Home >News > ProMED翻訳情報(252回) ~インドで発生した狂犬病ワクチンによる人の死亡事例~

ProMED翻訳情報(252回) ~インドで発生した狂犬病ワクチンによる人の死亡事例~


狂犬病ワクチン、重大な有害事件 – インド:(パンジャブ)死亡、情報提供依頼
Date: Fri 7 Mar 2014  Source: Hindustan Times [edited]

Two days after the death of a 10-year-old AK at the civil hospital in Samana [Punjab state], the state drug controller authority has shot a letter to the drug controller general of India (DCGI), urging it to immediately stop the use of anti-rabies vaccine in the country.
A copy of the letter has been sent to all civil surgeons into the state, with an instruction to discontinue the use of the vaccine in the wake of this recent tragedy.
Samana [Punjab 州]の市民病院で10才のAKが亡くなった2日後、国内の抗狂犬病ワクチンの使用を直ちに停止させるために、州医薬品規制局はインド薬品規制総局(DCGI)に書簡を送った。

The vaccine, AbhyaRab, has been manufactured by the Human Biological Institute, Tamil Nadu [state], which has supplied it to the entire state [Punjab]. The vaccine is available at all government hospitals in the state. However, with its quality coming under cloud now, the use of the vaccine has been suspended with immediate effect.
そのワクチンAbhyaRabは、州[パンジャブ]全体にそれを供給したタミールナド[州]のHuman Biological Instituteによって製造されました。ワクチンは州のすべての公立病院で利用可能です。しかし、品質が疑惑の渦中にあるので、ワクチン使用はただちに保留されています。

Apart from civil surgeons, the copy of this letter has also been sent to the manufacturing company, director of drug controller of Tamil Nadu, deputy drug controller of India, Ghaziabad on Friday [7 Mar 2014] by the state drug control.
民間外科医とは別に、この書簡のコピーが製造会社、Tamil Nadu薬品規制局長、Ghaziabadインド薬品規制副長官に金曜日[2014年3月7日]に州薬品規制局より送られました

Victim KA, who was a student of Class-5, died while 4 others fell ill after they were administered the anti-rabies vaccines at the civil hospital in Samana on [5 Mar 2014].
All the victims were given anti-rabies injections after which they complained of drowsiness and nausea. Following the death of Ankit, Patiala drug controller visited the Samana civil hospital and took samples of the vaccine. The samples were later sent to the Central Research Laboratory at Kasauli in Himachal Pradesh [state] for testing its quality.
Samana の市民病院で [2014年3月5日]に他の4人が抗狂犬病ワクチンを接種した後に病気になった間に、クラス-5の学生だった犠牲者KAは死亡した。すべての犠牲者は、眠気や吐き気を訴えたにもかかわらず、抗狂犬病ワクチンを注射された。Ankitの死後、Patiala薬品規制官はSamana市民病院を訪れ、ワクチンのサンプルを取った。サンプルは後にその品質をテストするためにHimachal Pradesh[州]のKasauliにある中央研究所に送られた。

The health officials who visited the Rajindra Hospital in Patiala, where 4 other victims were admitted, had stated that prima facie it seems to be a case of drug reaction that occurred after anti-rabies injections were administered to the victims.
他の4人の犠牲者が入院したPatiala のRajindra 病院を訪問した保健所員は、 一見したところではそれは抗狂犬病注射を犠牲者に投与した後に発生した薬物反応例(である)と思われると述べていた。

Soon after receiving the letter from the state drug controller authorities, the pharmacists and doctors in the local civil hospital have been instructed not to administer the vaccine to anyone. Hospital officials said that [normally] around 30 anti-rabies injections were administered to dog-bite victims daily in the hospital free of cost.
The patients, who were bitten by jackals, monkeys, foxes, cats, rats and bats, are given rabies vaccine. If the course is not started in time, a patient can suffer a painful death within 48-72 hours of the bite. [Normally the incubation period for rabies is around 21 days. – Mod.MHJ]

State drug controller Ajay Singla said, “We have informed DGGI and urged it to ensure steps to stop use of the vaccine. Also, civil surgeons have been instructed not to administer vaccines to anyone into the state till the final report of the samples comes.”
州薬品統制官のAjay Singlaは“我々はDGGIに通知、ワクチンの使用を停止する手順を確実にするために、それを促してきた。また、民間の外科医は、サンプルの最終報告書が来るまで州内の誰にもワクチンを投与しないように指示されました。 “と述べた。 [Byline: Jatinder Kohli]

[If this is a first bad reaction to this vaccine at this hospital, it is more likely to be a bad batch of vaccine contaminated with some product capable of killing within hours.
If one vial is contaminated, others will be. We await clarification.

However this is not the first fatality with this company’s rabies vaccine: see 20120829.1271575. To quote my expert colleague Craig about that incident:
“The AbhyaRab vaccine is produced by Human Biological Institute. It is a purified Vero cell rabies vaccine. It is a freeze dried preparation that should be reconstituted with
0.5 mL of a diluent supplied with the vaccine. The reconstituted vaccine should be administered immediately and should not be stored for administration later. Abhayrab vaccine should be administered intra-muscularly in the deltoid region in both adults and children.
Under no circumstances should it be administered intravenously.
しかしこれは、この会社の狂犬病ワクチンの最初の惨事でない: 20120829.1271575を参照してください。その事件については私の専門家の同僚であるCraigを引用します:
AbhyaRabワクチンはHuman Biological研究所によって製造されている。精製ベロ細胞由来狂犬病ワクチンです。凍結乾燥製剤でありワクチンに付属している希釈液を0.5mL入れて戻さなければなりません。溶解されたワクチンは、直ちに投与されなければならなくて、後の投与のために保存されるべきではありません。Abhayrabワクチンは、大人と子供両方において三角筋部に筋肉内投与されるべきである。

[In the 2012 incident] the tolerance of the child to the 1st 3 inoculations followed by abrupt deterioration of his condition following the 4th administration of the vaccine suggests that there may been some error in preparation or administration of the vaccine rather than a defect in the vaccine itself. The outcome of the investigation of this incident is awaited.”
[2012年の事件で] 、最初の3回の接種に対して子供は何の反応を示さず、4回目のワクチン接種後に子供の状態が急激に悪化したのは、ワクチン自体の欠陥というよりむしろワクチンの調製あるいは投与に何らかの誤りがあったことを暗示する。この事件の調査結果が待たれる。“

To repeat Craig, “Under no circumstances should it be administered intravenously.” Maybe this is what happened here. However we should also keep the following comments in mind.
– Mod MHJ]
多分ここで何かが起こったのである。しかし我々はまた、以下のコメントに心に留めるべきです。- Mod MHJ]

[Occasionally when there is a lyophilized vaccine that requires reconstitution with a diluent, an incorrect or contaminated diluent is used and leads to adverse events following receipt of the vaccine.
This has unfortunately been seen with the childhood vaccines used by the EPI (Expanded Programme on Immunizations). Adverse reactions have ranged from local sterile or non-sterile abscesses to severe with fatal outcomes when toxic substances have been used. – Mod MPP]
これは残念ながらEPI(予防接種拡大計画)によって使用された初期の段階のワクチンで見てきた。副作用は局所の殺菌または未殺菌の膿瘍から有害物質が使用された時に致命的- (Mod MPP))な結果を伴う重症まで様々である。- Mod MPP]

[It would seem prudent  there should be an investigation as to why there was a reaction to this particular lot of vaccine. Was the entire lot of vaccine contaminated or was this a contaminated diluent affecting only one vial? How exceptionally sad to remove all vaccines in the face of a rabies out break. An investigation may reveal the reason for the reaction. The investigation may extend into drug testing the vaccine. Was a drug used as a diluent for the vaccine?
What about bacterial testing of the vaccine? Was this a reconstituted vaccine that was not held under refrigeration or held long after it should have been discarded? Bacterial swabbing of even the container may yield answers. Clearly, an investigation into this particular lot of vaccine and this particular vaccine vial is in order. – Mod.TG]
ワクチンの細菌検査はどうなのでしょうか?これが冷蔵保存されなかったか廃棄すべきなのに長期保存された再溶解ワクチンなのか?同一容器の細菌拭き取りは答えをもたらすことが出来る。明らかに、この特定のワクチンのロットとこの特定のワクチンバイアルの調査は依頼中である。- Mod.TG]