The urgent need for a safe and effective coronavirus vaccine has only increased as COVID-19 continues to spread across the country. The race to be the first to produce it has been going on for months, with biogenetic company Moderna in the final phase of its testing trial and drugmaker AstraZeneca fast-tracking its vaccine, too. But the pressure to get a vaccine out presents a serious risk, the nation’s leading immunologist, Anthony Fauci, MD, warns. He says rushing the process before a vaccine is proven to be safe and effective could gravely compromise the testing and efficacy of coronavirus vaccinations down the line. “The one thing that you would not want to see with a vaccine is getting a EUA [emergency use authorization] before you have a signal of efficacy,” Fauci said in a phone interview with Reuters on Aug. 24. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.” In other words, rushing the vaccination approval process could ultimately do more harm than good.
A EUA is commonly used for treatments that “diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product,” Fauci said. He then explained how the Food and Drug Administration (FDA) has explicit guidance on EUAs that require a treatment is both safe and effective.
This is not the first time Fauci has raised concerns about a COVID vaccine. Russia announced earlier in August that they had an effective coronavirus vaccine, which gave the director of the Nation Institute of Allergy and Infectious Disease (NIAID) pause. “I’m quite disturbed by Russia or any country which declares they have a vaccine before they’ve adequately tested it,” Fauci said during a live video interview with Bloomberg’s QuickTake on Aug. 18. “Because that would really impart upon the rest of the world if it turns out the vaccine isn’t safe.”
In an interview with Heathline on Aug. 18, Fauci shared more thoughts on rushing a COVID vaccine. “The concern that all of us have when you have any country or organization that says, ‘We have a vaccine that we’re going to start distributing to people,’ well, that’s almost impossible to do because you could not have tested adequately yet its safety and its efficacy,” he explained. He added that what Russia has is “a product that they’re willing to take the risk to give it to people without necessarily showing yet that it’s effective or that it’s safe.”
His warning in his interview with Reuters, however, came in the context of growing concern amongst scientists and public health experts that political pressure may be applied on the Food and Drug Administration (FDA) to deliver a vaccine to Americans before the general election in early November.
On Saturday, President Donald Trump alleged that “deep state” elements at the FDA were delaying approvals on vaccines until after the Nov. 3 election as a means to hurt his reelection bid. He also tagged the FDA director, Stephen Hahn, MD, in the tweet:
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
Fauci did not mention the president in his interview with Reuters, focusing instead on the science behind the testing and trial process. “To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,” he said. “We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”
During a press conference on Aug. 23, Trump announced the EUA of convalescent plasma from patients recovered from COVID-19 as a fast-tracked way to treat the coronavirus. During the press conference, FDA Director Hahn cited a Mayo Clinic study on convalescent plasma, which he has since admitted he misrepresented.
This sudden turnaround raised concerns among medical and public health experts that a vaccine could also be rushed. Peter Hotez, MD, an infectious disease expert and vaccine researcher at Baylor College of Medicine, told Reuters, “I would be very worried about using an EUA mechanism for something like a vaccine. It’s very different from plasma therapy.”
Walid Gellad, MD, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told The New York Times, “For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy.”
“That’s a problem if they’re starting to exaggerate data,” Gellad added. “That’s the big problem.”
And for more on a possible coronavirus vaccine, check out The Surprising Way You May Have to Get the Coronavirus Vaccine.