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.
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.
-
Trump lambasts crime, but his administration is cutting gun violence prevention
The Explainer The DOJ has canceled at least $500 million in public safety grants
-
Florida erases rainbow crosswalk at Pulse nightclub
Speed Read The colorful crosswalk was outside the former LGBTQ nightclub where 49 people were killed in a 2016 shooting
-
New York court tosses Trump's $500M fraud fine
Speed Read A divided appeals court threw out a hefty penalty against President Trump for fraudulently inflating his wealth
-
Trump halts Gaza visas as Israelis protest war
Speed Read Laura Loomer voiced her concerns over injured Palestinian kids being brought to the US for treatment and a potential 'Islamic invasion'
-
Russia tries Ukraine land grab before Trump summit
Speed Read The incursion may be part of Putin's efforts to boost his bargaining position
-
US, China extend trade war truce for 90 days
Speed Read The triple-digit tariff threat is postponed for another three months
-
Europe counters Putin ahead of Trump summit
Speed Read President Trump will meet with Russian President Vladimir Putin in Alaska this week for Ukraine peace talks
-
Israeli security cabinet OKs Gaza City takeover
Speed Read Netanyahu approved a proposal for Israeli Defense Forces to take over the largest population center in the Gaza Strip
-
How China uses 'dark fleets' to circumvent trade sanctions
The Explainer The fleets are used to smuggle goods like oil and fish
-
Thailand, Cambodia agree to ceasefire in border fight
Speed Read At least 38 people were killed and more than 300,000 displaced in the recent violence
-
Israel 'pauses' Gaza military activity as aid outcry grows
Speed Read The World Health Organization said malnutrition has reached 'alarming levels' in Gaza