Each week, OMRF President Dr. Stephen Prescott opens “Adam’s Journal” to answer a medical question from OMRF Senior Vice President and General Counsel Adam Cohen.
This past week, I read that the FDA had changed its standards for okaying coronavirus vaccines and that this had generated political controversy. What happened, and why does it matter?
Dr. Prescott Prescribes
With President Trump repeatedly saying a Covid-19 vaccine will be available by Election Day, many have voiced concerns about the politicization of the vaccine approval process. In particular, significant numbers of Americans have worried that those vaccines may not be safe, and recent polls reflect this anxiety: Only 52% of Americans – and 47% of Oklahomans – say they’d get vaccinated.
The Food and Drug Administration will review vaccine candidates through an emergency use authorization process, which is far quicker than the formal approval that’s used for most drugs and vaccines. To ensure that this accelerated timeline doesn’t compromise vaccine safety or performance, the FDA just released new guidelines, which are more specific than earlier guidance it had provided.
Those new guidelines recommend that manufacturers provide safety data for an average of two months after trial participants receive their last shot of experimental vaccine. (Most of the vaccine candidates require two shots.) This timeline would make it extremely difficult for any vaccine to receive a thumbs up before Election Day.
The new guidance represents an attempt to rule out hidden side effects, like the report of a spinal cord inflammation that recently paused the trials of AstraZeneca’s experimental vaccine. At a vaccine forum this past week, the FDA’s top official overseeing vaccine reviews said, while rare, those type of side effects tend to occur 42 to 60 days after the second dose of a vaccination.
The White House has criticized the new guidance and demanded justification from the FDA. Whether this pressure results in any changes remains to be seen. However, I suspect it will not, as any relaxation of the standards would further undermine Americans’ confidence in the process.
The new standards mean that we may have to wait a bit longer for a vaccine. But that slight delay will be well worth it. Because getting Americans as safely and effectively vaccinated as possible is the way we will bring this pandemic to an end.