The fear is well founded: in the United States, politics already seem to cloud the approval of Covid-19 treatments. First, there was the embarrassment of hydroxychloroquine. Then, in August, the FDA issued emergency use approval for a promising but unproven treatment for the coronavirus after Trump accused the agency of slowing approval to hurt his chances of re-election.
But the White House’s big price will be a vaccine. Earlier this month, Trump blamed the “deep state, or whoever, the FDA” for “making it very difficult for drug companies to get people to test vaccines and therapeutics.” Obviously, they are hoping to delay the response until November 3. The president “had to make sure they felt the heat,” Trump chief of staff Mark Meadows explained. the Financial Times then reported that the Trump administration was planning to quickly approve the Oxford vaccine if the results of an advanced 10,000-person clinical trial look promising, even though the FDA said any vaccine seeking approval for use in the United States should show positive results in a clinical trial of at least 30,000 people. (AstraZenenca said it has not discussed emergency use with the Trump administration.)
These are not trivial differences. Effective vaccines take time and careful attention to detail. Sometimes, significant safety and efficacy issues do not appear until the later stages. The ongoing Phase III trials will already be much shorter than the norm for vaccines and last for months rather than years.
Rushing for a vaccine without solid proof of its effectiveness could turn the public against it, leaving Americans without a valuable tool to fight Covid-19. Worse yet, it could hurt. “Eventually, a drug will flush your system. So if there are toxicities, they will eventually go away, ”says Kinch. “A vaccine aims to train the immune system to do something that will hopefully continue for the rest of a person’s life. If this thing is bad, then the problem is lifelong. “
Offit recalls that when it was developing its vaccine, the FDA took a full year “to validate every aspect of the process, until the tanks are cleaned at the end.” “I would like to believe that the FDA limits the manufacture of Warp Speed to what it asks of each vaccine manufacturer,” he says. “Because we don’t know. Warp Speed is a bit of a black box. “
Senior U.S. health officials have tried to allay those fears, even as Trump continues to stoke them. Trump-appointed FDA chief Stephen Hahn insists the agency will only approve a safe and effective vaccine. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, says he would step down if he didn’t.
But the fears don’t go away, especially not without more transparency on exactly how vaccine approval will work and who will make the final call. “The administration has been set to disrupt science,” Offit says, “whether it was the EPA or the FDA with hydroxychloroquine or the National Weather Service with Hurricane Dorian. How can the world believe that the administration will not start over, just because a rival seems to have arrived first?
Fidler thinks it’s too much to hope that geopolitics can stop interfering with public health. The current clash between the United States and China means that the era of selfless health initiatives led by the United States without the motivation of power over a rival, like President George W. Bush’s PEPFAR program to combat infectious diseases in Africa are over. Today, the great powers will try to exercise their advantage in every way possible.
But China and the United States can try to prevent competition from spiraling out of control, destroying public health in its wake. In past eras of multipolar rivalry, antagonists have been able to set limits on this competition, identifying certain areas where they can lower the pressure and cooperate a bit more. The United States and China could do so today, suggests Fidler, perhaps agreeing to take their hands off the WHO.
It must happen soon. Because right now nothing is banned – which also means destroying decades of public health standards.
“If we don’t have some sort of global easing of health between Beijing and Washington,” Fidler warns, “we’re really in trouble.”