The White House may have bullied the US Food and Drug Administration into giving emergency use authorization to using blood plasma from coronavirus survivors as a treatment for new patients, a prominent vaccine expert said Sunday.
I think what’s happening here is you're seeing bullying, at least at the highest level of the FDA, and I'm sure that there are people at the FDA right now who are the workers there that are as upset about this as I am," said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
Moving things along quickly is fine, Offit told CNN's Wolf Blitzer, but it's the FDA's job to hold products to a standard of safety and efficacy. Offit said he worries that the FDA, like other science-based agencies "get bullied to do what Donald Trump wants them to do, and I think it's a dangerous game he plays."
The potential side effects of convalescent plasma are not known, Offit said. While he said he thinks it is likely that it is generally a safe product, "until something has been shown clearly to work, we shouldn't put it out there."
It makes sense that administering a serum with high levels of neutralizing antibodies to a person who is mildly ill would help, but "the trick is proving that it makes a difference," Offit said minutes after the White House announcement about the EUA.
The data so far have not proved that the plasma makes a difference, said Offit, which is why the FDA was "loath" to approve the treatment.
In making the announcement, the FDA and Health and Human Services Secretary Alex Azar cited data from a study posted online to a pre-print server, meaning it had not been peer-reviewed, on August 12. Offit questioned whether there was newer data that the FDA had not shared.
By not presenting those new data, you wonder whether there really are any new data, and if there aren't then what just happened is that the administration just bullied the FDA into approving something that they were uncomfortable about approving," Offit said.
Offit said that what worries him the most is the repercussions this could have on vaccines.
You get the sense that if the same thing happens there, that we're willing to release a vaccine before there is clear evidence of safety or clear evidence of efficacy, that the American public, which is already skittish about vaccines … will only further lose confidence," he said.