By JoNel Aleccia and Liz Szabo
As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any COVID-19 vaccine the federal agency authorizes.
But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in the Trump administration — especially now that the FDA has held firm with rules that make a risky preelection vaccine release highly unlikely.
At least six states and the District of Columbia have indicated they intend to review the scientific data for any vaccine approved to fight COVID-19, with some citing concern over political interference by President Donald Trump and his appointees. Officials in New York and California said they are convening expert panels expressly for that purpose.
Photos: Daily Life, Disrupted
“Frankly, I’m not going to trust the federal government’s opinion and I wouldn’t recommend [vaccines] to New Yorkers based on the federal government’s opinion,” New York Gov. Andrew Cuomo said last month.
“We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind,” Dr. Mark Ghaly, California’s health and human services secretary, said at a recent news conference.
“Do you really want a situation where Texas, Alabama and Arkansas are making drastically different vaccine policies than New York, California and Massachusetts?” asked Dr. Saad Omer, an epidemiologist who leads the Yale Institute for Global Health.
Separate state vaccine reviews would be unprecedented and disruptive, and a robust regulatory process already exists, said Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
“States should stay out of the vaccine review business,” Osterholm said. “I think the Food and Drug Administration is doing their job right now. Unless there’s something that changes that, I do believe that they will be able to go ahead.”
The administration has given reasons for states to worry. Trump has repeatedly signaled a desire for approval of a vaccine by the Nov. 3 election, arousing fears that he will steamroll the normal regulatory process.
The president wields “considerable power” over the FDA because it’s part of the executive branch of government, said Lawrence Gostin, faculty director of the O’Neill Institute for National and Global Health Law. The president nominates the FDA commissioner and can replace that official at any time.
Trump has already contradicted the advice of his own scientific advisers in order to promote unproven therapies to fight COVID-19. The FDA approved two treatments — hydroxychloroquine and convalescent plasma — without strong evidence of safety and efficacy after Trump pushed for the therapies to be widely available.
Late Monday, The New York Times reported that top White House officials planned to block FDA guidelines that would bolster requirements for emergency authorization of a COVID vaccine — because the new guidelines would almost certainly delay approval until after the election.
The White House’s actions undermine