Trump, White House want FDA to justify tough rules for vaccine
WASHINGTON — On the same day President Donald 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.
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 re-election 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.
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.
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.
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. White House officials are especially interested in the agency’s recommendation that manufacturers provide safety data for half their clinical trial participants for a median of two months after they get their second vaccination shot. The FDA’s data request would make it exceedingly difficult, though not entirely impossible, for a vaccine to be cleared by Election Day, experts say.
The recommendation is a way of ruling out some vaccine-related side effects, such as spinal cord inflammation called transverse myelitis or blood clotting issues, several experts said.
When asked about the FDA’s new guidance, Trump said he thought the new standards sounded “like a political move” and warned the White House might reject them. “I don’t see why it should be delayed further,” Trump said. “That is a lot of lives you’re talking about.”