Trump, White House demand FDA justify tough standards for coronavirus vaccine, raising concerns of political interference

The White House’s involvement appears to go beyond the perfunctory review that agency officials had expected, and is likely to reinforce public concerns that a vaccine may be rushed to benefit the president’s reelection campaign. Polls show that the number of people who say they’re willing to take a coronavirus vaccine if it were available today has nosedived from 72 percent in May to 50 percent as of early this month, according to Pew Research Center, largely because of concerns that politics, rather than science, is driving the process.

Trump has repeatedly said a vaccine would be available by Election Day, or possibly sooner, worrying scientists that he might attempt to intervene in the review process. Companies will begin reporting safety and effectiveness data in coming weeks and months. And in conversations with some advisers, the president has directly tied the vaccine to his reelection chances, according to a senior administration official, who spoke on the condition of anonymity to discuss private deliberations.

The White House’s decision to weigh in on the FDA plan was assailed by former FDA commissioners who had served both Republican and Democratic presidents.

“I don’t know of any precedent where the White House asked to adjudicate scientific and clinical guidances, even in past public health emergencies,” said Scott Gottlieb, Trump’s first FDA commissioner. “To build trust among patients and providers, you wanted to leave these matters to the FDA process, which has a lot of rigor and integrity.”

Robert Califf, commissioner under President Barack Obama, said White House officials lack the expertise to assess the FDA’s safety protocols. “For the president to weigh in is not good,” he said, “and it sets a precedent, which is worrisome in many regards, and makes you worry about what he’ll do about the decision itself about individual vaccines.”

The push from the White House comes during a week in which top health administration officials, including FDA Commissioner Stephen Hahn, vowed there would be no political interference in the vaccine approval process and sought to boost public trust in the process.

So far, the White House has not asked the FDA to withdraw or change the guidance for an emergency authorization of the vaccine — a far quicker process than a formal approval that gives the FDA the flexibility to set a lower bar for safety and effectiveness. The agency expects to use the process because of the urgency of the situation. In a Wednesday phone call, White House Chief of Staff Mark Meadows told Hahn the agency had to provide the detailed justification for the guidance, according to two people familiar with the call who spoke on the condition of anonymity to discuss internal deliberations.

The FDA, which had planned to release the guidance this week, instead has been working on detailed scientific justifications for the questions raised by White House officials, according to two people who spoke on the condition of anonymity to discuss internal deliberations. White House officials are especially interested in the agency’s recommendation

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