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MEMORANDUM

India

642回目:コバクシン

インド初の新型コロナワクチン承認

インドの薬品規制当局は3日、同国で開発された初の新型コロナウイルスワクチンの緊急使用を承認した。

インドでは、米国に次ぎ世界で2番目に多い累計1000万人超がコロナに感染し、15万人近くが死亡。

後発医薬品(ジェネリック)製造大国でもあるインドで国産ワクチンの製造が軌道に乗れば、新興国や途上国のワクチン普及にも希望となりそうだ。

承認されたのは、インドの医薬品メーカー、バーラト・バイオテックが開発した不活化ワクチンの「コバクシン」。

2~8度での保存が可能で、2回の接種が必要だという。

昨年12月からの最終段階の臨床試験(治験)で2万2500人が接種し、「安全性が確認された」(インド保健・家族福祉省)としている。  

合わせて、英製薬大手アストラゼネカと英オックスフォード大が開発したワクチンも承認した。

アストラゼネカのワクチンは、超低温管理が必要な米製薬大手ファイザーなどのワクチンに比べて管理しやすく、価格も安いとされている。

開発には政府系のインド医学研究評議会(ICMR)も関わった。モディ首相は同日、ワクチン承認を「決定的なターニングポイントだ」とツイッターに投稿し、称賛した。

インドではCovishieldとして知られるオックスフォード-アストラゼネカワクチンは、世界最大のワクチンメーカーであるセラムインスティテュートオブインディアによって生産されており、4,000万から5,000万回分を備蓄しており、7月までに3億回分を生産する予定で、その生産の50%をインド向けに約束した。

オックスフォード-アストラゼネカの研究者が発表した中間結果は、ワクチンの2回の投与で62%有効であることを示した。

Jan 3rd Washington post

NEW DELHI — India granted emergency approval Sunday to its first vaccines — Oxford-AstraZeneca and homegrown Covaxin — as it prepares to undertake an unprecedented immunization program for the country of more than 1.3 billion.
The announcement of India's approval of the Oxford-AstraZeneca vaccine came days after regulators in Britain greenlighted it and marks a big step for the country that is the world's second-worst affected by the coronavirus pandemic. India aims to administer the vaccine to 300 million people in the first phase, and distribution could begin in the coming days.
The Oxford-AstraZeneca vaccine, known as Covishield in India, is being produced locally by the Serum Institute of India, the world’s largest vaccine manufacturer. It has stockpiled 40 million to 50 million doses and plans to produce 300 million doses by July. Its billionaire owner, Adar Poonawalla, has pledged 50 percent of its production for India. On Sunday, Poonawalla said on Twitter that his company’s risks had “paid off” and that the vaccine is “ready to roll-out.”
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Interim results published by Oxford-AstraZeneca researchers in the United Kingdom showed that the vaccine was 62 percent effective among those given two doses. A different dosage proved 90 percent effective; scientists are actively studying that dosage and its efficacy. Pfizer-BioNTech and Moderna, which have rolled out vaccines in the United States, reported efficacy rates of about 95 percent.
According to a statement by the Indian drug regulator, the Serum Institute conducted Phase 2 and 3 trials on 1,600 participants in the country, and the data was found to be “comparable” with the data from overseas studies. The approval is subject to regulatory conditions, though details of those were not shared immediately.
Prime Minister Narendra Modi said it was a matter of pride for every Indian that both vaccines are “made in India.”
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But the announcement was marred by questions about the fast-track approval of Covaxin, which has not completed its third phase of human clinical trials. That vaccine is being developed by Hyderabad-based Bharat Biotech in collaboration with two government-backed institutes. The regulator said the trials for the first two phases demonstrated the vaccine was safe, but it did not share efficacy data.
“Detailed analysis documents need to be put in the public domain,” said Giridhar Babu, a public health expert, adding that terms like “restricted use” in the announcement need to be explained.
“Regulatory conditions need to be spelled out much more clearly,” he said.
Shashi Tharoor, a member of the opposition party in the Indian Parliament, tweeted that the approval of Covaxin was “premature and could be dangerous.”

-India
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