Pfizer/BioNTech File for Full COVID-19 Vaccine Approval

First to receive Emergency Use Authorization (EUA) for their highly effective COVID-19 vaccine, Pfizer and BioNTech have now become first to submit a biologics license application (BLA) with the FDA for full approval of their inoculation.

Moderna is likely to be next to file for full FDA approval of its mRNA vaccine and the company has said it plans to begin a rolling BLA submission to the agency this month.

Full approval of vaccines is a significant milestone, allowing them to be marketed directly to consumers and to stay on the market after the pandemic.

The Pfizer/BioNTech BLA filing, which was submitted Friday, means that they now have the six-month follow-up data required to get their vaccine fully approved. The data, which will provide assurance that the two-dose mRNA vaccine is effective for at least six months, will be submitted to the agency over several weeks, the companies said.

Pfizer and BioNTech have so far submitted the clinical and nonclinical data the agency needs to see, including the most recent analyses from their phase 3 clinical trial. They demonstrated 91.3 percent efficacy against COVID-19, 100 percent efficacy in preventing severe disease as defined by the Centers for Disease Control and Prevention and 95.3 effectiveness in preventing severe disease as defined by the FDA.

Notably, the analyses also found that the vaccine fully shielded patients in South Africa against the concerning viral variant first identified in that country.

Additional manufacturing and facility data needed for the BLA submission will be submitted “in the coming weeks,” the companies said.

Johnson & Johnson, the only other drugmaker that has received an EUA for a COVID-19 vaccine, may have to wait a while longer before it’s ready to submit a BLA. The company, which has experienced serious setbacks regarding its vaccine, has not given a specific timeline, only announcing at the time of authorization that it planned to file “later in 2021.”

The FDA granted the J&J vaccine an EUA at the end of February, while Pfizer/BioNTech and Moderna received their authorizations in December 2020. It’s uncertain how much use the J&J vaccine will see in the U.S. vaccination program, given its production delays and its association with very rare blood clots.

In other developments on the Pfizer/BioNTech vaccine, the EU is reportedly close to finalizing a new 1.8 billion-dose supply deal — part of the trade bloc’s new focus on using mRNA-based vaccines.

In addition, a Centers for Disease Control and Prevention advisory panel will meet Wednesday to discuss authorizing the Pfizer/BioNTech vaccine for use in adolescent patients aged 12 to 15, according to a draft agenda for the advisory committee meeting. At the end of March, Pfizer announced that the vaccine demonstrated 100 percent efficacy and induced strong antibody responses in its phase 3 trial of 2,260 adolescent patients (DID, April 1). — James Miessler