The FDA is reportedly about to make approving a coronavirus vaccine before the election a lot tougher
The Food and Drug Administration is poised to roll out new, rigorous standards for an emergency approval for a coronavirus vaccine, The Washington Post reports.
The standards, which appear to be an example of the agency's efforts to increase public trust amid the politicization of vaccine development, could be unveiled as soon as this week and are expected to be much tougher than what was used for the controversial emergency clearances of potential COVID-19 treatments hydroxychloroquine and convalescent plasma, per the Post. Manufacturers will be asked to follow vaccine trial participants for at least two months after they receive their second shot, two individuals familiar with situation told the Post on condition of anonymity. The agency will also reportedly be looking for at least five severe COVID-19 cases in the placebo group for each trial, as well as some cases of the disease in older people to see if the vaccine works.
Given the new standards, plus the time it will take companies developing vaccine candidates to apply for an emergency use authorization and for the FDA to review the data, "it's hard to imagine how an EUA could possibly occur before December," Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia and FDA vaccine advisory board member, told the Post.
Subscribe to The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.
Sign up for The Week's Free Newsletters
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
From our morning news briefing to a weekly Good News Newsletter, get the best of The Week delivered directly to your inbox.
That will likely allay at least some fears that the White House will try to push a vaccine out before the November election, although there are some people who think the FDA shouldn't grant an EUA for a vaccine at all since there'd still be less safety data required for approval than under normal circumstances. Read more at The Washington Post.
Create an account with the same email registered to your subscription to unlock access.
Sign up for Today's Best Articles in your inbox
A free daily email with the biggest news stories of the day – and the best features from TheWeek.com
Tim is a staff writer at The Week and has contributed to Bedford and Bowery and The New York Transatlantic. He is a graduate of Occidental College and NYU's journalism school. Tim enjoys writing about baseball, Europe, and extinct megafauna. He lives in New York City.
-
Italian senate passes law allowing anti-abortion activists into clinics
Under The Radar Giorgia Meloni scores a political 'victory' but will it make much difference in practice?
By Chas Newkey-Burden, The Week UK Published
-
Magazine interactive crossword - May 3, 2024
Puzzles and Quizzes Issue - May 3, 2024
By The Week US Published
-
Magazine solutions - May 3, 2024
Puzzles and Quizzes Issue - May 3, 2024
By The Week US Published
-
Ukraine cheers House approval of military aid
Speed Read Following a lengthy struggle, the House has approved $95 billion in aid for Ukraine and Israel
By Peter Weber, The Week US Published
-
Myanmar: the Spring Revolution and the downfall of the generals
Talking Point An armed protest movement has swept across the country since the elected government of Aung San Suu Kyi was overthrown in 2021
By The Week Staff Published
-
Poland, Germany nab alleged anti-Ukraine spies
Speed Read A man was arrested over a supposed Russian plot to kill Ukrainian President Zelenskyy
By Peter Weber, The Week US Published
-
Israel hits Iran with retaliatory airstrike
Speed Read The attack comes after Iran's drone and missile barrage last weekend
By Peter Weber, The Week US Published
-
Is there a peaceful way forward for Israel and Iran?
Today's Big Question Tehran has initially sought to downplay the latest Israeli missile strike on its territory
By Sorcha Bradley, The Week UK Published
-
Peter Murrell: Sturgeon's husband charged over SNP 'embezzlement' claims
Speed Read SNP expresses 'shock' as former chief executive rearrested in long-running investigation into claims of mishandled campaign funds
By Arion McNicoll, The Week UK Published
-
Mark Menzies: Tories investigate MP after 'bad people' cash claims
Speed Read Fylde MP will sit as an independent while party looks into allegations he misused campaign funds on medical expenses and blackmail pay-out
By Arion McNicoll, The Week UK Published
-
Why Johnson won't just pass Ukraine aid
Speed Read The House Speaker could have sent $60 billion in military aid to Ukraine — but it would have split his caucus
By Peter Weber, The Week US Published