Would the U.S. approve a COVID-19 vaccine before we know if it’s safe?

coronavirus vaccine safety fda
Photo via Jernej Furman/Flickr (CC BY 2.0)
  • A vaccine could receive authorization before clinical trials are finished
  • Some wonder if politics is at the heart of the matter
  • Experts are worried about employing such a vaccine

Food and Drug Administration Commissioner Dr. Stephen Hahn said in an interview in the Financial Times that the FDA is open to issuing an emergency use authorization (EUA) for a COVID-19 vaccine before it finishes its phase 3 clinical trials. That’s led people to wonder whether coronavirus vaccine safety is being disregarded in favor of a speedy solution to the pandemic. 

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said. “If they do that before the end of phase 3, we may find that appropriate. We may find that inappropriate, we will make a determination.”

Typically, vaccines must pass through three clinical trial phases before its developers can apply for approval and licensure from the FDA. The History of Vaccines explains that phase 3 is the first time thousands of people receive the vaccine, testing it for efficacy and unexpected side effects.  

An EUA from the FDA typically allows a specific demographic of people to get the unlicensed vaccine outside of a clinical trial, such as healthcare workers or the elderly—not necessarily the whole population. In this case, Hahn said it’s more likely to allow a defined population to get the vaccine before approval. 

“Our emergency use authorization is not the same as a full approval,” Hahn said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”

According to Science Mag, a senior official at the Department of Health and Human Services said a EUA approval for a vaccine would “be based on data reviewed by the independent boards,” which was “set up by the vaccine’s sponsors or clinical trial investigators.” 

A vaccine will only receive the EUA if the FDA confirms “95% confidence that efficacy is no lower than 30%,” the magazine wrote. 

Some health experts are not in favor of approving a EUA before the end of phase 3 clinical trials, and at least three state officials have said they wouldn’t distribute the vaccine if they felt it wasn’t safe. Dr. Angela Rasmussen, a virologist at New York’s Columbia University, spoke out against the EUA on Twitter.   

“If a vaccine isn’t safe, it could harm all the people who take it,” she wrote. “Even if it is safe, but isn’t effective, it could indirectly harm people by giving them a false sense of security that they are protected. Both situations would be extraordinarily damaging to public health.”

Some worry that coronavirus vaccine safety is being mixed with politics

Health experts are particularly concerned that if the public perceives the vaccine development process is rushed, then more people will be unwilling to get inoculated when it becomes widely available. Already a Gallup poll shows that 35% of Americans would not get a COVID-19 vaccine. 

Americans are partly concerned that the FDA would only approve a EUA for a vaccine because of President Trump’s pressure to fast-track a vaccine before the November election, possibly eschewing coronavirus vaccine safety in the meantime. 

This wouldn’t be the first time the FDA gave a controversial EUA to a COVID-19 treatment criticized by health experts. The FDA initially gave an emergency authorization to use hydroxychloroquine to treat COVID-19 patients after Trump touted his support. The administration later had to revoke the EUA

More recently, the FDA has been criticized for issuing a EUA to use convalescent plasma treatment, another method supported by Trump that doesn’t have full agreement in the science community. Hahn had to apologize after saying the treatment could save 35 lives out of every 100 patients when studies said it was only 3-5 lives. 

But in the interview with the Financial Times, Hahn assured that whether a vaccine receives a EUA will have nothing to do with politics. 

“We have a convergence of the COVID-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles,” Hahn said. “This is going to be a science, medicine, data decision. This is not going to be a political decision.”

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Sources: Financial Times, History of Vaccines, Science Magazine, Gallup, The Guardian

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