Trump Official Won’t Promise Outside Experts Will Vet Emergency Vaccine Approval
The New York Times reported on Sunday that scientists are concerned about political influence over the Trump administration’s coronavirus vaccine efforts as Operation Warp Speed seeks to deliver a vaccine by October.
- “Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation,” the newspaper reported, citing interview with administration officials, federal scientists and outside experts.
- The October deadline increasingly appears unattainable, according to the report, and “the administration [is] now pushing to have hundreds of millions of doses available by the end of the year or early 2021.”
- However, “experts inside and outside the government still say they fear the White House will push the Food and Drug Administration to overlook insufficient data and give at least limited emergency approval to a vaccine, perhaps for use by specific groups like front-line health care workers, before the vote on Nov. 3.”
“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, ‘We’ve tested it on a few thousand people, it looks safe, and now we are going to roll it out,’” said Dr. Paul A. Offit of the University of Pennsylvania, who is a member of the Food and Drug Administration’s vaccine advisory committee.
“They are really worried about that,” he added. “And they should be.”
- The Times noted that the president “relentlessly touts progress toward a vaccine, raising hopes of quick approval,” adding: “Touring a North Carolina biotechnology lab last week, he vowed to ‘deliver a vaccine in record time.’”
- The report also recalled that “In a tweet last month, he explicitly tied vaccines to his re-election hopes.”
- And Trump said during a campaign call with supporters in Pennsylvania on Sunday evening that the “F.D.A. has been great, at my instruction,” adding: “We expect to have a vaccine available very, very early before the end of the year, far ahead of schedule. We’re very close to having that finalized.”
The Times reported that the “threshold for approving vaccines is typically higher than it is for therapeutic drugs because they will be used in millions of otherwise healthy people, meaning that even rare side effects could affect many more people than a drug that treats a specific illness.”
An independent advisory panel of outside experts also weighs in, and while the agency has the power to make its own decision, it typically follows the advice of its outside panels. The Food and Drug Administration’s senior regulator has the power to approve or deny vaccines for emergency use, but that decision could be overridden by the agency’s top leaders, or by the secretary of health and human services.
Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, recently told The Journal of the American Medical Association in an online interview that it is his “job as commissioner is to make sure to the fullest extent possible that any pressure that comes to the agency is not reflected downward” onto regulators and scientists working on the vaccines.
However, according to The Times, “a senior administration official refused to promise that any emergency approval of a vaccine would be vetted through the Food and Drug Administration’s outside advisory panel of experts, scheduled to meet on Oct. 22.”
Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force, told lawmakers on Friday that he is “cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.”
Dr. Fauci has expressed confidence that the system will hold.
“Historically, the F.D.A. has based their decisions on science,” he told a House committee last week. “They will do so this time also, I am certain.”