Pfizer and BioNTech Ask FDA For Full Approval of Their COVID Vaccine

Learn what this means and how soon the vaccine could be approved.

Pfizer and BioNTech Ask FDA For Full Approval of Their COVID Vaccine

Updated on May 7, 2021 at 8:00am EDT.

Pfizer and BioNTech have begun the process of seeking full approval from the U.S. Food and Drug Administration (FDA) for their COVID-19 vaccine for use in people age 16-years and older.

The mRNA vaccine was granted Emergency Use Authorization (EUA) in December 2020. Since then, roughly 170 million doses have been distributed across the United States and, as of May 6, more than 134 million doses have been received by Americans. It’s now the first vaccine that will be considered for full U.S. approval.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” said Albert Bourla, Pfizer chairman and CEO, in a May 7 news release. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

The difference between EUA and FDA approval?
An EUA from the FDA allows people to gain access to vital new drugs or vaccines during a public health crisis. This process is how all three coronavirus vaccines currently available in the United States received the greenlight for distribution across the country.

Under an EUA, the FDA may allow the use of unapproved treatments to help manage such a threat if certain safety criteria have been met and there are no other approved alternatives. An EUA, however, is only in effect for as long as the public health emergency lasts and can be revoked at any time.

When the FDA approves a drug, the agency has decided that it is effective, and its benefits outweigh its risks. This approval will remain in place even after the public health threat is gone. Once approved, the FDA must request removal if there are any issues concerning a drug’s safety or effectiveness.

Pfizer and BioNTech must demonstrate that their manufacturing processes and facilities ensure that they can produce their vaccine with quality and consistency. If approved, the companies would be allowed to market their vaccine in the U.S. directly to consumers.  

Safety monitoring will be ongoing
The FDA's traditional approval process can take years, but Pfizer says it has requested approval based on a “rolling submission,” speeding up the review process by allowing the FDA to review new data as it becomes available.

Data to support Pfizer and BioNTech’s Biologics License Application (BLA) will be submitted to the FDA over the coming weeks.

The companies have also asked for Priority Review, which means the FDA’s goal would be to take action on the application within 6 months—not 10 months under standard review. Keep in mind, this designation does not change the length of clinical trials, the scientific/medical standards or quality of evidence required for approval.

Once the submission is complete and the BLA is formally accepted for review by the FDA, the Prescription Drug User Fee Act (PDUFA) goal date for a decision will be determined.

“Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, MD, CEO and co-founder of BioNTech in a May 7 news release. “We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

Even if the vaccine is approved by the FDA, monitoring for safety and effectiveness doesn’t stop there. The FDA explains that surveillance will continue to identify any possible rare or long-term complications. So far, the vast majority of reported side effects have been mild. In some cases, the FDA could require additional Phase 4 trials to assess known or possible risks.

Vaccines are also closely monitored using various surveillance systems, such as the Vaccine Adverse Event Reporting System (VAERS), the FDA BEST (Biologics Effectiveness and Safety) program and the Centers for Disease Control and Prevention’s (CDC) Vaccine Safety Datalink.

Medically reviewed in May 2021.

Sources:
Pfizer. “PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR U.S. FDA APPROVAL OF THEIR COVID-19 VACCINE.” May 7, 2021.
Centers for Disease Control and Prevention. “COVID Data Tracker.” May 6, 2021.
U.S. Food and Drug Administration. “Emergency Use Authorization for Vaccines Explained.” Nov 20, 2020.
U.S. Food and Drug Administration. “Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19.” Dec 22, 2020.
Regulatory Affairs Professional Society. “Why FDA’s Issuance of EUAs are not ‘approvals’ and why that matters.” Apr 3, 2020.
U.S. Food and Drug Administration. “Priority Review.” Jan 4, 2018.
U.S. Food and Drug Administration. “Prescription Drug User Fee Amendments.” May 3, 2021.
U.S. Food and Drug Administration. “Vaccine Development – 101.” Dec 14, 2020.

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