Waiting for full federal approval of Pfizer’s COVID-19 vaccine is no reason to delay protection, the director of the National Institutes of Health said Monday, but those still holding out for the end of the emergency authorization period might have only weeks to go.
The Food and Drug Administration could grant full approval of the Pfizer BioNTech vaccine “by the end of the summer,” Francis Collins, M.D., Ph.D, told the Washington Post.
“FDA is working 24/7 on this,” Collins said, noting the agency committed to finishing its review by January 2022. “Most of us expect they’ll get there sooner than that, maybe even by the end of summer.”
The end of the emergency use authorization, or EUA, could lead to an increase in staff vaccination rates at U.S. nursing homes, with many employees who have refused shots until now arguing that they don’t want them before the federal government reviews more data.
In a June survey conducted by the Kaiser Family Foundation, 31% of unvaccinated adults said they would be more likely to get a vaccine if it had received full approval by the FDA, with that share rising to nearly half among those in a “wait and see” group.
Many healthcare provider organizations also have avoided mandates, or delayed them, until the FDA grants its full approval.
Some critics have likened receipt of an EUA-only approved vaccination to taking experimental drugs, and Collins acknowledged shaking off the EUA designation should help move the needle on vaccinations across the nation.
But he added that much of the work the FDA is doing now is to review Pfzer’s manufacturing processes, noting that safety and efficacy evidence for its vaccine is “already overwhelming.” As of July 18, about 187.6 million doses had been administered in the U.S., making it by far the most popular option among three approved for emergency use during the public health crisis.
“Everybody should understand: There is really not any significant doubt among any of us who have seen the data that this is going to happen,” he added during the live event. “If anyone’s holding back now because they’re waiting for that full approval, I would say that’s not really a good reason to wait. Delta is spreading. People are at risk. People are dying.”
Pfizer and its European partner, BioNTech, began seeking full FDA approval for its two-dose vaccine in May, with clinical trial data showing the mRNA vaccine was about 95% effective against severe COVID-19 in recipients 16 and older. The companies announced Friday that the Food and Drug Administration would streamline its review by using a priority review process to handle the company’s application for full approval.
In its own statement, the FDA said it “intends to complete the review far in advance of the (licensure) goal date.”
Moderna on June 1 also applied to the FDA for full approval for its coronavirus vaccine, which is currently under emergency authorization for patients 18 and older.
