White House blocks FDA guidance that may have ensured no Covid-19 vaccine is okayed before election day: Report
President Donald Trump said in September that the White House may or may not approve any new stricter guidelines issued by the US Food and Drug Administration (FDA) for the authorization of a Covid-19 vaccine. According to latest reports, new guidance for the emergency use authorization of a Covid-19 vaccine by the FDA — including one that may ensure that no coronavirus vaccine is authorized before the presidential election on November 3 — is being blocked by the White House.
“The FDA submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely,” reports the New York Times (NYT).
At issue is the FDA’s recommendation that volunteers in ongoing clinical trials be followed for two months after the final dose is administered to make sure the vaccines are safe and effective enough to receive emergency approval. “Given where the clinical trials stand, that two-month follow-up period would all but preclude any emergency clearance before election day. The conflict began almost as soon as the FDA submitted the guidelines to the White House budget office on September 21,” according to the NYT. It adds, “Meadows questioned the need for two months of follow-up data, said that stricter recommendations would change the rules in the middle of clinical trials and suggested that Dr (Stephen) Hahn (FDA commissioner) was overly influenced by his agency’s career scientists.”
According to the Associated Press (AP), a senior administration official explained that the White House believed there was “no clinical or medical reason” to add additional screening protocols. The official eportedly said that the White House was “intent on getting a safe vaccine to market and wanted to make sure additional loopholes weren’t added that would slow down the process”. Trump has repeatedly announced that a vaccine would be ready by November 3. After reports emerged that the FDA may be considering tougher guidelines for the emergency authorization of a Covid-19 vaccine, the president told reporters that his administration is looking into the matter, adding that such a proposal would appear political.
“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 because when you have Pfizer, Johnson & Johnson, Moderna, these great companies coming up with these — the vaccines, and they’ve done testing and everything else, I’m saying, ‘Why would they have to be, you know, adding great length to the process?’” stated Trump last month. He added, “The vaccine is very important. I believe it’s going to be the final step. And no, we’re looking at that, but I think it’s — I think that was a political move more than anything else.”
A day after he made these comments, the presidents of the National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) issued a statement, criticizing political interference in science. “Any efforts to discredit the best science and scientists threaten the health and welfare of us all,” they warned. FDA Commissioner Stephen Hahn also assured last month that science will guide the decisions of the agency. “Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA through our thorough review processes and science will guide our decisions. FDA will not permit any pressure from anyone to change that,” he said.
Meanwhile, an administration official told Reuters that the approval process was still pending and denied any election day connection. According to NYT, the FDA is exploring other avenues to ensure that vaccines meet the guidelines. “That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction,” it suggests.