コロナワクチン治験、参加者に初の死者　ブラジル

【リオデジャネイロＡＦＰ＝時事】ブラジル当局は21日、英国のオックスフォード大学と製薬大手アストラゼネカが共同開発する新型コロナウイルスワクチンの臨床試験（治験）に参加していた男性が死亡したと発表した。報道によると男性は、開発中のワクチンではなく、プラセボ（偽薬）を投与されていたという。（写真は資料写真）
　新型コロナウイルスのワクチン治験は世界各地で行われているが、参加者の死亡が報告されたのはこれが初めて。
　オックスフォード大学とアストラゼネカは、安全性への懸念はないとの独立委員会の判断を受けて治験は続行すると発表した。
　報道によると、男性は新型コロナウイルス感染症（ＣＯＶＩＤ-１９）流行の最前線で働いていた２８歳の医師で、ＣＯＶＩＤ-１９による合併症で死亡したという。
　ブラジル有力紙グロボとブルームバーグは、この治験に詳しい情報筋の話として、男性は開発中のワクチンではなくプラセボを投与されるグループに属していたと報じた。
　オックスフォード大学とアストラゼネカは９月、英国の治験参加者１人に原因不明の症状が出たため、治験を中断。その後、英国の規制当局と独立調査委員会がこの症状はワクチンの副作用ではないと結論づけ、治験は再開された。
　死亡した男性の遺族と友人はグロボ紙に対し、男性は昨年医学部を卒業し、新型コロナウイルスに感染する前は健康だったと述べた。【翻訳編集ＡＦＰＢＢＮｅｗｓ】
〔ＡＦＰ＝時事〕（2020/10/22-17:15）

A volunteer participating in clinical trials of the Covid-19 vaccine developed by Oxford University has died in Brazil, officials said Wednesday, though it was unclear whether he received the vaccine or a placebo.
It is the first death reported in the various coronavirus vaccine trials taking place worldwide.
However, organizers of the study said an independent review had concluded there were no safety concerns and that testing of the vaccine, developed with pharmaceutical firm AstraZeneca, would continue.
Media reports said the volunteer was a 28-year-old doctor working on the front lines of the pandemic who died of complications from Covid-19.
All significant medical incidents, whether participants are in the control group or the Covid-19 vaccine group, are independently reviewed, Oxford said in a statement.
Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial, and the independent review in addition to the Brazilian regulator have recommended that the trial should continue.
National health regulator Anvisa confirmed it had been formally notified of the case on October 19 and had received a report on the independent review from the security and evaluation committee overseeing the study.
The D'Or Teaching and Research Institute (IDOR), which is helping organize the tests in Brazil, said the independent review process had raised no doubts about the safety of the study, and recommended it continue.
Oxford and AstraZeneca previously had to suspend testing of the vaccine in September when a volunteer in Britain developed an unexplained illness.
Trials resumed after British regulators and an independent review concluded the illness was not a side effect of the vaccine.
Half the volunteers in the final-stage clinical trial -- a double-blind, randomized, controlled study -- receive a placebo, IDOR said.
Around 8,000 volunteers have been vaccinated so far in Brazil, and more than 20,000 worldwide, it said.
Study participants must be doctors, nurses or other health sector workers who come into regular contact with the virus.
Brazilian newspaper Globo said the deceased volunteer was a young doctor who had been treating Covid-19 patients since March in the emergency rooms and intensive care units at two hospitals in Rio de Janeiro.
He graduated from medical school last year, and was in good health prior to contracting the disease, family and friends told the newspaper.