A member of the committee tasked with advising the Food and Drug Administration on COVID-19 vaccine approval expressed worry to TPM about political meddling in the process of vaccine approval.
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital Philadelphia and a member of the FDA’s Vaccine and Related Biological Products Advisory Committee, said in an interview that he was concerned the FDA may not rely on the traditional expert committees used to evaluate vaccines for safety and efficiency. And he cited the case of hydroxychloroquine as a potential harbinger of what is to come.
“Who are they relying on to make this decision? Are they relying on [FDA commissioner] Stephen Hahn? A committee?” Offit asked. “The committee that makes these decisions is the vaccine advisory committee. They’re usually the one to make a recommendation.”
The New York Times reported on Sunday that scientists are concerned that the Trump administration may try to intervene to get a vaccine candidate rushed into deployment before the November elections.
Offit told the paper that “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.'”
TPM reported that the Trump administration plans to start its messaging campaign for the vaccine in the fall, with the aim of “overwhelming the airwaves” by November.
Offit said that he would be surprised if the currently ongoing vaccine trials yielded “meaningful data before early next year.” The trials, he explained, won’t be able to enroll enough participants in them to even begin in earnest until October.
So the question would then come down to whether the FDA would be willing to grant emergency use approval — known as an EUA — to a vaccine candidate before the election, with at best extremely limited data confirming effectiveness.
“As long as the FDA reviews these data on what is clearly a trial where there’s clear statistical significance that the vaccine works, then it doesn’t matter how it’s licensed,” Offit said. “If it’s licensed in a normal way, if it’s approved through the EUA, that’s okay, as long as the phase three data is there.”
He added that even the successful vaccine candidates would likely not protect against all forms of the disease.
Offit recalled to TPM the case of hydroxychloroquine — the drug that President Trump has continually touted as a cure for COVID-19, in the face of available evidence.
The FDA issued an emergency use authorization for the drug on April 27, under pressure from the Trump administration. The agency then rescinded that authorization in June, amid reports that the drug comes with severe side effects that could be fatal.
“It would be on the FDA to grant approval of one or more vaccines through the EUA,” Offit said. “This is what happened with hydroxychloroquine — it was approved for use, and there was no data to show that it worked. Not only did it not work to treat patients, but it had serious side effects.”