Top Vaccine Official Says He’ll Resign If FDA Caves To Political Pressure

In this handout photo released by the University of Oxford a doctor takes blood samples for use in a coronavirus vaccine trial in Oxford, England, Thursday June 25, 2020. Scientists at Oxford University say their exp... In this handout photo released by the University of Oxford a doctor takes blood samples for use in a coronavirus vaccine trial in Oxford, England, Thursday June 25, 2020. Scientists at Oxford University say their experimental coronavirus vaccine has been shown in an early trial to prompt a protective immune response in hundreds of people who got the shot. In research published Monday July 20, 2020 in the journal Lancet, scientists said that they found their experimental COVID-19 vaccine produced a dual immune response in people aged 18 to 55. British researchers first began testing the vaccine in April in about 1,000 people, half of whom got the experimental vaccine. (John Cairns, University of Oxford via AP) MORE LESS
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The country’s top career official in charge of approving a COVID-19 vaccine said that he would resign from his position if he felt that the approval process had been politically compromised, Reuters reported on Thursday.

Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, reportedly said on a conference call last week held by the National Institutes of Health that he would resign if an ineffective or unsafe vaccine was pushed through

“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks later confirmed to Reuters. “I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”

Marks is the official in charge of determining that there’s enough evidence showing that a COVID-19 vaccine is safe and effective to allow an emergency use approval. A Star Trek fan, Marks came up with the name for Operation Warp Speed, the Trump administration’s effort to accelerate vaccine development for mass production by January 2021.

But Marks’s remarks come as the starkest example of fear that President Trump will push for an unproven vaccine to be approved before the November election. Trump said on Aug. 6 that he wanted a vaccine to be approved “right around” Election Day, while Operation Warp Speed officials have said that they’re planning to “overwhelm” the airwaves with vaccine messaging by November.

The concern partly comes down to the nature of the vaccine trials that are ongoing and the severity of the disease’s spread. The trials rely on participants getting infected in the real world, with researchers comparing outcomes between a vaccinated and a placebo group. Since the failure to control the pandemic virtually guarantees that many participants will be infected quickly, some have expressed concern over a scenario where a vaccine is known to be effective, but not necessarily safe.

Dr. Paul Offitt, a member of the FDA’s vaccine advisory committee, expressed concern to TPM that the Trump administration would approve a vaccine in such a situation.

“Who are they relying on to make this decision? Are they relying on [FDA commissioner] Stephen Hahn? A committee?” Offit asked. “The committee that makes these decisions is the vaccine advisory committee. They’re usually the one to make a recommendation.”

In June, scientists at the CDC’s vaccine committee needled an Operation Warp Speed official over concerns that the Trump administration would leave them out of the loop.

Dr. Beth Bell, head of the committee’s COVID-19 working group, said that she hoped the Trump administration would include the CDC in the decision-making process.

Dr. Bell told Operation Warp Speed official Dr. Matthew Hepburn that her committee has played a role in vaccines “for decades and decades” with a “well-oiled and highly respected process for taking scientific information as it becomes available and using it to develop policies that are evidence based.”

Hepburn replied that he was “all in favor of continuing the dialogue. Just let me know.”

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