Marysville Appeal-Democrat

Signs of an ‘October vaccine surprise’ alarm career scientists

- Kaiser Health News (TNS)

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administra­tion and even vaccine manufactur­ers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasur­e with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administra­tion, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care

Act, to inject politics into sensitive public health decisions. Trump has repeatedly contradict­ed the advice of senior scientists on COVID-19 while pushing controvers­ial treatments for the disease.

If the executive branch were to overrule the FDA’S scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensifie­d over the weekend, after Alex Azar, the administra­tion’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokespers­on Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternativ­ely, Azar – who reports directly to Trump

– can issue an emergency use authorizat­ion, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politicall­y,” said Dr.

Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of

Medicine. He said it “seems frightenin­gly more plausible each day.”

Vaccine experts and public health officials are particular­ly vexed by the possibilit­y because it could ruin the fragile public confidence in a COVID-19 vaccine.

It might put scientific authoritie­s in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’S objections is prepostero­us and betrays ignorance of the transparen­t process that we’re following for the developmen­t of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

 ?? Getty Images/tns ?? From left, Health and Human Secretary Alex Azar, U.S. President Donald Trump listen as Moncef Slaoui, the former head of Glaxosmith­klines vaccines division, speaks about coronaviru­s vaccine developmen­t in the Rose Garden of the White House on May 15 in Washington, D.C.
Getty Images/tns From left, Health and Human Secretary Alex Azar, U.S. President Donald Trump listen as Moncef Slaoui, the former head of Glaxosmith­klines vaccines division, speaks about coronaviru­s vaccine developmen­t in the Rose Garden of the White House on May 15 in Washington, D.C.

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