性が実証され次第75〜90million
     dosesを発注予定。これは、Acambis Baxterから155 million doses 及びAcambisから
     54 million dosesを購入しようというわれわれの計画と食い違うわけではない。
     Acambisの天然痘ワクチンは次世代ワクチンだ。
    HHS AWARDS $428 MILLION CONTRACT TO PRODUCE SMALLPOX VACCINE: Acambis/Baxter
    will produce 155 million doses by end of 2002
    [2001.11.28] -http://www.hhs.gov/news/press/2001pres/20011128.html ●http://www.smallpox.gov/ -HHSは、2002.12一般向けに本サイトを開設。 ●Bioterrorism -Family physicians are the first line of defense against bioterrorism -http://www.aafp.org/btresponse.xml Smallpox vaccine resources available[2002.12] -http://www.aafp.org/fpr/20021200/4.html FDA-CBER: Smallpox vaccine -http://www.fda.gov/cber/vaccine/smallpox.htm CDC -Hospital Smallpox Vaccination Monitoring System (HSVMS) - http://www.bt.cdc.gov/agent/smallpox/vaccination/hsvms Evaluating Patients for Smallpox (CDC) - http://www.cdc.gov/nip/smallpox/Providers.htm CDC Smallpox Resources - http://www.cdc.gov/nip/smallpox/



    ■天然痘 smallpox

    ●WHO/OMS: Search - 天然痘 smallpox

    WHO-CSR[Communicable Disease Surveillance and Response]
     -http://www.who.int/csr/en/
    WHO-CSR-Disease
     -http://www.who.int/entity/csr/disease/en
    WHO-CSR-Disease: Smallpox -http://www.who.int/entity/csr/disease/smallpox/en
    
    ★WHO- Disease Outbreak News: Smallpox vaccine - accidental exposure -http://www.who.int/disease-outbreak-news/disease/B03.htm
    
    ★WHO Health Topics: Smallpox -http://www.who.int/health_topics/smallpox/en
    
    WHO Fact Sheet: Smallpox[October 2001]
     - http://www.who.int/emc/diseases/smallpox/factsheet.html
    
    ★WHO: Smallpox vaccine
     - www.who.int/vaccines/en/smallpox.shtml
    
    ★WHO: Smallpox FAQ and fact sheetWHO: Updated Guidance on Smallpox Vaccination
    
    ●関連リンク
    CDC Public Health Emergency Preparedness & Response web site
    Useful Links for Health Effects from Chemical and Biological Agents
    WHO: Responding to deliberate use
    WHO: Health Aspects of Biological and Chemical Weapons
    WHO: AMRO/PAHO - Consultation Meeting on Bioterrorism
    US FDA: Bioterrorism Information
    Global Disaster Information Network
    
    
    
    
    AAFP Clinical Recommendations for Immunizations

    - http://www.aafp.org/x10631.xml ;米国家庭医学会 Statement on the Federal Smallpox Vaccination Program Announced by the President on December 13, 2002 Smallpox Immunization
    MEDLINEplus: Smallpox

    Contents of this page: News General/Overviews Alternative Therapy Clinical Trials Pictures/Diagrams Prevention/Screening Research Specific Conditions/Aspects Law and Policy Organizations Statistics Children Teenagers Other Foreign Language Search MEDLINE for recent research articles on ・ Smallpox You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismInfectionsPoisoning, Toxicology, Environmental HealthLatest News Smallpox Vaccinations Show No Problems Yet (02/07/2003, United Press International) CDC Chief: Bioterror Threat Remains Real (01/30/2003, Associated Press) Ohio Docs Learn from Smallpox "False Alarm" (01/29/2003, Reuters Health) Smallpox Vaccine Shipment Numbers (01/27/2003, Centers for Disease Control and Prevention) CDC Begins Shipping Smallpox Vaccine to the States (01/22/2003, Centers for Disease Control and Prevention) Smallpox Vaccinations: People with Cancer Could Have Problems (01/13/2003, American Cancer Society) More News on SmallpoxGeneral/Overviews Smallpox (World Health Organization) Also available in: Spanish Smallpox Overview (Centers for Disease Control and Prevention) Also available in: Spanish Smallpox Questions and Answers: The Disease and the Vaccine (Centers for Disease Control and Prevention) What Is Smallpox? (Mayo Foundation for Medical Education and Research) ●Alternative Therapy Bioterrorism and CAM (Complementary and Alternative Medicine): What the Public Needs To Know (National Center for Complementary and Alternative Medicine) ●Clinical Trials ClinicalTrials.gov: Smallpox (National Institutes of Health) ●Pictures/Diagrams Smallpox Images (Centers for Disease Control and Prevention) Vaccine Reaction Images (Centers for Disease Control and Prevention) ●Prevention/Screening Caring for the Smallpox Vaccination Site (Centers for Disease Control and Prevention) Also available in: Spanish Frequently Asked Questions: Smallpox (White House) Information on Live Virus Vaccines and Vaccinia (Centers for Disease Control and Prevention) Also available in: Spanish Protecting Americans: Smallpox Vaccination Program (White House) Reactions after Smallpox Vaccination (Centers for Disease Control and Prevention) Also available in: Spanish Smallpox and Vaccinia (National Center for Biotechnology Information) Smallpox Vaccination: An Important Decision (Centers for Disease Control and Prevention) Also available in: Spanish Smallpox Vaccine Information (National Network for Immunization Information) Smallpox Vaccine Overview (Centers for Disease Control and Prevention) Also available in: Spanish Smallpox Vaccines Questions and Answers (Food and Drug Administration) Someone You Are Close to Is Getting the Vaccine: What You Should Know and Do (Centers for Disease Control and Prevention) Also available in: SpanishResearch NIAID Study Results Support Diluting Smallpox Vaccine Stockpile to Stretch Supply (Dept. of Health and Human Services) Smallpox Vaccinations: People with Cancer Could Have Problems (American Cancer Society) ●Specific Conditions/Aspects FDA Announces Smallpox Vaccine Guidance for Blood Industry (Food and Drug Administration) Smallpox Vaccination and the Patient with HIV/AIDS (Johns Hopkins University, Center for Civilian Biodefense Strategies) Smallpox: Health Information for International Travel, 2001-2002 (Centers for Disease Control and Prevention) ●Law and Policy CDC's Smallpox Preparation and Response Activities (Centers for Disease Control and Prevention) Medical Society Supports 'Ring Vaccination' in Case of Smallpox Outbreak (American Academy of Pediatrics) Smallpox Questions and Answers: Section 304 of the Homeland Security Act (Centers for Disease Control and Prevention) Summary of October 2002 ACIP Smallpox Vaccination Recommendations (Centers for Disease Control and Prevention) ●Organizations Johns Hopkins University, Center for Civilian Biodefense Strategies National Institute of Allergy and Infectious Diseases Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention) Also available in: Spanish WHO/OMS: World Health Organization (World Health Organization) ●Statistics Smallpox Vaccination Report (Centers for Disease Control and Prevention) Smallpox Vaccine Adverse Event Rates (Centers for Disease Control and Prevention) Also available in: SpanishChildren What Is Smallpox? (Nemours Foundation) ●Teenagers What Is Smallpox? (Nemours Foundation) ●Other Foreign Language Aide-M駑oire sur la Variole (World Health Organization) Questions/R駱onses sur la Variole (World Health Organization) Page last updated: 08 February 2003








    [1494]●製品 炭疽に対する沈降炭疽病ワクチンAnthrax Vaccine Adsorbed(BioThrax[Emergent BioDefense Operations Lansing LLC])
    吸入炭疽病治療薬炭疽病免疫グロブリンAnthrax Immune Globulin Intravenous (Human)(Anthrasil[Emergent BioSolutions Inc])



     日本語版註)炭疽に対する沈降炭疽病ワクチンAnthrax Vaccine Adsorbed(BioThrax[Emergent BioDefense Operations Lansing LLC])
     【別名】 【開発元】BioPort Corpは1998年創立→2004年Emergent BioSolutions Incに社名変更(子会社Emergent BioDefense Operations Lansing LLC)  [DBR_ID]
     【化学名】BioThrax (Anthrax Vaccine Adsorbed) is a sterile, milky-white suspension for intramuscular or subcutaneous injections made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. The production cultures are grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins, inorganic salts, and sugars. The final product, prepared from the sterile filtrate culture fluid contains proteins, including the 83kDa protective antigen (PA) protein, released during the growth period and contains no dead or live bacteria. The final product is formulated to contain 1.2 mg/mL aluminum, added as aluminum hydroxide in 0.85% sodium chloride. The final product is formulated to contain 25 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde, added as preservatives.
     【承認〜保管期限18ヵ月】FDA承認=31-Jan-2002、米国発売(BioThraxは、1970年に炭疽菌の暴露に高度なリスクを持つ者に対する予防ワクチンとして承認されている。) to Bioport Corporation;
     【承認〜保管期限36ヵ月】FDA承認=27-Apr-2005;to BioPort Corporation
     【承認〜皮下注→筋注;間隔0,2,4週&6,12,18ヵ月→0,4週&6,12,18ヵ月】FDA承認=11-Nov-2008;
     【承認〜投与スケジュール5回0,1,6,12,18ヵ月with annual booster→3回0,1,6ヵ月with boostersその後12,18ヵ月、それからannual boosters】FDA承認=17-May-2012;to Emergent BioDefense Operations Lansing Inc.
     【承認〜Bacillus anthracis exposureを含める】FDA承認=23-Nov-2015;
     【製剤】BioThrax is supplied in 5 mL multidose vials containing ten 0.5 mL doses of Anthrax Vaccine Adsorbed.  【適応】(18〜65歳の炭疽菌の暴露が疑われる者もしくは暴露が確定した者の炭疽病予防) For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.
    BioThrax is approved for:
    1. Pre-exposure prophylaxis of disease in persons at high risk of exposure.
    2. Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. 【用法用量】筋注または皮下注、各0.5ml。 暴露前予防には、Primary Seriesとして0,1,6ヵ月目に筋注。 Booster SeriesではPrimary Series完了後12ヵ月間隔後に6,12ヵ月目に筋注。
    暴露後予防には、Primary Seriesとして0,2,4週目に抗菌剤と共に皮下注。
     【作用】Anthrax is a zoonotic disease caused by the Gram-positive, spore-forming bacterium Bacillus anthracis. BioThrax induces antibodies raised against PA that may contribute to protection by neutralizing the activities of the cytotoxic lethal toxin and edema toxin of Bacillus anthracis.3 Bacillus anthracis proteins other than PA may be present in BioThrax, but their contribution to protection has not been determined. 【特徴】 
     【製品情報】www.biothrax.com 【添付文書】BioThrax-pi
     【提携】 【EU】 
     【日本】未開発 【その他】BioThrax売上2016年は$237M



     日本語版註)吸入炭疽病治療薬炭疽病免疫グロブリンAnthrax Immune Globulin Intravenous (Human)(Anthrasil[Emergent BioSolutions Inc])
     【別名】 【開発元】創製Cangene Corporation[加]2014年2月Emergent BioSolutions Incに買収  [DBR_ID]
     【化学名】ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax (Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method. The source plasma is tested by FDA licensed nucleic acid testing (NAT) for human immunodeficiency virus-1 (HIV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV). Plasma also was tested by in-process NAT for hepatitis A virus (HAV) and parvovirus B19 (B19) via minipool testing; the limit for B19 in the manufacturing pool is set not to exceed 104 International Units of B19 DNA per mL.
     【承認】FDA承認=24-Mar-2015、米国発売 ;
     【製剤】Each vial of ANTHRASIL contains a minimum potency of ≧60 units per vial. ANTHRASIL, Anthrax Immune Globulin Intravenous (Human), is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracis lethal and edema toxins. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative.
     【適応】(吸入炭疽病治療) Indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs 【用法用量】17歳以上の成人には7バイアル(420単位)。初回30分で0.5ml/分静注。 次回30分で1ml/分静注。 最大2ml/分静注。 小児1-16歳には1-7 vials (60-420単位)。初回30分で0.01ml/kg/分静注。 次回30分で0.02ml/kg/分静注。 最大0.04ml/kg/分静注。
     【作用】The polyclonal immune globulin G in ANTHRASIL is a passive immunizing agent that neutralizes anthrax toxin. ANTHRASIL binds to protective antigen (PA) to prevent PA mediated cellular entry of anthrax edema factor and lethal factor. ANTHRASIL is administered in combination with appropriate antibiotic therapy as the product itself is not known to have direct antibacterial activity against anthrax bacteria, which otherwise may continue to grow and product anthrax toxins. 【特徴】 
     【臨床成績】同剤の有効性は、ヒトでの臨床試験は倫理的に困難なため、動物試験(ウサギおよびサル)においてプラセボ対照比較試験が実施された。Anthrasil投与群でプラセボ群との比較、Anthrasilおよび抗生物質との併用群と抗生物質単剤投与群との比較で、Anthrasil投与群ではいずれも生存率を延長させたことが示された。この動物試験の結果により、同剤は、吸入炭疽病患者にもベネフィットがあると考えるのは合理的とされた。 
     【副作用】安全性は、74例の健常人で検証された。主な副作用は、頭痛、背痛、悪心、注射部位疼痛および腫脹など。 
     【添付文書】Anthrasil-pi
     【提携】 【EU】 
     【日本】未開発 【その他】Anthrasilは吸入炭疽による毒血症治療薬としてFDA承認された唯一のポリクロナル抗体だが、炭疽治療薬のモノクロナル抗体ラキシバクマブRaxibacumab(ABthrax[GSK])もFDA承認を受けている。 また2016年3月21日に吸入炭疽の予防・治療Antitoxinのモノクロナル抗体Obiltoxaximab(Anthim注[Elusys Therapeutics, Inc.])がFDA承認された。
    US Pharmacopeial Commission
    AMA: United States Adopted Names
    BIAM
     --- BIAM -ABC順|BIAM -会社順
    NLM: MeSH HOme
     ---MeSH Online search
    
    
    



    【日本語版コメント1494〜炭疽に対するBioThraxとAnthrasil/2016.05.09】
    炭疽菌は、その胞子は破壊しにくく、空中に容易に散布が可能なことからバイオテロリズムの道具として使用される恐れがある。2001年9月米国で、放送局や一部連邦議会議員に対して、郵便で炭疽菌が送付され、5名の死亡者、10名以上の負傷者を生んだバイオテロ事件が発生し、米国社会を大きく揺るがし、炭疽菌について世界中の注目を集めた。
    現在日本で「炭疽」の適応を取得しているのは、アンピシリン、ベンジルペニシリンカリウム、テトラサイクリン塩酸塩、デメチルクロルテトラサイクリン塩酸塩、ミノサイクリン塩酸塩、ドキシサイクリン塩酸塩、シプロフロキサシン、ノルフロキサシン、レボフロキサシン、トスフロキサシントシル酸塩。
     吸入炭疽病治療薬炭疽病免疫グロブリンAnthrasilは吸入炭疽による毒血症治療薬としてFDA承認された唯一のポリクロナル抗体だが、炭疽治療薬のモノクロナル抗体ラキシバクマブRaxibacumab(ABthrax[GSK])もFDA承認を受けている。 また2016年3月21日に吸入炭疽の予防・治療Antitoxinのモノクロナル抗体Obiltoxaximab(Anthim注[Elusys Therapeutics, Inc.])がFDA承認された。  炭疽に対する沈降炭疽病ワクチンBioThraxは1970年にFDA承認されている古い薬剤だが、売上2016年は$237M
     →詳細は参考資料●MLリソース:生物兵器に纏めた。
    



    ●承認データ:FDA

    FDA Newsroom - FDA Press Releases FDA approves vaccine for use after known or suspected anthrax exposure[November 23, 2015] - BioThrax (Anthrax Vaccine Adsorbed) a new indication BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure. by Emergent BioDefense Operations Lansing LLC, based in Lansing, Michigan. FDA approves treatment for inhalation anthrax[March 25, 2015] - Anthrasil, Anthrax Immune Globulin Intravenous (Human), by Cangene Corporation, based in Winnipeg, Canada ●Index to Drug-Specific Information
    [FDA-CBER]Vaccines, Blood & Biologics - Vaccines - Approved Products

    Biothrax STN: BL 103821 Proper Name: Anthrax Vaccine Adsorbed Tradename: Biothrax Manufacturer: Emergent BioDefense Operations Lansing LLC Indication: For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure. Product Information Package Insert and Information for Patients - Biothrax (PDF - 363KB) Supporting Documents November 23, 2015 Approval Letter - Biothrax (PDF - 42KB) To include post-exposure prophylaxis (PEP) of disease resulting from suspected or confirmed Bacillus anthracis exposure, when combined with the recommended course of antimicrobial therapy in persons 18 through 65 years of age. November 11, 2015 Summary Basis for Regulatory Action - BioThrax (PDF - 159KB) May 17, 2012 Summary Basis for Regulatory Action - BioThrax (PDF - 152KB) May 17, 2012 Approval Letter - BioThrax To change the dosing schedule from a five-dose primary schedule at 0, 1, 6, 12, 18 months with annual booster to a three-dose primary schedule at 0, 1, 6 months. September 16, 2010 Approval Letter - BioThrax [ARCHIVED] Patient Package Insert (PPI). December 11, 2008 Approval Letter Updated to to include a change in schedule from 0, 2, 4 weeks and 6, 12 and 18 months to 0, 4 weeks, and 6, 12, and 18 months, and a change in route of administration from subcutaneous to intramuscular. January 31, 2002 Approval Letter April 27, 2005 Approval Letter [ARCHIVED] Updated to include an extension of dating to 36 months has been approved. Related Information FDA Online Label Repository Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved. ■AnthraxApproval History, Letters, Reviews, and Related Documents - Anthrasil[Updated: 07/13/2016 ]
    [FDA-CBER]Vaccines, Blood & Biologics - Blood & Blood Products - Approved Products - Licensed Products (BLAs) - Fractionated Plasma Products

    ANTHRASIL STN: 125562 Proper Name: Anthrax Immune Globulin Intravenous (Human) Tradename: ANTHRASIL Manufacturer: Cangene Corporation Indication: Indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs Product Information Package Insert and Patient Information - ANTHRASIL (PDF - 348KB) Supporting Documents March 24, 2015 Approval Letter - ANTHRASIL (PDF - 88KB) March 25, 2015 Summary Basis for Regulatory Action - Anthrasil (PDF - 1MB) Approval History, Letters, Reviews, and Related Documents - Anthrasil Related Information FDA approves treatment for inhalation anthrax








    [1116-17]●製品anthrax vaccine (Biothrax [BioPort Corp]) 炭疽菌ワクチン


     日本語版註)anthrax vaccine (Biothrax [BioPort Corp]) 炭疽菌ワクチン
     【別名】 【開発元】BioPort Corpは1998年創立→2004年Emergent BioSolutions Incに社名変更  [DBR_ID]
     【化学名】Anthrax Vaccine Adsorbed, (BioThrax) is a sterile, milky-white suspension (when mixed) made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis.
     【承認】FDA承認=31-Jan-2001 ;【製剤】BioThrax is supplied in 5 mL multidose vials containing ten 0.5 mL doses 【適応】BioThrax is indicated for the active immunization against Bacillus anthracis of individuals between 18 and 65 years of age who come in contact with animal products such as hides, hair or bones that come from anthrax endemic areas, and that may be contaminated with Bacillus anthracis spores. BioThrax is also indicated for individuals at high risk of exposure to Bacillus anthracis spores such as veterinarians, laboratory workers and others whose occupation may involve handling potentially infected animals or other contaminated materials. 【用法用量】[Primary series]0,1,6ヵ月目に0.5 mLを筋注 [Booster doses]primary series後、1年間経過後12,18ヵ月目に0.5 mLを筋注
     【作用】Anthrax is a zoonotic disease caused by the Gram-positive, spore-forming bacterium Bacillus anthracis. Although an immune correlate of protection is unknown, BioThrax induces antibodies raised against PA, which may contribute to protection by neutralizing the activities of the cytotoxic lethal toxin and edema toxin of Bacillus anthracis. Bacillus anthracis proteins other than PA may be present in BioThrax, but their contribution to protection has not been determined. 【特徴】 
     【製品情報】www.biothrax.com 【添付文書】Biothrax-PI
     【EU】 【日本】未開発 【その他】
    
    



    FDA-CBER Vaccines Approved Products

    Biothrax

    STN: BL 103821
    Proper Name: Anthrax Vaccine Adsorbed
    Tradename: Biothrax
    Manufacturer: Emergent BioDefense Operations Lansing Inc., License #1755
    Indication:

    • For the active immunization for the prevention of disease caused by Bacillus anthracis in persons between 18 and 65 years of age at high risk of exposure.

    Product Information

    Supporting Documents


    Anthrax Vaccine Adsorbed

    Proper name: Anthrax Vaccine Adsorbed
    Tradename: Biothrax
    Manufacturer: BioPort Corp, Lansing, MI, License #1260
    Manufacturing change: Hollister-Stier as contract manufacturer for filling
    Approval Date: 1/31/2002
    Type of submission: Biologics license application supplement

    Proper name: Anthrax Vaccine Adsorbed
    Tradename: Biothrax
    Manufacturer: BioPort Corp, Lansing, MI, License #1260
    Labeling change: Update of labeling
    Approval Date: 1/31/2002
    Type of submission: Biologics license application supplement

    FDA-CBER:Product Approval Information - Biothrax

    Proper name: Anthrax Vaccine Adsorbed Tradename: Biothrax Manufacturer: BioPort Corp, Lansing, MI, License #1260 Manufacturing change: Hollister-Stier as contract manufacturer for filling Approval Date: 1/31/2002 Type of submission: Biologics license application supplement Approval Letter (PDF), (Text) Talkpaper Last Updated: 1/31/2002
    FDA-CBER:Product Approval Information - Biothrax

    -http://www.fda.gov/cber/products/biopava0131022.htm Proper name: Anthrax Vaccine Adsorbed Tradename: Biothrax Manufacturer: BioPort Corp, Lansing, MI, License #1260 Labeling change: Update of labeling Approval Date: 1/31/2002 Type of submission: Biologics license application supplement Approval Letter (PDF), (Text) Label (PDF) Last Updated: 1/31/2002




    FDA CBER - Anthrax Vaccine

    http://www.fda.gov/cber/vaccine/anthrax.htm

    Anthrax is an infectious disease caused by spores of the bacterium, Bacillus anthracis. The B. anthracis spores are highly resistant to inactivation and may be present in the soil, for example, for decades, occasionally infecting grazing animals that ingest the spores. Goats, sheep and cattle are examples of animals that may become infected. Human infection may occur by three routes of exposure to anthrax spores: cutaneous (through the skin), gastrointestinal (by ingestion), and pulmonary (inhalation). In North America, human cases of anthrax are infrequent. However, the United States military views anthrax as a potential biological terrorism threat because the spores are so resistant to destruction and can be easily spread by release in the air. The development of anthrax as a biological weapon by several foreign countries has been documented.

    Human anthrax cases can occur in 3 forms. Cutaneous infection is the most common manifestation of anthrax in humans, accounting for more than 95 percent of cases. Ingestion of undercooked or raw, infected meat can cause gastrointestinal anthrax infection. Breathing in airborne spores may lead to inhalation anthrax. The mortality rates from anthrax vary, depending on exposure, and are approximately 20% for cutaneous anthrax without antibiotics and 25 - 75% for gastrointestinal anthrax; inhalation anthrax has a fatality rate that is 80% or higher. Cutaneous anthrax can usually be successfully treated with antibiotics. An efficacy supplement for Ciprofloxacin was approved on August 30, 2000 for inhalation anthrax (post-exposure).

    The only known effective prevention against anthrax is the anthrax vaccine. The vaccine was developed from an attenuated strain of B. anthracis. The vaccine derives from the cell-free culture filtrate of this strain and, in its final formulation, is adsorbed onto an aluminum salt. A well controlled clinical trial of anthrax vaccine was conducted in U.S. mill workers processing imported animal hair. During the trial, 26 cases of anthrax were reported at the mills - five inhalation and 21 cutaneous cases. Of the five inhalation cases, two individuals had received the placebo, while three individuals were in the observational group. Four of the five people who developed inhalation anthrax died. No cases of inhalation anthrax occurred in anthrax vaccine recipients. Based upon a comparison between the anthrax vaccine and placebo recipients, the authors calculated a vaccine efficacy level of 92.5 percent.

    The anthrax vaccine, termed Anthrax Vaccine Adsorbed (or AVA) is recommended for individuals who may come in contact with animal products that may be contaminated with Bacillus anthracis spores and for individuals engaged in diagnostic or investigational activities which may bring them in contact with Bacillus anthracis spores. It is also recommended for persons at high risk, such as veterinarians and others handling potentially infected animals. There is only a single anthrax vaccine licensed in the U.S.; the vaccine is manufactured by Bioport, located in Lansing, Michigan.

    Because of biological warfare threats, the miltary has had an active vaccination program against anthrax.

     

    ●References Dixon, TC, et al. "Anthrax." New England Journal of Medicine, 341(11), 1999, pp. 815-826. "Recommendations of the Advisory Committee on Immunization Practices: Use of Anthrax Vaccine in the United States." Morbidity and Mortality Weekly Report, Vol. 49(rr15), December 15, 2000, pp.1-20. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm ●Related Information FDA Statement - Confirmatory anthrax testing at all its buildings show buildings are negative for anthrax - 11/5/2001 Federal Register Notice - Prescription Drug Products; Doxycycline and Penicillin G Procaine Administration for Inhalational Anthrax (Post-Exposure) Guidance for Industry - Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Possible Exposure to Anthrax HHS Biological Incidents: Preparedness and Response CDC Website with Anthrax Information. http://www.cdc.gov/ncidod/dbmd/diseaseinfo/anthrax_g.htm Dr. Susan Ellenberg's Testimony about Anthrax. http://www.fda.gov/ola/1999/anthrax.html Dr. Kathryn Zoon's Testimony about Anthrax Vaccine. http://www.fda.gov/ola/2000/anthraxvaccine2.html FDA Written Statement Regarding Anthrax Vaccine http://www.fda.gov/ola/2000/anthraxvaccine.html Questions and Answers About Anthrax Prevention and Treatment - HHS News http://www.hhs.gov/news/press/2001pres/20011010a.html JAMA articles available to public that address biological weapons http://www.ama-assn.org/ama/pub/article/2403-5360.html Last Updated: 11/5/2001




    FDA-CBER Talkpapers

    
    FDA Statement - Confirmatory anthrax testing at all its buildings show buildings
    are negative for anthrax
    - 11/5/2001 Questions and Answers About Anthrax Prevention and Treatment - HHS News - 10/10/2001
    BioPort Corp

    同社は、ミシガン州で70年間ワクチンなどの製造に従事してきたMichigan Biologic P roducts Institute を母体として、1998年設立。  ホームページには、ニュースリリース、製品情報、ファクトデータなどが公開 Anthrax vaccine -Biotherax




    ■一般情報

    バイオテロ対策「天然痘ワクチン250万人分備蓄へ」 厚生労働省[薬事日報 01.11.21]

    【国内メーカーの製造体制はゼロ】

     厚生労働省はバイオテロ対策として天然痘ワクチン二五〇万人分を早急に備蓄する方針を固め、九億円余りを補正予算に盛り込んだ。厚生労働省は予算成立以前から国内ワクチンメーカーに製造可能か打診していた模様。しかし、十六日午前の参院本会議で補正予算は成立したものの、多くの国内メーカーの製造体制はゼロに等しい状況だ。
    --------------------------------------------------------------------------------
     国内ワクチンメーカーは二十年以上前に天然痘ワクチンの製造を中止している。たとえ厚生労働省から正式に発注されたとしても、現状では製造設備が全く整っていない。注文を受けてから設備を早急に整えなければならないからだ。さらに、製造承認と許可をすでに取り下げてしまっているメーカーも多い。

     近藤事務次官は十五日の定例会見で、先日の米国トンプソン厚生長官との会合において天然痘テロの対応についても話し合ったことを明らかにした。米国政府も天然痘テロを最も警戒しており、来年中に三億人分のワクチンを用意する方針で医薬品メーカーと価格を含めた最終的な交渉を行っているという。三億人分という数字は米国の人口を超える規模であり、カナダやメキシコなど他国への供給分も含めていると考えられる。なお、米国政府が現在備蓄しているワクチンは一四〇〇万人分しかない。緊急時に薄めることで、より多くの人に投与するための希釈試験も行われている。

     これに対して、日本では二五〇万人分の備蓄計画を発表しているが、それを国内メーカーに発注するのか、海外製品を輸入するのかはまだ決まっていない。今回の備蓄を一時的な措置と捉えるか、あるいは今後もバイオテロを想定した継続的な買い上げが続くと捉えるかによって対応が変わる。備蓄を継続するのであれば、買い上げ需要を受けて国内ワクチンメーカーも製造体制を整えることができるが、もし一時的なものであれば海外から購入するということも考えられる。

     現在、世界では、フランスのアベンティス、パスツールなどが僅かに天然痘ワクチンを製造している。しかし、国民レベルでの需要に耐えられるほどの大量生産はしていない。英国グラクソ・スミスクラインは十月二十五日、米国政府に対して「現在は天然痘ワクチンを生産していないが、必要があればすぐに生産する」という製造提案書を提出した。海外では、グラクソ・スミスクライン、メルク、バクスターの三社が受注することになりそうだと報じられている。

     二十年以上前に世界的に使用されていたのは「リスター株」と呼ばれ、直接ウシで株を培養するものだった。今回米国では、組織培養という新しい方法でワクチンを作るという。

     国内では二十数年前のワクチン製造末期、千葉県血清研究所によって副作用の少ない「橋爪株」が開発された。しかも橋爪株はガラス瓶の中で組織培養できるために衛生的。しかし開発成功直後に予防接種が廃止され、さらに法的にも予防接種が廃止されるという事態に見舞われ、橋爪株は陽の目を見なかった。同研究所は天然痘ワクチンが製造されていた当時、世界で唯一細胞培養の技術を保有していた。その高い技術から、WHOによる天然痘撲滅宣言が出された後も製造承認を取り下げなかった。

     橋爪株は現在でも使用可能。今では専用の製造設備を有していないが、技術的には既存の施設でも製造可能だという。千葉県血清研究所は本紙の取材に対し、「天然痘ワクチンの製造に対応できるよう現在準備を進めてる」と答えた。仮に政府の備蓄目標である二五〇万人分を製造する場合、従来の製造方法では着手から六カ月余りで製造できる見通しである。十六日午後の段階ではまだ正式な注文は受けていない。

     他の国内ワクチンメーカーへの取材では「厚生労働省にはもう作れないと回答した」「現状では設備面でも法的な面でも整っていないため作れないが、状況が整備されれば協力したい」などの声が聞かれた。国内メーカーに製造を求めるのならば、予算以外にも法的整備も含めた早急な枠組み作りが必要になっている。

    
    
    
    
    ●各サイトの炭疽菌情報

    Anthrax as a Biological Weapon, 2002: Updated Recommendations for Management - http://jama.ama-assn.org/issues/v287n17/ffull/jst20007.html; JAMA Consensus Statement, May 1, 2002 MMWR: Evaluation of Postexposure Antibiotic Prophylaxis to Prevent Anthrax - http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5103a4.htm Treatment Options for Exposure to Anthrax (CDC) - http://www.sph.unc.edu/about/webcasts/2001-12-27_post/ Additional Options for Preventive Treatment for Those Exposed to Inhalational Anthrax (HHS) - http://www.bt.cdc.gov/DocumentsApp/Anthrax/12182001/hhs12182001.asp MMWR Anthrax and Bioterrorism Information - http://www.cdc.gov/mmwr/indexbt.html








    炭疽菌治療薬●[1116-17]製品ciproflaxacin (Cipro [Bayer])


     日本語版註)ciproflaxacin (Cipro [Bayer])
     【別名】 【開発元】Bayer  [DBR_ID]
     【化学名】
     【承認】FDA申請=、FDA承認=31-Aug-01 ;【適応】 【製品情報】http://www.ciprousa.com/ 【添付文書】http://www.ciprousa.com/utilities/pi.asp 【その他】CiproR was first approved in the US in l987. It has been used in more than 100 million patients in the US, and approximately 250 million patients worldwide. It is now approved for a total of 14 indications. These include a number of serious infections such as lower respiratory tract, intra-abdominal, typhoid fever, bone, and joint infections, in addition to the newly-approved indication, inhalational anthrax (post-exposure).




    【日本語版コメント】
     前号に続くバイオテロの記事。 コメントも今回は追加
    ・NEW England J Med 01.11.29号で炭疽に関する最新情報を網羅的に紹介(http://nejm.org/specialnotice/)
    ・FDA CBER - Anthrax Vaccine(http://www.fda.gov/cber/vaccine/anthrax.htm)では、Bioport社製炭疽ワクチンだけでなく、他の治療薬情報も纏め。
    ・FDA -Bioterrorism(http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html)はFDAのバイオテロ関連データ集。(Cipro,炭疽ワクチン、ドキシサイクリン情報含む)
    ・FDA CDER-Drug Information - Cipro (Ciprofloxacin Hydrochloride) for Inhalation Anthrax (http://www.fda.gov/cder/drug/infopage/cipro/)には、01.8.31承認の炭疽菌の適応追加だけでなく、フルオロキノロンのデータもある。 なお10月にはドキシサイクリンの炭疽菌への適応追加がFDA承認された。
    ・01.11.6 米国ロシュ・ダイアグノスティックスは、炭疽菌検出用DNA検査キットの開発に成功したと発表。同キットでは一時間以内で炭疽菌を検出でき、各検査機関に無料提供することも発表。
    ・米国政府は、天然痘テロを最も警戒しており、2002年中に三億人分のワクチンを用意する方針(現在備蓄1400万人分)。日本も01.11.16に250万人分備蓄の補正予算成立
    ・バイエル薬品、第一製薬、大日本製薬、富山化学工業らは、現在販売中の合成抗菌剤について、炭疽に対する適応拡大を11月2日までにそれぞれ申請したとのこと。



    ●承認データ:FDA
    	
    情報ソース●CDER New and Generic Drug Approvals: 1998-2001 : C Cipro HC Otic/Ciprofloxacin Hydrochloride & Hydrocortisone Otic Suspension,Rx Bayer Corporation Application # =NDA 20-805 Approval Date =2/10/98 Letter Posted =1/7/99 Label Posted =1/7/99 Review Posted =1/7/99 Cipro (Ciprofloxacin Hydrochloride) Tablets, IV Solution, IV in 5% Dextrose, IV in 0.9% Saline, & Oral Suspension, Rx Bayer Corporation, Pharmaceutical Division Application # =NDA 19-537/S038, 19-847/S024, 19-857/S027, 19-858/S021, 20-780/S008 Approval Date =8/30/00 Letter Posted =9/7/00 Label Posted =9/7/00 Review Posted =10/16/01 Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, Rx Tentatively Approved 5/30/01 Geneva Pharmaceuticals, Inc. Application # =ANDA 75-939 Approval Date =5/30/01 Letter Posted =6/5/01 Label Posted = Review Posted = Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, Rx Tentatively Approved 8/31/01 Genpharm Inc. Application # =ANDA 75-817 Approval Date =8/31/01 Letter Posted = Label Posted = Review Posted = Ciprofloxacin Tablets USP, 250 mg, 500, and 750 mg, Rx Tentatively Approved 3/30/01 Ranbaxy Pharmaceuticals Inc. Application # =ANDA 75-747 Approval Date =3/30/01 Letter Posted =3/30/01 Label Posted = Review Posted = Ciprofloxacin Tablets USP, 250, 500 & 750 mg, Rx Tentatively Approved 7/18/01 Mylan Pharmaceuticals, Inc. Application # =ANDA 75-685 Approval Date =7/18/01 Letter Posted = Label Posted = Review Posted = Ciprofloxacin Tablets USP,750 mg, Rx Tentatively Approved 3/30/00 Mylan Pharmaceuticals, Inc. Application # =ANDA 75-685 Approval Date =3/30/00 Letter Posted =4/4/00 Label Posted = Review Posted = Ciprofloxacin Tablets USP, 100 mg, 250 mg, 500, and 750 mg, Rx Tentatively Approved 12/22/00 Danbury Pharmacal, Inc. Application # =ANDA 75-593 Approval Date =12/22/00 Letter Posted = Label Posted = Review Posted = Ciprofloxacin Tablets USP, 250 mg, 500 mg, 500 mg, and 750 mg, Tentatively Approved 3/24/99 Novopharm Application # =ANDA 74-876 Approval Date =3/24/99 Letter Posted =3/29/99 Label Posted = Review Posted =
    情報ソース●NDA APPROVALS FOR CALENDAR YEAR 2002 NDA Number =21473 DRUG NAME =Cipro XR Generic Name =Ciprofloxacin APPLICANT/SPONSOR=Bayer CHEMICAL TYPE =3 THERAPEUTIC CLASS=S APPROVAL DATE =13-Dec-02



    FDA CDER-Drug Information - Cipro (Ciprofloxacin Hydrochloride) for Inhalation Anthrax

    http://www.fda.gov/cder/drug/infopage/cipro/

    Cipro (ciprofloxacin hydrochloride) is an antibiotic used to treat bacterial infections in many different parts of the body. It does not work for viral infections (for example, the common cold). Cipro is approved for the inhaled form of anthrax after an individual has been exposed.  Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established, except for use in inhalational anthrax (post-exposure).  

    For more information about Cipro, please contact the Division of Drug Information at druginfo@cder.fda.gov or 1-888-INFOFDA (463-6332).




    ■メーカー情報

    Bayer AG

    ●売上 Best-selling Bayer healthcare products (Euro million) 2001 2000 1999 Ciprobay/ Cipro 1,964(+10%) 1,785(+18%) 1,519(+17%) ciprofloxacin ●Press Release U. S. registration for Bayer's CiproR XR antibiotic[2002.12.16] - 2003.1.2発売 Bayer Submits Additional New Drug Application For Once-Daily CiproR XR in US[2002.10.30] - 本日NDA追加申請。An Extended-Release Formulation for Complicated Urinary Tract Infections; 本剤のNDA申請は、2002.3に既に行われている。 Bayer's Cipro Patent Affirmed by U.S. Courts[2002.10.28]
    Pharma Bayer

    - http://www.pharma.bayer.com/ ●News RoomProducts www.cipro.com - http://www.ciprousa.com/http://www.ciprousa.com/ Infectious Disease Specialist Dr. Paul Iannini Comments on Important Considerations for Taking Antibiotics for the Treatment of Anthrax — November 2, 2001 Advertisement: An Important Message From Bayer: You Can Count on Us — October 31st, 2001 Flyer: Using Antibiotics Appropriately To Combat Bioterrorism — October 26th, 2001 Bayer, HHS Complete Cipro Agreement; Americans Assured of Ample Supplies of Cipro to Combat War on Bioterrorism — October 24, 2001 Bayer Supports FDA Review of Other Approved Antibiotics in Anti-Bioterrorism Fight — October 24, 2001 Bayer Supports FDA Revision Of Labeling Doxycycline For Treatment Of All Forms Of Anthrax — October 21, 2001 Advertisement: A Message from Bayer Corporation to the American People, Our Commitment to You — October 20, 2001 Bayer Confirms Cipro Talks with HHS and Reaffirms Offer of Donation Of 2 MM Cipro Tablets for Emergency Responders — October 20, 2001 Bayer Commits to Supply 200 Million Cipro Tablets Over the Next Three Months — October 16, 2001 FDA Approves Ciprofloxacin for Victims of Anthrax Inhalation — August 31, 2000
    バイエル薬品

    ニュース バイエル薬品、「シプロキサンR」に炭疽菌感染症への効能・効果を追加[2001.12.21]

    バイエル薬品、「シプロキサンR」に炭疽菌感染症への効能・効果を追加[2001.12.21]

    バイエル薬品(本社:大阪市、社長:アンソニー・ウィン)は、12月21日、ニューキノロン系合成抗菌剤「シプロキサンR」(一般名:シプロフロキサシン)の「炭疽」への「効能・効果」、「用法・用量」追加承認を他のニューキノロン剤に先駆けて取得しました。当社では、厚生労働省の要請を受けて、本年10月末にその申請を行っていましたが、今回承認されたものです。

    シプロフロキサシンの炭疽菌感染症に対する「効能・効果」の追加は、米国では既に2000年8月に承認されています。最近、ドイツと英国においても承認されましたので、日本は世界で4番目の承認国になりました。

    シプロフロキサシンは、日本では「シプロキサンR」として1988年に錠剤が発売され、1998年に細粒、さらに2000年11月には注射剤が発売され、各種感染症の治療に広く使用されています。

    炭疽に関する意見書(社団法人 日本感染症学会)について

    2001.10.13 厚生労働省大臣官房厚生科学課
    近米国において生物テロとして問題となっている炭疽(病)の治療および薬剤予防投与の考え方について、日本の感染症学会から厚生労働省に対し、別紙(PDF98KB)のような意見が提出されましたので公開します。
     なお、この意見は、あくまで現時点における感染症学会としての意見であり、そのまま厚生労働省の見解というものではありませんので、ご注意下さい。

    日本感染症学会 炭疽症治療薬で厚労省に意見書 [薬事日報 01/10/22]

     米国での炭疽菌事件を受け日本感染症学会は十六日付で、厚生労働省に対し、米国の治療指針を参考にした治療案を提示し、日本と抗菌薬の適応がそぐわなくても「炭疽が明らかか、極めて疑わしい場合は必要な治療に配慮をお願いしたい」との意見書を提出した。

     米国の事件でも炭疽菌が自然由来なのか遺伝子工学によるものなのか分かっていないが、いずれしてもニューキノロン系が効果があるとされているとして、「ニューキノロン系抗菌薬の開発に優れたわが国においては、炭疽菌に対する抗菌薬の不足を心配する必要はないものと考えられる」との見解も示した。

     意見書では、菌が自然由来の場合は、ペニシリン系、テトラサイクリン系、ニューキノロン系などが「好んで使われる」とした上で、クロラムフェニコール、エリスロマイシン、ストレプトマイシンも効果があるといわれていることを紹介。

     遺伝子工学的に薬剤耐性遺伝子を組み込んだ炭疽菌にも触れ、「モデル動物を使った実験での効果がはっきりしているシプロフロキサシン」が米国の論文では第一選択薬とされているとしながらも、「レボフロキサシン、オフロキサシンなど他のニューキノロン系抗菌薬も効果があるとされている」と指摘している。

    
    
    
    
    ●参考

    Doxycycline for Inhalational Anthrax (Post-Exposure) [2001.11.1]








    [1413]●製品 炭疽治療薬ラキシバクマブRaxibacumab(Raxibacumab[GSK])


     日本語版註)炭疽治療薬ラキシバクマブRaxibacumab(Raxibacumab[GSK])
     【別名】Abthrax 【開発元】Human Genome Sciences, Inc →3-Aug-2012GSKが買収  [DBR_ID]
     【化学名】Raxibacumab is a human IgG1λ monoclonal antibody that binds the PA component of B.anthracis toxin. Raxibacumab has a molecular weight of approximately 146 kilodaltons. Raxibacumab is produced by recombinant DNA technology in a murine cell expression system.
     【承認】FDA申請=May-2009、FDA承認非勧告=16-Nov-2009、FDA再申請=15-Jun-2012、FDA承認勧告=2-Nov-2012、FDA承認=Dec. 14, 2012[Human Genome Sciences, Inc]、米国発売 ;
     【製剤】Each vial contains 50 mg/mL raxibacumab in citric acid (0.13 mg/mL), glycine (18 mg/mL), polysorbate 80 [0.2 mg/mL (w/v)], sodium citrate (2.8 mg/mL), and sucrose (10 mg/mL), with a pH of 6.5. 【適応】(肺炭疽病の治療だけでなく、代替薬がない場合か効果が不十分な場合の肺炭疽病の予防の適応) indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. 【用法用量】1)diphenhydramineを前投与 2)2時間15分かけて、成人はraxibacumabを40 mg/kg、50kg以上の小児は40 mg/kg、15-50kgの小児は60 mg/kg、15kg未満の小児は80 mg/kgを静脈内投与。
     【作用】Raxibacumab is a monoclonal antibody that binds free PA with an affinity equilibrium dissociation constant (Kd) of 2.78 ± 0.9 nM. Raxibacumab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin. It does not have direct antibacterial activity. 【特徴】Raxibacumab is a monoclonal antibody that binds the PA of B. anthracis 
     【添付文書】Raxibacumab-PI
     【提携】 【EU】 
     【日本】未開発 
    
    
    



    【日本語版コメント1413〜炭疽治療薬ラキシバクマブRaxibacumab(GSK)/2013.04.01】
    炭疽菌は、その胞子は破壊しにくく、空中に容易に散布が可能なことからバイオテロリズムの道具として使用される恐れがある。2001年9月米国で、放送局や一部連邦議会議員に対して、郵便で炭疽菌が送付され、5名の死亡者、10名以上の負傷者を生んだバイオテロ事件が発生し、米国社会を大きく揺るがし、炭疽菌について世界中の注目を集めた。

    現在日本で「炭疽」の適応を取得しているのは、アンピシリン、ベンジルペニシリンカリウム、テトラサイクリン塩酸塩、デメチルクロルテトラサイクリン塩酸塩、ミノサイクリン塩酸塩、ドキシサイクリン塩酸塩、シプロフロキサシン、ノルフロキサシン、レボフロキサシン、トスフロキサシントシル酸塩。 海外では、 炭疽菌ワクチンBiothrax[Emergent BioSolutions Inc]も販売されてる。

     →詳細は参考資料●MLリソース:生物兵器に纏めた。
    



    ●承認データ:FDA

    FDA Newsroom - FDA Press Releases FDA approves raxibacumab to treat inhalational anthrax[Dec. 14, 2012] Index to Drug-Specific Information ●2004.5.1 以降 Drugs@FDA

    ★Drug Name(s) =RAXIBACUMAB (RAXIBACUMAB) FDA Application No. =(BLA) 125349 Active Ingredient(s)=RAXIBACUMAB Company =HUMAN GENOME SCIENCES INC Dosage Form/Route =INJECTABLE; IV (INFUSION) Strength =1700MG/34ML (50MG/ML) - Approval Date=12/14/2012[000][Approval]:Label[添付文書]|Letter[承認書]|Review|Summary Review   申請Jun 15,2012  適応 Original Approval or Tentative Approval Date December 14, 2012
    ●FDA Advisory Committees

    参考●ML資料:FDA諮問委員会〜議題 FDA Advisory Committees CDER■Anti-Infective Drugs - http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/default.htm Anti-Infective Drugs 2013 - 2012 - 2011 - 2010 - 2009 - 2008 - 2007 - 2006 - 2004 - 2003 - 2002 - 2001
    ML開催日議題備考
    14132012.11.02 (BLA) 125346, raxibacumab injection, a humanized monoclonal antibody against protective antigen of Bacillis anthracis, by Human Genome Sciences, Inc. for the proposed indication of treatment of inhalational anthrax 
    ※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [有効性] Yes=16,No=1,保留=1  [安全性] Yes=18,No=0,保留=0
    raxibacumab
    14132009.10.27(BLA) 125349, for raxibacumab injection, manufactured by Human Genome Sciences, Inc., proposed for the treatment of inhalational anthrax disease(炭疽菌). 
    ※資料Briefing Information | Slides | 議事録Transcript | 【審議結果/Minutes】 [動物モデルでのraxibacumabの効果が人体での反応を予測可能か] Yes=16,No=7,保留=1  [raxibacumabは炭疽菌での抗菌剤の効果を低減しないか?] Yes=10,No=11,保留=3
    raxibacumab








    ●他の炭疽菌治療薬


    【米国薬事情報】炭疽に対する抗生物質ドキシサイクリン使用

    薬事日報 2001.10.31
    米保健福祉省(HHS)トミー・G・トンプソン長官は議会上院の政府活動委員会及び国際安全保障・拡散・連邦サービス小委員会で十七日に証言し、FDAは炭疽の治療に使う数種の抗生物質について新しい添付文書の承認を考えていると語った。

     ドキシサイクリンの投与方法に関する医療従事者向けの説明は次の通り発表された。FDAは炭疽治療用の同剤及び他の抗生物質の使用情報を開発中で、その情報は早急に提供される。

     ドキシサイクリンはすべての剤型が炭疽の治療用として使用を承認されている。FDAは皮膚炭疽及び肺炭疽(菌被曝を含む)の治療用量に関して追加情報を準備中である。重篤症状に対するドキシサイクリンの現行推奨用量は成人については十二時間ごとに一〇〇mg、体重一〇〇ポンド以下の小児については十二時間ごとに体重一ポンド当たり一mg(二・二mg/kg)である。これらの用量は被曝経路に関係なく、炭疽菌被曝患者用としても適当である。

     FDAその他の保健当局は、医師から特段の指示がなく、炭疽菌被曝の明らかな証拠もない個人が、炭疽の予防にこの抗生物質を服用するのは思いとどまるよう強く警告している。

    ●炭疽菌検査薬の販売を再開 日本ビオメリュー

    薬事日報 01/11/28 
     日本ビオメリューは一時的に販売を中止していた炭疽菌鑑別用検査試薬「アピ50C
    H」「アピ50CHB」の一般検査施設への販売を再開した。同試薬が炭疽菌検査手順の
    確定試験用試薬になっていることに加え、公的機関の対応が明確になったため。 
     今後も同社のホームページ(http://www.bvj.co.jp)に情報を提示し、顧客センターによる情報提供に努める。
    ●BioMerieux -http://www.biomerieux.com/
    ●BioMerieux本社 -http://www.biomerieux.fr/
    ●BioMerieux米国 -http://www.biomerieux-vitek.com/
    ●bioMerieux Japan -http://www.biomerieux.co.jp/
    H13.11.20 炭疸菌鑑別用検査試薬「アピ50CH」「アピ50CHB」の一般検査施設への販売再開について
    H13.10.26 炭疸菌に関連する弊社検査試薬「アピ50CH」に対するお問い合わせについて
    H13.10.22 弊社炭疸菌鑑別用試薬アピ50CH,アピ50CHBの一般検査施設での販売中止について
    H13.10.19 生物テロに使用される可能性が高いと考えられている感染症の鑑別診断薬について
    
    

    炭疽菌検出試薬 ロシュ・ダイアグノスティックス[薬事日報 01.11.12]

    ロシュ・ダイアグノスティックスは六日、米国メイヨー・クリニックと協力し、ヒト検体および環境中での炭疽菌検出用DNA検査キットの開発に成功したと発表した。同キットでは一時間以内で炭疽菌を検出できる。

     同社では初期段階において、同キットを各検査機関に無料提供することを計画している。来週早々には米国の二四検査機関で同キットの採用が検討される。

    Roche Diagnostics -http://www.roche-diagnostics.com/
    Press release
    New rapid Anthrax test developed through collaboration between Mayo Clinic and Roche Diagnostics[2001.11.5]
     - 2003.2.17現在製品としては販売されていない。
    
    

    2001.11.9 【生物テロ】NEJM誌、炭疽に関する論文を早期公開 [Medwave]
    New England Journal of Medicine(NEJM)誌は11月6日、炭疽の最新知識や症例に関する二つの論文をホームページ上で公表した。疾患の治療や予防に大きなインパクトを持つ論文を、雑誌掲載に先立って公表する「Early Release」(早期公表)制度による。 今回公表された2論文は、NEJM誌11月29日号に掲載される。

     論文は、炭疽に関する最新情報を網羅的に紹介したものと、今年9月にニューヨークで皮膚炭疽に罹患した小児の症例報告の2報。前者は、炭疽菌の生物学的・病理的な特徴や炭疽の疫学、肺炭疽や皮膚炭疽など各種炭疽の臨床症状や転機、抗菌薬を用いる治療や予防、院内感染の防止策などについて、現在までに得られた知見を解説している。後者は、親の勤務するテレビ局で皮膚炭疽に罹患したと考えられる2歳小児の症例を、写真付きで報告している

    NEW England J Med,special notice:Information about Anthrax and Other Biologic Threats
    http://nejm.org/specialnotice/
    Updated November 28, 2001
    



    ■炭疸菌 Anthrax

    ●WHO 炭疽菌情報

    WHO-CSR[Communicable Disease Surveillance and Response] -http://www.who.int/csr/en/ WHO-CSR-Disease -http://www.who.int/entity/csr/disease/en WHO-CSR-Disease: Anthrax -http://www.who.int/entity/csr/disease/Anthrax/en ★WHO Fact Sheet: Anthrax[#264 ,] -http://www.who.int/inf-fs/en/fact264.html ★WHO- Disease Outbreak News: Anthrax -http://www.who.int/disease-outbreak-news/disease/A22.htm ★WHO Health Topics: Anthrax -http://www.who.int/health_topics/anthrax/en ★WHO: Guidance on AnthraxGuidelines for the Surveillance and Control of Anthrax in Humans and Animals - WHO/EMC/ZDI/98.6. - www.who.int/emc-documents/zoonoses/ docs/whoemczdi986.html ★Guidelines for the Surveillance and Control of Anthrax in Humans and Animals - WHO/EMC/ZDI/98.6. - www.who.int/emc-documents/zoonoses/whoemczdi986c.html ★WHO - Mediacentre - Anthrax Photo page - Anthrax. All the pictures are free to download and to use, with the mention - www.who.int/multimedia/anthrax/photo.html ★Anthrax-publications - www.who.int/emc/diseases/zoo/vphpublications/Abstracts/anthrax.html - ★anthrax-publications - www.who.int/emc/diseases/zoo/vphpublications/anthrax.html - ★6: Guidelines for the Surveillance and Control of Anthrax in Humans and Animals[WHO]


    ●CDC: 炭疸菌 Anthrax

    CDC: Information on Anthrax


    Last update: 2/25/98
    Anthrax (Bacillus anthracis)
    Frequently Asked Questions

    ★What is anthrax?
    Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in warm-blooded animals, but can also infect humans.

    ★How common is anthrax and who can get it?
    Anthrax is most common in agricultural regions where it occurs in animals. These include South and Central America, Southern and Eastern Europe, Asia, Africa, the Caribbean, and the Middle East. When anthrax affects humans, it is usually due to an occupational exposure to infected animals or their products. Workers who are exposed to dead animals and animal products (industrial anthrax) from other countries where anthrax is more common may become infected with B. anthracis. Anthrax in animals rarely occurs in the United States. Most reports of animal infection are received from Texas, Louisiana, Mississippi, Oklahoma and South Dakota.

    ★How is anthrax transmitted?
    Anthrax infection can occur in three forms: cutaneous (skin), inhalation, and gastrointestinal. B. anthracis spores can live in the soil for many years and humans can become infected with anthrax by handling animal products from infected animals or by inhaling anthrax spores from contaminated animal products. Anthrax can also be spread by eating undercooked meat from infected animals. It is rare to find infected animals in the United States.

    ★What are the symptoms of anthrax?
    Symptoms of disease vary depending on how the disease was contracted, but symptoms usually occur within seven days.

    Cutaneous: Most anthrax infections occur when the bacterium enters a cut or abrasion on the skin, such as when handling contaminated wool, hides, leather or hair products (especially goat hair) of infected animals. Skin infection begins as a raised itchy bump that resembles an insect bite but within 1-2 days develops into a vesicle and then a painless ulcer, usually 1-3 cm in diameter, with a characteristic black necrotic (dying) area in the center. Lymph glands in the adjacent area may swell. About 20% of untreated cases of cutaneous anthrax will result in death. Deaths are rare with appropriate antimicrobial therapy.

    Inhalation: Initial symptoms may resemble a common cold. After several days, the symptoms may progress to severe breathing problems and shock. Inhalation anthrax usually results in death in 1-2 days after onset of the acute symptoms.

    Intestinal: The intestinal disease form of anthrax may follow the consumption of contaminated meat and is characterized by an acute inflammation of the intestinal tract. Initial signs of nausea, loss of appetite, vomiting, fever are followed by abdominal pain, vomiting of blood, and severe diarrhea. Intestinal anthrax results in death in 25% to 60% of cases.

    ★Where is anthrax usually found?
    Although anthrax can be found globally, it is more often a risk in countries with less standardized and effective public health programs. Areas currently listed as high risk are South and Central America, Southern and Eastern Europe, Asia, Africa, the Caribbean, and the Middle East.

    ★Can anthrax be spread from person-to-person?
    Direct person-to-person spread of anthrax most likely does not occur.

    ★How is anthrax diagnosed?
    Anthrax is diagnosed by isolating B. anthracis from the blood, skin lesions, or respiratory secretions or by measuring specific antibodies in the blood of suspected cases.

    ★What is the treatment for anthrax?
    Doctors can prescribe effective antibiotics. Usually penicillin is preferred, but erythromycin, tetracycline, or chloramphenicol can also be used. To be effective, treatment should be initiated early. If left untreated, the disease can be fatal.

    ★Is there an anthrax vaccine for humans?
    The anthrax vaccine for humans licensed for use in the United States is a cell-free filtrate vaccine, which means it uses dead bacteria as opposed to live bacteria. Anthrax vaccine is indicated for individuals who come in contact in the workplace with imported animal hides, furs, bonemeat, wool, animal hair (especially goat hair), and bristles; and for individuals engaged in diagnostic or investigational activities which may bring them into contact with anthrax spores. The vaccine is reported to be 93% effective in protecting against cutaneous anthrax. The anthrax vaccine was developed and is manufactured and distributed by the Michigan Biologic Products Institute, Lansing, Michigan. Anthrax vaccines intended for use in animals should not be used in humans.

    ★Who should be vaccinated against anthrax?
    Because anthrax is considered to be a potential agent for use in biological warfare, the Department of Defense recently announced that it will begin systematic vaccination of all U.S. military personnel. Among civilians, the Advisory Committee for Immunizations Practices (ACIP), recommends anthrax vaccine be given to individuals who come in contact in the workplace with imported animal hides, furs, bonemeat, wool, animal hair (especially goat hair), and bristles; and for individuals engaged in diagnostic or investigational activities which may bring them into contact with anthrax spores. The vaccine should only be administered to healthy men and women from 18 to 65 years of age since investigations to date have been conducted exclusively in that population. Because it is not known whether the anthrax vaccine can cause fetal harm, pregnant women should not be vaccinated.

    ★What is the protocol for anthrax vaccination?
    The immunization consists of three subcutaneous injections given two weeks apart followed by three additional subcutaneous injections given at 6, 12, and 18 months. Annual booster injections of the vaccine are required to maintain immunity.

    ★Are there adverse reactions to the anthrax vaccine?
    Mild local reactions occur in 30% of recipients and consist of slight tenderness and redness at the injection site. A moderate local reaction can occur if the vaccine is given to anyone with a past history of anthrax infection. Severe local reactions are very infrequent and consist of extensive swelling of the forearm in addition to the local reaction. Systemic reactions occur in fewer than 0.2% of recipients and are characterized by flu-like symptoms.

    ★Where can I get more information about a recent Department of Defense decision to require men and women in the Armed Services to be vaccinated against anthrax?
    The Department of Defense recommends servicemen and women contact their chain of command on questions about the vaccine and its distribution.

    URL: http://www.cdc.gov/ncidod/dbmd/anthrax.htm



    MEDLINEplus: Anthrax

    Contents of this page: News From the NIH General/Overviews Alternative Therapy Clinical Trials Diagnosis/Symptoms Pictures/Diagrams Prevention/Screening Research Specific Conditions/Aspects Treatment Law and Policy Organizations Children Teenagers Women Search MEDLINE for recent research articles on ・ Anthrax You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismInfectionsPoisoning, Toxicology, Environmental HealthLatest News CDC Chief: Bioterror Threat Remains Real (01/30/2003, Associated Press) ●From the National Institutes of Health Anthrax (National Institute of Allergy and Infectious Diseases) ●General/Overviews Anthrax (Patient Education Institute) - requires Flash plug-in Anthrax: Frequently Asked Questions (National Center for Infectious Diseases) Also available in: Spanish FAQs about Anthrax (Centers for Disease Control and Prevention) What is Anthrax? (Nemours Foundation) ●Alternative Therapy Bioterrorism and CAM (Complementary and Alternative Medicine): What the Public Needs To Know (National Center for Complementary and Alternative Medicine) ●Clinical Trials ClinicalTrials.gov: Anthrax (National Institutes of Health) ●Diagnosis/Symptoms What's the Difference Between Flu and Anthrax Symptoms? (Food and Drug Administration) ●Pictures/Diagrams Cutaneous Anthrax -- Vesicle Development (Centers for Disease Control and Prevention) Inhalational Anthrax (Centers for Disease Control and Prevention) ●Prevention/Screening Anthrax Vaccination (National Network for Immunization Information) Anthrax Vaccine (Centers for Disease Control and Prevention) How We're Making the Public and Employees Safe (United States Postal Service) Irradiated Mail (Environmental Protection Agency, Office of Air and Radiation) Updated Information About How to Recognize and Handle a Suspicious Package or Envelope (Centers for Disease Control and Prevention) ●Research Answers on Anthrax (National Institute of General Medical Sciences) Anthrax Findings Presented by NIH Researcher (National Institutes of Health, Clinical Center) Molecular Mechanism Underlying Anthrax Infection Described by NIEHS-funded Researchers (National Institute of Environmental Health Sciences) Researchers Discover Secrets of Anthrax's Killer Toxin (National Institute of Allergy and Infectious Diseases) Researchers Unravel Anthrax Genomes (National Institute of Allergy and Infectious Diseases) ●Specific Conditions/Aspects Anthrax in the Workplace (Occupational Safety and Health Administration) Offers to Treat Biological Threats: What You Need to Know (Federal Trade Commission) Also available in: SpanishTreatment Cipro (Ciprofloxacin Hydrochloride)for Inhalation Anthrax (Food and Drug Administration) Patient Information on Amoxicillin (Centers for Disease Control and Prevention) Patient Information on Ciprofloxacin (Centers for Disease Control and Prevention) Questions and Answers for Consumers on Doxycycline (Center for Drug Evaluation and Research) Questions and Answers for Consumers on Penicillin G Procaine (Center for Drug Evaluation and Research) ●Law and Policy FTC Announces First Two Enforcement Actions Against Purveyors of Bioterrorism Defense Products (Federal Trade Commission) ●Organizations Anthrax Vaccine Immunization Program (Dept. of Defense) Johns Hopkins University, Center for Civilian Biodefense Strategies National Institute of Allergy and Infectious Diseases Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention) Also available in: SpanishChildren Anthrax/Bioterrorism Q and A (American Academy of Pediatrics) Children and Anthrax: A Fact Sheet for Parents (Centers for Disease Control and Prevention) What is Anthrax? (Nemours Foundation) ●Teenagers What Is Anthrax? (Nemours Foundation) ●Women Guidelines for Pregnant Women Who Have Been Exposed to Anthrax But Do Not Have Symptoms (National Center on Birth Defects and Developmental Disabilities) Interactive Tutorial View slideshow on: Anthrax Page last updated: 03 February 2003








    ●他の生物兵器の特定感染菌

    WHO-CSR[Communicable Disease Surveillance and Response]
     -http://www.who.int/csr/en/
    WHO-CSR-Disease
     -http://www.who.int/entity/csr/disease/en
    WHO-CSR-Disease: Hepatitis -http://www.who.int/entity/csr/disease/hepatitis/en
    WHO-CSR-Disease: Influenza -http://www.who.int/entity/csr/disease/influenza/en
    
    
    ●WHO Health Topics -http://www.who.int/health_topics/en/
    ★WHO Health Topics: Vaccines -http://www.who.int/health_topics/vaccines/en
    
    ★WHO Health Topics: Meningitis -http://www.who.int/health_topics/meningitis/en
    ★WHO Health Topics: Chemical Weapons -http://www.who.int/health_topics/chemical_weapons/en
    




    ■ペスト plague

    ●WHO/OMS: Search - ペスト plague

    WHO-CSR[Communicable Disease Surveillance and Response]
     -http://www.who.int/csr/en/
    WHO-CSR-Disease
     -http://www.who.int/entity/csr/disease/en
    WHO-CSR-Disease: Plague -http://www.who.int/entity/csr/disease/plague/en
    
    ★WHO Fact Sheet: PLAGUE[#267] January 2002
     -http://www.who.int/inf-fs/en/fact267.html
    ★WHO- Disease Outbreak News :Plague
     -http://www.who.int/disease-outbreak-news/disease/A20.htm
    
    ★WHO Health Topics: Plague -http://www.who.int/health_topics/plague/en/
    




    ●CDC: ペスト plague

    Plague Links
    --------------------------------------------------
    CDC: Information on Plague

    世界全体では1995年に10か国でペスト患者2861人が発生。 米国でも1971-1995間に年1-40人が罹患。 Prairie dogs can harbor fleas infected with Yersina pestis, the bacterium that causes plague.

    Plague
    Plague fact sheet.
    Detailed information on plague.
    Woldwide* distribution of plague.
    Map* of reported human plague cases by U.S. county, 1970-1997
    Images of fleas that transmit plague.
    Prevention of plague: Recommendations* of the Advisory Committee on Immunization Practices, MMWR, December 13, 1996.
    *(requires the Adobe Acrobat Reader(TM) to view.
    Updated: January 1999
    --------------------------------------------------
    Plague fact sheet
    
    CLINICAL FEATURES
    Bubonic plague: enlarged, tender lymph nodes, fever, chills and prostration
    Septicemic plague: fever, chills, prostration, abdominal pain, shock and bleeding into skin and other organs
    Pneumonic plague: fever, chills, cough and difficulty breathing; rapid shock and death if not treated early
    
    ETIOLOGIC AGENT
    Yersinia pestis - bacillus
    
    INCIDENCE
    In the U.S., 1 to 40 cases reported annually (avg = 13 cases) by western states, 1971-1995
    Worldwide, 2861 cases reported by 10 countries to WHO in 1995
    
    SEQUELAE
    Rare, consequences of disseminated intravascular coagulation, lung damage
    Mortality 50-90% if untreated; 15% when diagnosed and treated
    
    COSTS
    Not known
    
    TRANSMISSION
    Flea-borne, from infected rodents to humans
    Direct contact with infected tissues or fluids from handling sick or dead animals
    Respiratory droplets from cats and humans with pneumonic plague
    
    RESERVOIRS
    Primarily wild rodents in U.S. (especially rock squirrels, ground squirrels, prairie dogs, other burrowing rodents)
    Commensal rats may be important elsewhere
    
    RISK GROUPS
    In the U.S, persons exposed to rodent fleas, wild rodents, or other susceptible animals in enzootic areas of western states
    Most cases occur in southwestern states of NM, AZ, CO, and in CA
    Highest rates in Native Americans, especially Navajos; other risk groups: hunters; veterinarians and pet owners handling infected cats; campers or hikers entering areas with outbreaks of animal plague
    
    SURVEILLANCE
    National Notifiable Disease Surveillance System (NNDSS) for animal plague surveillance, for reports of human cases, and laboratory testing of fleas, animal tissues and serum specimens, and serosurveys of carnivores
    CDC, Fort Collins, is a WHO Collaborating Center for Reference and Research on Plague Control, and reports all human plague cases in the U.S. to WHO
    
    OPPORTUNITIES
    Increased self-sufficiency of state and county public health labs
    Expanded active surveillance through carnivore serosurveys and application of geographic information systems (GIS) to surveillance programs
    Increased education of public and health professionals
    Collaborative applied research on plague prevention and control with other federal, state, and local health agencies, including application of GIS to surveillance
    
    RESEARCH
    Ecology-based prevention and control strategies
    Improved diagnostic reagents and methods
    Development of potential vaccine candidates
    Risk factor identification using landscape ecology and epidemiology
    
    
    
    MEDLINEplus: Plague

    Contents of this page: News General/Overviews Diagnosis/Symptoms Pictures/Diagrams Prevention/Screening Research Specific Conditions/Aspects Organizations Statistics Search MEDLINE for recent research articles on ・ Plague You may also be interested in these MEDLINEplus related pages: ・ Biodefense and BioterrorismInfectionsLatest News Co. Wins US Contract for Plague, Anthrax Vaccine (01/22/2003, Reuters Health) New Test Detects Plague in Minutes (01/17/2003, United Press International) Missing Vials of Plague Samples Found in Texas After Triggering Bioterrorism Fears (01/16/2003, Associated Press) ●General/Overviews Information on Plague (Centers for Disease Control and Prevention) Plague (World Health Organization) Questions and Answers About Plague (National Center for Infectious Diseases) ●Diagnosis/Symptoms Plague: Diagnosis (Centers for Disease Control and Prevention) ●Pictures/Diagrams Plague Images (Centers for Disease Control and Prevention) ●Prevention/Screening Plague: Prevention (Centers for Disease Control and Prevention) ●Research Plague (National Institute of Allergy and Infectious Diseases) ●Specific Conditions/Aspects Facts about Pneumonic Plague (Centers for Disease Control and Prevention) Frequently Asked Questions (FAQ) About Plague (Centers for Disease Control and Prevention) Plague (Johns Hopkins University, Center for Civilian Biodefense Strategies) Plague and Animals (National Center for Infectious Diseases) Plague: Epidemiology (Centers for Disease Control and Prevention) ●Organizations National Center for Infectious Diseases National Institute of Allergy and Infectious Diseases Public Health Emergency Preparedness and Response Program (Centers for Disease Control and Prevention) Also available in: Spanish WHO/OMS: World Health Organization (World Health Organization) ●Statistics Plague (World Health Organization) Page last updated: 03 February 2003




    ■野兎病 tularemia

    ●WHO/OMS: Search - 野兎病 tularemia

    WHO-CSR[Communicable Disease Surveillance and Response]
     -http://www.who.int/csr/en/
    WHO-CSR-Disease
     -http://www.who.int/entity/csr/disease/en
    
    ★WHO- Disease Outbreak News: Tularemia
     -http://www.who.int/disease-outbreak-news/disease/A21.htm
      コソボにて発生
    



    ■ブルセラ Brucellosis

    ●WHO: ブルセラ情報

    WHO-CSR[Communicable Disease Surveillance and Response] -http://www.who.int/csr/en/ WHO-CSR-Disease -http://www.who.int/entity/csr/disease/en ★WHO Fact Sheet: Brucellosis[#173 ,July 1997] -http://www.who.int/inf-fs/en/fact173.html ★WHO Health Topics: Brucellosis -http://www.who.int/health_topics/brucellosis/en



    ●WHO/OMS: ブルセラ Brucellosis :Fact Sheet N173

    出典●WHO: Information Office - Facts Sheets index alphabetical
    地中海・中近東諸国でブルセラ菌感染は人口10万人比年1-78人の割合で発生。 July 1997
    Animal and human health are inextricably linked. People depend on animals for nutrition, socio-economic development and companionship. Yet animals can transmit many different diseases to humans. Diseases transmitted from animals to humans are termed zoonoses and some of them are potentially devastating.
    Brucellosis is a zoonosis of both public health and economic significance in most developing countries. In many developed countries, the animal disease has been brought under control, which has led to a subsequent decrease in the number of human cases. The occurrence of the disease in humans is largely dependent on the animal reservoir. Where brucellosis exists in sheep and goats, it causes the greatest incidence of infection in humans.
    Causes Six species of Brucella are currently presently known, of which Brucella melitensis, Brucella suis and Brucella abortus have public health implications. Brucella melitensis occurs more frequently than the other types in the general population and it is the most pathogenic and invasive species of Brucella, followed, in order, by Brucella suis and Brucella abortus.
    Transmission Brucellosis is transmitted through contaminated and untreated milk and milk products and by direct contact with infected animals (cattle, sheep, goats, pigs, camels, buffaloes, wild ruminants and, very recently, seals), animal carcasses, and abortion materials. Worldwide, millions of individual are at risk, especially in developing countries where the infection in animals has not been brought under control, heat treatment procedures of milk (e.g. pasteurization) are not routinely applied, and food habits such as consumption of raw milk and poor hygienic conditions favour human infection. In such conditions transmission of the infection to humans may frequently occur. Although the disease in animals has been brought under control in several industrialised countries, it occurs sporadically in individuals who acquire the infection abroad or by ingestion of unsafe animal products and in occupationally exposed groups (e.g. farmers, veterinarians, laboratory and slaughterhouse workers).

    Main clinical symptoms The incubation period of brucellosis is usually one to three weeks, but sometimes may be several months. The illness may be mild and self-limiting or severe. It may have either a sudden or insidious onset and is accompanied by continued, intermittent, or irregular fever. The symptomatology of brucellosis is like that of many other febrile diseases, but with a marked effect on the musculoskeletal system evidenced by generalized aches and pains and associated with fatigue, prostration and mental depression. Urogenital symptoms may dominate the clinical presentation in some patients. The duration of the disease can vary from a few weeks to several months and laboratory tests are needed to confirm the clinical diagnosis.

    Prevention Brucellosis can be prevented in humans by controlling, or better, eliminating the disease in the animal population and avoiding consumption of raw milk and raw milk products. Brucellosis control programmes based on various strategies, including vaccination and/or test-and-slaughter of infected animals, have been successful in controlling the disease in animals in several countries, resulting in a drastic reduction in its incidence in the human population. Proper heat treatment of milk or milk products is important for effective prevention of brucellosis in humans. However, local customs, traditional habits and beliefs may impede the wide application of such measures. Health education should be intimately linked with all phases of prevention and control activities.
    Treatment Antibiotics are effective against Brucella. However, Brucella is localized intracellularly like certain other micro-organisms (e.g., Mycobacterium tuberculosis), and requires the association of more than one antimicrobial for several weeks.
    Possible drug resistance Antimicrobial resistant strains of Brucella are reported; however, their clinical implications are not yet fully understood. Some of the commonly-used antimicrobials for brucellosis treatment (i.e. Rifampicin and Streptomycin) are also first line drugs for the treatment of tuberculosis. The present worldwide occurrence of multi-drug resistant strains of pathogenic Mycobacterium tuberculosis poses the urgent question of an alternative treatment for brucellosis, using antimicrobial agents not employed for tuberculosis.

    Worldwide burden of the disease Although human brucellosis is a notifiable disease in many countries, official figures do not fully reflect the number of people infected each year and the true incidence has been estimated to be between 10 and 25 times higher than what reported figures indicate. Cases very often remain unrecognized because of inaccurate diagnosis, and are thus treated as other diseases or as "fever of unknown origin". Animal brucellosis also poses a barrier to trade of animals and animal products and could seriously impair socio-economic development, especially of livestock owners, a most vulnerable sector in many rural populations. As an indication of the importance of this disease, plans to eliminate ovine, caprine and bovine brucellosis from the European Union were expected to receive over half of the total European Commission funding for animal diseases control measures in 1997.
    Brucellosis in humans and animals is increasing in certain parts of the world, especially in developing areas of the Mediterranean Region, Middle East, western Asia and parts of Africa and Latin America. Brucella melitensis especially, being very pathogenic for human beings, constitutes a public health priority. Its recent emergence as a bovine pathogen in intensive dairy farms causes particular concern. A similar problem has also been reported where Brucella suis has become established in cattle.
    In Mediterranean and Middle East countries the annual incidence of brucellosis in people varies from less than 1 up to 78 cases per 100 000; however, over 550 cases have been reported from confined endemic areas where no animal control measures are applied. Up to 77 cases per 100 000 people have been reported from certain communities of south European countries in which animal control measures are mandatory. Reported cases largely underestimate the size of the problem. From a recent survey in a randomly selected human population of a country of the Arabic Peninsula, serological evidence of exposure to Brucella has been found to be close to 20%, with more than 2% of these having active disease. Similar figures may be expected from most countries in which the disease is endemic in the animal population. Higher seroprevalence of brucellosis should also be expected in occupationally exposed groups.
    WHO's efforts to combat brucellosis WHO has been involved in brucellosis work since its establishment and a number of programmes are underway to strengthen brucellosis surveillance activities at global level and to reduce the incidence of human brucellosis.
    In collaboration with the Food and Agriculture Organization of the United Nations, Rome, Italy (FAO) and the Office international des Epizooties, Paris, France (OIE), WHO is promoting implementation of a regional control programme in Middle East countries. The Mediterranean Zoonoses Control Programme (MZCP) of WHO is coordinating a study on the evaluation of new treatment regimes for human brucellosis. The results of the pilot feasibility study were recently evaluated and the main study should begin by October 1997.
    WHO and the United Nations Development Programme (UNDP) are jointly assisting the Palestinian Authority to develop and implement a programme for the control of human and animal brucellosis in the West Bank and Gaza Strip. In the Americas Region, the Pan-American Health Organization and the Regional Office of WHO have launched an initiative for bovine brucellosis elimination from Latin American countries. WHO has also developed a number of educational material for the attention of travellers and consumers on dietary precautions, promoting, among others, heat treatment of milk and derived products. WHO is currently developing guidelines for integrated surveillance of brucellosis and promoting research on new brucellosis vaccines for both humans and animals.
    ____________________
    For further information, journalists can contact 1) Health Communications and Public Relations, WHO, Geneva, tel. (4122) 791 2584, fax (4122) 791 4858; 2) the Division of Emerging and other Communicable Diseases Surveillance and Control (EMC), WHO, Geneva, fax (4l22) 79l 4893; phone (4122) 79l 2531; e-mail: cosivio@who.ch.





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