White House Won’t Block FDA Vaccine Guidelines

07.10.2020 - The administration of US president Donald Trump said on Oct. 6 it planned to override the tightening of safety precautions for Covid-19 vaccine proposed by the Food and Drug Administration (FDA) two weeks ago, over fears these could delay approval. Later in the day, it did an unexplained about-turn after the FDA published the guidelines on its own website as part of a briefing for outside vaccine advisers.

Trump has persistently pushed for a vaccine to be approved before the US elections on Nov. 3, and upon returning to the White House on Oct. 5 after three days of treatment for Covid-19 in the Walter Reed National Military Medical Center in Washington he stressed again that a vaccine would be available soon.

The Reuters news agency quoted a “senior administration official” as saying that with backing from the president’s Warp Speed initiative, at least one company will be “actively manufacturing a vaccine within the next four to six weeks”

Barring an Emergency Use Authorization (EUA) from the FDA, this would likely be administered “at risk,” both to the patient and the manufacturer, Reuters explained. These criteria were in play when the president was given a brief round of treatment with Gilead’s experimental antiviral remdesivir and a single 8-gram dose of d Regeneron’s polyclonal antibody as a precautionary measure. Neither has FDA approval.

Under the FDA’s new guidelines, vaccine makers seeking an EUA would be asked to follow participants in late-stage clinical trials for at least two months after they receive a second injection. Agency scientists would look for at least five severe cases of Covid-19 in the placebo group for each trial, as well as some cases of the disease in older people.

Former FDA commissioners sound alarm

After months of discussion over when the first vaccines would be ready and which drugmaker would be first past the post, combined with the push and shove from the White House, many Americans have grown fearful of being injected with something the FDA has not approved. But not only the public is worried.

Health officials have been sounding alarm bells, which have grown louder since Sept. 20, when Secretary of Health and Human Services (HHS), Alex Azar, stripped the FDA and other HHS agencies of the authority to sign new regulations on grounds this would minimizes litigation risk and prevent abuse of authority.

The White House has the authority to intervene in non-binding guidance such as the FDA proposals, thanks to an October 2019 executive order from Trump that gives him final authority to make or change rules, Azar asserted, however, that the changes would not affect the agency’s work on vaccines and Covid-19 treatment.

Seven former FDA commissioners, including Scott Gottlieb, predecessor of current commissioner Stephen Hahn and also a Trump appointee, were more skeptical. They criticized the administration in an open letter, arguing that political interference threatens to undermine the agency’s credibility as it prepares to approve a coronavirus vaccine.

“If the FDA makes available a safe and effective vaccine that people trust, we could expect to meaningfully reduce Covid-19 risk as soon as next spring or summer,” the authors wrote. “Without the trust that a vaccine is safe and effective, our health and economy could lag for years. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so,” they warned.

If administration officials had not backed off, reports said the FDA was planning to seek “other avenues to ensure that vaccines meet the guidelines.”  That would mean sharing the standards with an outside advisory committee of experts that would meet publicly before any vaccine is authorized for emergency use. It was unclear what will become of this proposal.


Author: Dede Williams, Freelance Journalist