WH demands FDA justify tough standards for vaccine, raising interference concerns

On the same day President Trump blasted the Food and Drug Administration’s plan for tougher standards for a coronavirus vaccine as a “political move,” a top White House aide demanded detailed justifications from the agency in what some fear is an attempt to thwart or block the standards designed to boost public trust in a vaccine.

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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…

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.

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