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.
Recently, the head of Pfizer announced that the company wouldn’t apply for emergency use authorization for its Covid-19 vaccine until at least mid-November. With all the talk about the potential to have a vaccine before Election Day, this sounds like bad news. What do you make of it?
Dr. Prescott Prescribes
Throughout the summer and fall, Pfizer’s experimental vaccine has established itself as the front runner to complete clinical trials and go before the FDA for emergency authorization. Still, I certainly wouldn’t interpret recent news as a negative development.
In light of increased pressure from the White House to have a vaccine by Election Day, coupled with rising safety concerns from the American public about a rushed approval process, the FDA in September issued additional guidance about vaccine trials. This new guidance recommended that all trials monitor participants for at least two months after their final vaccination.
As a result, Pfizer extended the time period it follows the health status of the tens of thousands of subjects enrolled in its vaccine trial. The additional monitoring stretches the length of the trial, but it increases the chances of detecting any potential side effects that could occur after vaccination.
At a moment when we’re losing thousands of American lives each week to the pandemic, a delay of even weeks can seem like an eternity. But the additional surveillance helps ensure any vaccine reaching the American public will be both safe and effective.
Chances still are strong Pfizer’s vaccine will receive the green light from the FDA before year-end. (And we might even see a second authorization for a vaccine from Moderna, a Pfizer competitor, before 2021.)
That would mean we’d gone from first identifying the novel coronavirus to a vaccine in only a year. The next fastest vaccine — for Ebola, approved by the FDA in December 2019 — took nearly six years.
Now, we’re poised to cut that standard by more than 80%. I wouldn’t call that bad news; I’d call it a mind-blowing advancement.