The fear is well-founded: In the U.S., politics already appears to be scrambling the approval of Covid-19 treatments. First, there was the hydroxychloroquine embarrassment. Then, in August, the FDA issued an emergency use authorization for a promising but unproven coronavirus treatment after Trump accused the agency of slow-walking the approval to hurt his reelection chances.
But the big prize for the White House will be a vaccine. Earlier this month, Trump blamed “the deep state, or whoever, over at the FDA” for “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.” The president “had to make sure that they felt the heat,” Trump’s chief of staff, Mark Meadows, explained. The Financial Times then reported that the Trump administration is considering fast-tracking approval of the Oxford vaccine if results from a 10,000-person late-stage clinical trial look promising, even though the FDA has said any vaccine seeking approval for use in the U.S. will need to show positive results in clinical trial of at least 30,000 people. (AstraZenenca said it had not discussed emergency use with the Trump administration.)
These are not trivial differences. Successful vaccines take time, and painstaking attention to detail. Sometimes important safety and efficacy concerns don’t emerge until the late stages. The ongoing Phase III trials will already be much shorter than the norm for vaccines, lasting months rather than years.
Rushing out a vaccine without solid proof it works could turn the public against it, leaving Americans without a valuable tool in fighting Covid-19. Worse, it could do harm. “A medicine will eventually wash out of your system. So if there are any toxicities, they will eventually wash out,” Kinch says. “A vaccine is meant to train the immune system to do something that will hopefully continue for the rest of the person’s life. If that thing happens to be bad, then the problem is lifelong.”
Offit remembers, when he was developing his vaccine, the FDA took a full year “to validate every aspect of the process, right down to cleaning the vats at the end.” “I’d like to believe that the FDA is holding the manufacture of Warp Speed to what they hold every vaccine-maker to do,” he says. “Because we don’t know. Warp Speed is a little bit of a black box.”
Top U.S. health officials have been trying to quell these fears, even as Trump continues to stoke them. FDA Chief Stephen Hahn, a Trump appointee, insists that the agency will only approve a safe, effective vaccine. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, says he would resign if it doesn’t.
Food and Drug Administration commissioner Stephen Hahn speaks during a media briefing in the White House on Aug. 23, 2020, in Washington. | Alex Brandon/AP
But the fears aren’t going away, especially not without more transparency into exactly how vaccine approval will work, and who will make the final call. “The administration has been willing to perturb science,” says Offit, “whether it’s the EPA or the FDA with hydroxychloroquine or the National Weather Service with Hurricane Dorian.” How can the world have faith the administration won’t do it again, simply because a rival appears to have gotten there first?
Fidler thinks it’s too much to hope that geopolitics can stop interfering with public health. The current clash between the U.S. and China means the era of U.S.-led altruistic health initiatives done without the motivation of power over a rival, like President George W. Bush’s PEPFAR program to fight infectious diseases in Africa, is over. Today, great powers will try to press their advantage in whatever ways they can.
But China and the U.S. can try to keep the competition from spiraling out of control and destroying public health in its wake. In past eras of multipolar rivalry, antagonists have been able to set limits to that competition, singling out certain areas in which they can turn down the heat and cooperate a bit more. The U.S. and China could do that today, Fidler suggests, perhaps by agreeing to take their hands off the WHO.
That needs to happen soon. Because right now, nothing is off-limits—which means neither is the destruction of decades worth of public health norms.
“If we don’t have some sort of global health détente between Beijing and Washington,” warns Fidler, “we’re in real trouble.”