FDA approves Comirnaty as first COVID vaccine

Regulatory NewsRegulatory News | 23 August 2021 |  By 

The US Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s mRNA COVID-19 vaccine, Comirnaty, for people 16 years or older.
The announcement represents not just the first approved COVID-19 vaccine in the US, but also the first-ever approval for an mRNA therapy.
“This is a pivotal moment for our country in the fight against the pandemic,” FDA Acting Commissioner Janet Woodcock, MD, said during a media briefing on the vaccine’s approval. “While this and other vaccines have met the FDA's rigorous scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be confident that this vaccine meets the FDA's gold standards for safety, effectiveness and manufacturing quality that we require for an approved product.”
The approval was based on updated data from the clinical trial that led to FDA issuing an emergency use authorization (EUA) for the vaccine in December 2020. Safety was evaluated in a Phase 2 dose-escalation study (BNT162-01) of 60 participants in Germany who had not previously been exposed to SARS-CoV-2, while safety and efficacy data were derived from an international Phase 1/2/3 randomized, placebo-controlled trial (C4591001) of 44,047 participants. In the second study, Comirnaty’s efficacy was 91.1% at 7 days after the second dose in a comparison of 19,993 participants who received the vaccine and 20,118 participants who received placebo.
Comirnaty’s Biologics License Application (BLA) was approved in just 97 days, about 40% of the time it normally takes the agency to approve a product through the BLA process “for a submission of this magnitude,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research (CBER), said during the media briefing.
“This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done, but we want to underscore that our efforts to move as quickly as possible have in no way sacrificed scientific standards or the integrity of our process,” Woodcock said. “Approving the vaccine as rapidly as possible, while ensuring a rigorous and thorough review, has been our top priority.”
As part of the BLA process, FDA inspectors visited a percentage of clinical sites and manufacturing facilities; examined each patient in the trials for adverse events; and conducted their own independent analyses to determine whether the data matched what was submitted to the agency, Marks noted. The agency also conducted a benefit-risk assessment “based on real world-data that has emerged since the vaccine is now being used in hundreds of millions of people globally.”
“The FDA’s valuation of this biologics license application was incredibly thorough, and the public can trust that the data evaluated by the FDA on the vaccine’s safety, effectiveness and quality meet the agency's rigorous, globally recognized standards,” Marks said during the media briefing.
No changes were made to the formulation of the approved Comirnaty vaccine, and healthcare providers can continue to use stock of Comirnaty obtained while the vaccine was under emergency use authorization interchangeably with the approved formulation.
Marks noted FDA did find an increased risk of myocarditis and pericarditis in the 7 days after the second dose, with men under 40 years old and particularly adolescent boys 12-17 years old having an increased risk. “[A]vailable data from short-term follow-up suggests that most individual symptoms have now resolved after the occurrence of myocarditis,” he said.
Safety concerns for the vaccine will be monitored, and FDA has asked that Pfizer and BioNTech conduct postmarketing studies on the risks for myocarditis and pericarditis after receiving Comirnaty.
The companies also have indicated they will create a registry to monitor pregnancy and infant outcomes after pregnant individuals receive the vaccine.
Officials from Pfizer and BioNTech said they hoped the approval of Comirnaty would help reassure those who are hesitant to get the vaccine.  “Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60% of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” Albert Bourla, Chairman and Chief Executive Officer at Pfizer, said in a statement. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.”
The companies now are permitted by law to advertise Comirnaty to the public, if they follow FDA’s advertising, promotion and labeling requirements and ensure that promotional claims are in line with the approved label. Full approval also allows them to continue selling the vaccine when the current public health emergency ends.
Next steps
Comirnaty remains available to adolescents 12-15 years old under an EUA and a third dose has been authorized for some individuals with compromised immune systems due to solid organ transplantation or “an equivalent level of immunocompromise.”
In their media briefing, FDA shared no new information on extending Comirnaty’s EUA to other age groups, noting that trials are ongoing for evaluating the vaccine in children under 12 years of age. “We will obviously move swiftly once those data are submitted. But first, the trials have to be finished – or at least the parts of the trials that are going to be submitted to us have to be finished up – and then the data needs to be submitted to us,” Marks said.
The agency did not provide any new information on a timeline for authorizing a booster dose for the general population; however, full approval permits licensed healthcare providers to prescribe Comirnaty off-label, potentially as a booster dose.
On 20 August, the Centers for Disease Control and Prevention (CDC) announced it would back a COVID-19 booster shot in the fall starting 8 months after individuals received the second dose of either the Pfizer or Moderna COVID-19 mRNA vaccines, and pending an FDA authorization of booster doses. Pfizer and BioNTech recently submitted initial Phase 1 data to the agency on the effects of a booster dose approximately 8-9 months after participants received a two-dose series, while Moderna acknowledged the CDC’s announcement in a press release.
“A decision will be made about that in an appropriate time once we have these submissions in-house and we have been able to review them,” Marks said in the briefing.
Comirnaty Approval Letter
Comirnaty Package Insert


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