The FDA’s full approval of Pfizer’s COVID vaccine may encourage more people to get it — and more companies to require it.
Pfizer, Moderna, and Johnson and Johnson’s vaccines have all been operating under emergency authorization. It’s estimated anywhere from 5% to 30% of unvaccinated people have been waiting for the vaccine to receive permanent approval. Governor Holcomb and Indiana health commissioner Kristina Box have said they believe that’s held back many of the nearly three-million unvaccinated eligible Hoosiers.
Holcomb has argued for weeks that with both serious COVID cases and serious side effects rare after millions of vaccinations, full approval is overdue. Former FDA Commissioner Mark McClellan says with many people viewing the FDA’s seal of approval as the “gold standard,” it was critical that the agency avoid anything in the review process which could later be viewed as cutting corners.
McClellan says the FDA still managed to grant approval within three months of Pfizer submitting its application, much faster than the more typical eight months.
McClellan says there’s been an incorrect perception that “emergency authorization” means the vaccine is “experimental.” He says for people who had safety concerns about the vaccine, the comprehensive FDA review should put those fears to rest. But he says doctors shouldn’t try to use it as a discussion-ender, but ask skeptical patients what their issues are.
McClellan, who headed the FDA for two years under President George W. Bush, now heads Duke University’s Margolis Center for Health Policy. He says the center worked with concert promoter Live Nation in crafting its announcement earlier this month it’ll require all ticket holders to be vaccinated. Within hours of the FDA announcement, New Jersey and New York City declared they’ll require all teachers and school staff to be vaccinated, while the Pentagon confirmed it’s preparing a vaccination order for all active-duty military.
McClellan says even under the emergency authorization, employers had wide authority to require vaccination. But he predicts full approval will give businesses and universities more confidence they’re on solid legal ground, and bring more acceptance from workers of those requirements.
An Indiana law passed in April prohibits the state or local governments from imposing a vaccine requirement. But that law doesn’t apply to private businesses, and Indiana University won a legal fight over its decision to require the vaccine for students and faculty.
McClellan says he expects the Moderna vaccine to receive permanent approval this fall, followed by the Johnson and Johnson vaccine, mirroring the order in which they received their emergency authorizations. McClellan serves on Johnson and Johnson’s board.
Pfizer is awaiting full approval for its vaccine for kids ages 12 to 15. The emergency authorization remains in effect for that age group. Clinical trials are still being conducted on kids younger that. McClellan says there have been no reports so far of serious side effects.
