President Trump and FDA commissioner Stephen Hahn. Photo: Pete Marovich/Getty Images

The Food and Drug Administration plans to toughen the requirements for a coronavirus vaccine emergency authorization, which would make it more difficult for one to be ready by the election, the Washington Post reported Tuesday.

Why it matters: Public skepticism of an eventual vaccine keeps increasing as President Trump keeps making promises that are at odds with members of his own administration.

  • This skepticism is bad. A rushed, unproven vaccine would be even worse.

Driving the news: The new FDA guidance would be much more rigorous than what was used to provide emergency authorization to hydroxychloroquine or convalescent plasma. Both authorizations were controversial.

  • The agency is expected to ask vaccine manufacturers to monitor late-stage clinical trial participants for a median of at least two months, beginning after the participants receive their second shot.
  • It will also be looking for at least five severe coronavirus cases in each trial's placebo group, along with cases in older people, to further indicate that the vaccine works.

Between the lines: The new standards, combined with other elements of the authorization process, would make it very unlikely than any vaccine will be ready for administration before Nov. 3.

The other side: Some critics say that an emergency authorization — versus a full approval — shouldn't be used at all for a vaccine.

  • "Things are so revved up right now that there is quite a possibility that the American public won't accept a vaccine because of all the things that are going on," Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the Post.

What they're saying: "The FDA has previously noted that the agency intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA," the agency said in a statement.

Go deeper

How the coronavirus pandemic could end

Illustration: Sarah Grillo/Axios

It's still the early days of the coronavirus pandemic, but history, biology and the knowledge gained from our first nine months with COVID-19 point to how the pandemic might end.

The big picture: Pandemics don't last forever. But when they end, it usually isn't because a virus disappears or is eliminated. Instead, they can settle into a population, becoming a constant background presence that occasionally flares up in local outbreaks.

The pandemic is getting worse again

Expand chart
Data: The COVID Tracking Project, state health departments; Note: Due to a database error, Missouri had a 3 day gap in reporting from Oct. 11-13; Map: Andrew Witherspoon/Axios

Every available piece of data proves it: The coronavirus pandemic is getting worse again, all across America.

The big picture: As the death toll ticks past 212,000, at a moment when containing the virus ought to be easier and more urgent than ever, we are instead giving it a bigger foothold to grow from.

Updated 17 hours ago - World

France becomes 2nd Western European country to top 1M coronavirus cases

French President Emmanuel Macron at the Seine Saint Denis prefecture headquarters in Paris, on Tuesday. Photo: Ludovic Marin/POOL/AFP via Getty Images

France has become the second country in Western Europe to surpass 1 million COVID-19 cases, Johns Hopkins University data shows

The big picture: France had reported 1,000,369 cases and 34,075 deaths from the coronavirus by Thursday morning, per JHU. French President Emmanuel Macron declared a state of health emergency and imposed a curfew on virus hot spots earlier this month. Spain on Wednesday became the first Western European nation to top 1 million cases.

Get Axios AM in your inbox

Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

Please enter a valid email.

Subscription failed
Thank you for subscribing!