FDA Must Apply ‘Rigorous Standards’ to Covid Vaccine: Column

Two University of Pennsylvania Perelman School of Medicine professors say FDA must apply “rigorous standards” when considering whether to approve a coronavirus vaccine. Writing in a Washington Post op-ed, they note that “already the White House has been accused of pressuring government agencies to put politics before science when it comes to drugs to treat Covid-19. Pressure to move quickly on a vaccine will be intense, and at some point FDA will be asked to authorize a vaccine candidate for widespread use. Although FDA could allow use of a coronavirus vaccine based on weak evidence, it must not make that mistake.”

The opinion piece goes on to discuss FDA use of its emergency use authorization (EUA) power over the years and during the current public health emergency. More than 150 EUAs have been approved for Covid-19, more than the total number issued before the pandemic, it says. Most of the EUAs have been for tests, although they’ve also include personal protective equipment, ventilators, and drugs such as hydroxychloroquine, chloroquine, and remdesivir.

The authors say the risk/benefit tradeoffs for products treating disease are very different from those for products intended to prevent the disease rather than treat it. They note that FDA has used this pathway for a vaccine only in 2005 to allow a decades-old vaccine to be used to prevent anthrax in a bioweapon attack.

According to the story, while emergency treatments may be given to thousands or tens of thousands of very sick patients, a vaccine could reach millions and even tens or hundreds of millions of healthy people.

“Because vaccine recipients are not sick, their potential to benefit stands to be much less than that of seriously ill patients given a drug, especially in light of the effectiveness of alternatives such as physical distancing and good hygiene,” the professors write. “If data ultimately show that vaccine effectiveness is limited while the risks are substantial, harms to millions of uninfected individuals could be enormous. False reassurances from a flawed vaccine might also worsen the epidemic, setting back progress.”

The article also says that public trust in vaccines is another critical consideration. “Already, the anti-vaccine movement has begun to sow doubt about a coronavirus vaccine,” it says. “Even if an option ultimately proves to be safe and effective, it won’t do much good if many people refuse it. And if a Covid-19 vaccine causes harm, efforts to counter other vaccine-preventable diseases may be set back as well.”

The authors conclude that FDA must not authorize a vaccine until data from a well-controlled trial demonstrates that it can prevent Covid-19 and that it is safe enough to give to millions of people.