Trump suggests he may overrule FDA vaccine approval
President Donald Trump has fanned new concerns over the politicization of coronavirus vaccine approvals, suggesting he could block stricter guidance from the U.S. Food and Drug Administration (FDA) in order to expedite a treatment to the general public.
As the U.S. faces a second wave of COVID-19 cases ahead of the flu season, two leading vaccine candidates are making their way through late-stage clinical trials. The need for a successful cure is high, as the world’s largest economy struggles to control nearly 7 million diagnoses and over 200,000 deaths. Globally, almost 32 million have been infected and more than 677,000 have died.
At a Senate hearing on Wednesday, FDA Commissioner Stephen Hahn repeated assurances that the agency would stick to usual standards of review of data and information in order to grant a limited emergency use authorization.
The FDA is in the process of expanding the observation period of Phase 3 trials, and the new guidance would push out an authorization toward the end of November, rather than the possible earlier timeframe of late October that is currently in sight.
The agency “will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness,” Hahn said. He added that “every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics.”
However, Trump undercut the FDA chief in press remarks later Wednesday, criticizing the new guidelines as unnecessary, and suggesting the agency itself was playing politics.
“We’re looking at that and that has to be approved by the White House. We may or may not approve it. That sounds like a political move,” Trump said.
U.S. Health and Human Services (HHS) Sec. Alex Azar similarly undercut the FDA Thursday, telling NBC the rules the FDA is pursuing already exist.
Trump has insisted a vaccine is likely to be approved by Election Day, even as all top health officials have suggested that it would take longer for a treatment to be available to the general public. At best, the two top contenders could have the first read of efficacy data by that time, with any sort of authorization comings weeks to months after.
Meanwhile, as concerns percolate over the impact of school reopenings, a new study suggested that some of those fears may be unfounded. While there have been reports of spikes in cases at colleges, grade schools have not seen such spikes, early data show. The rate of spread has been lower than expected inside buildings, and come mostly from external activities instead.
The results come as the debate over physical attendance in schools grows more acute, with New York City still trying to decide whether children will attend in person classes this year. In Wisconsin, officials warn parents are sending coronavirus-infected kids to school, all while lying to contact tracers and refusing tests.
Separately, Missouri’s Republican governor Mike Parson, who has refused to mandate masks, has tested positive for the virus. The governor said he feels no symptoms but is adhering to quarantining procedures.
Test before you fly
As the world faces a second wave of the coronavirus, airlines like United (UAL) and Lufthansa (DLAKY) are looking at pre-flight COVID-19 testing in order to encourage more travelers to take to the skies.
The industry has been under sever pressure, with as much as an 82% drop in international travel compared to last year.
It’s why airlines and even some airports have begun offering testing. Newark Liberty International Airport offers tests in one of its terminals, and European airports are piloting a self-test developed in Israel as the continent faces new outbreaks.
In the U.S., where second wave fears are on the rise, the need for testing has been hampered by regular shortages of necessary equipment — even as the FDA continues to approve new tests. U.S. Centers for Disease Control and Prevention (CDC) director Robert Redfield said Wednesday that more than 90% of individuals have not had the virus — even though some areas, like New York City, has seen at least 22% of its population affected.
Most recently, an antibody test authorized for emergency use in July was reauthorized to include point-of-care fingerprick testing. The new authorization increases the potential use settings.
“As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests,” the FDA’s Hahn told lawmakers on Wednesday.
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