One-time inoculation : J & J vaccine - US authorities permit emergency use

Recently CNN.co.jp reported the following:

 Business

１回接種のＪ＆Ｊ製ワクチン、米当局が緊急使用許可

2021.02.28 Sun posted at 11:48 JST

（ＣＮＮ） 米食品医薬品局（ＦＤＡ）は２７日、米製薬大手ジョンソン・エンド・ジョンソン（Ｊ＆Ｊ）が開発した新型コロナウイルスワクチンについて、１８歳以上を対象に緊急使用許可（ＥＵＡ）を出した。

ホワイトハウスの新型ウイルス対策担当上級顧問、アンディ・スラビット氏は、米ファイザー製と米モデルナ製に続く「３番目の安全で効果的なワクチンは、歓迎すべき知らせだ」と述べた。Ｊ＆Ｊ製は接種が１回で完了し、特殊な保管設備も必要ないのが特徴だ。

２６日には第三者委員会が投票の結果、全員一致でＥＵＡを支持していた。

ワクチンはＪ＆Ｊのワクチン部門、ヤンセンが開発。米国と南アフリカ、中南米で計４万４０００人以上を対象に臨床試験（治験）が実施された。ＦＤＡの分析によると、接種後４週間以上の全体平均で中等症から重症例の予防効果は６６．１％。米国での予防効果は７２％、重症例に限れば８６％との結果が出た。

治験で副作用はほとんどみられず、あったとしても接種部位の痛みや頭痛、倦怠（けんたい）感、筋肉痛など軽い症状にとどまった。重篤な有害事象はまれで、接種後の重いアレルギー反応「アナフィラキシー」の報告はなかった。

ＦＤＡによれば、Ｊ＆Ｊ製のワクチンで症状のない感染を防げる可能性もある。

ファイザーとモデルナの予防効果が９５％前後とされるのに対し、Ｊ＆Ｊの数字が比較的低いことを懸念する声もあるが、専門家らは治験の実施時期が違ったと指摘。Ｊ＆Ｊの治験では、南アフリカで確認された症例の大半が感染力の強い新たな変異株だったと説明している。

Ｊ＆Ｊはただちに約４００万回分、３月末までには２０００万回分を出荷できると表明した。

Translation

(CNN) On the 27th, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a new coronavirus vaccine developed by the US pharmaceutical giant Johnson & Johnson (J & J) for people aged 18 and over.

Andy Slavitt, White House's the senior adviser on the new virus, said that following Pfizer and Moderna, it was "the third safe and effective vaccine and it was welcome news". The special features of J & J products were that only one injection was needed and no special storage equipment would be required.

On the 26th, a third-party committee voted unanimously to support the EUA.

The vaccine was developed by Janssen, the vaccine division of J & J. Clinical trials had been conducted in more than 44,000 people in the United States, South Africa, and Latin America. According to the FDA analysis, 4 weeks or more after vaccination, the overall average of protection from moderate to severe cases was 66.1%. In the United States, the result on preventive effect was 72%, and in severe cases it was 86%.

There were almost no side effects in the clinical trial, and even if there were, the symptoms were only mild, such as pain at the inoculation site, headache, tiredness, and muscle pain. Serious adverse events were rare, and no serious allergic reaction "anaphylaxis" was reported after vaccination.

According to the FDA, vaccines made by J & J could prevent asymptomatic infections.

Some people were concerned that the Pfizer and Moderna preventive effects were around 95%, while the J & J number was relatively low. Experts pointed out that the timing of the clinical trials was different. It was explained in  J & J clinical trials that most of the cases identified in South Africa were the new, highly infectious mutants.

J & J had announced that immediately it could ship about 4 million shipments, and a further 20 million shipments by the end of March.

              So, one special feature is noted about this vaccine: it can prevent asymptomatic infections. Such a feature was also mentioned about the vaccine made by China’s CanSinoBIO (康希诺生物). CansinoBio vaccine was said to be 68.83% effective at preventing symptomatic COVID-19 disease two weeks after a single-dose vaccination; and this rate would fall to 65.28% four weeks after one shot.