FDA approves Pfizer's COVID-19 shot: What is licensure?

The Pfizer-BioNTech vaccine will now be marketed as Comirnaty 

Federal regulators issued full approval to the Pfizer-BioNTech COVID-19 vaccine on Monday, now marketed as Comirnaty, following rigorous review and independent analyses of data submitted through the companies' biologics license application. 

But what is licensure? And how could it help resolve the health crisis?

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COVID-19 vaccines developed by Pfizer, Moderna and Johnson & Johnson have all previously been granted emergency use authorization (EUA) after meeting the FDA's safety and efficacy requirements. Licensure is the next step beyond emergency authorization; EUAs are meant to address serious, threatening diseases where there are no other alternatives.

In a call with reporters Monday, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, detailed the FDA's review of Pfizer's biologics license application. The FDA completed the review in just over three months, or some 40% faster than usual, Marks said.

"This is a pivotal moment for our country in the fight against the pandemic," Dr. Janet Woodcock, acting FDA commissioner, said over the call, later adding, "We know that vaccine approval holds the promise of altering the course of the pandemic in the United States, and that for some, an FDA-approved COVID vaccine may instill in them the confidence to go and get vaccinated."

During the review process, the FDA evaluated updated clinical trial data among 40,000 participants aged 16 years and older, half of whom received a placebo. Trial results indicated the vaccine was 91% effective in preventing COVID-19 disease, though data will continue to be monitored as real-world evidence suggests waning immunity over time. 

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The FDA also evaluated vaccine safety among 44,000 trial participants aged 16 and older, with available follow-up safety data extending at least four months post-second dose for over half of trial participants. The most common side effects among participants included pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever. Of note, the FDA said data demonstrated an increased risk of myocarditis, or heart inflammation, among males under 40, with males aged 12-17 facing the highest observed risk. However, available data suggest most patients' symptoms have resolved, Marks said. Those risks are reflected in the vaccine prescribing information posted to the FDA website.

While the FDA's timeline for the approval process prompted criticism, with some arguing it took too long, Marks said the FDA evaluated data down to the individual patient level, and also ran inspections at clinical trial sites to ensure accuracy behind data collection, as well as inspections at facilities manufacturing the vaccine to ensure quality standards were met.

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"Doing those inspections in the middle of a pandemic were not trivial," Marks told reporters over a call.

The FDA reviewed adverse events, conducted its own analyses and completed benefit-risk assessments based on real-world rollout of the vaccine. According to federal estimates, over 204 million Pfizer-BioNTech COVID-19 doses have been administered.