Pfizer to Seek Full Approval of Its COVID-19 Vaccine This Month

May 5, 2021

Pfizer said yesterday that it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic.

The FDA granted Emergency Use Authorization (EUA) for the vaccine, co-developed with BioNTech, on Dec. 11, 2020, for individuals 16 years of age and older, but the authorization is only good through the end of the public health emergency.

A Pfizer spokesperson confirmed yesterday that the company expects to submit a Biologics License Application (BLA) to the FDA this month seeking full approval for the vaccine. For a full approval, the agency will require six months’ worth of supporting data, compared with just 2 months for an EUA.

The FDA is expected to revise the Pfizer EUA by early next week to include teenagers ages 12 to 15. The drugmakers filed for an updated EUA after reporting that the vaccine showed 100 percent efficacy for this population in a phase 3 U.S. trial of 2,260 participants. The vaccine also induced strong antibody responses and was well-tolerated, the companies said (DID, April 1).

The FDA declined to comment on the timing of an amended EUA but said it is “working to review this request as quickly and transparently as possible.”

Pfizer is also preparing a booster shot aimed at combating variants of SARS‑CoV‑2, with an EUA for the new shot expected later this year. To support that submission, the two companies launched a study in February evaluating the safety and immunogenicity of a retooled third dose of their vaccine against new variants (DID, Feb. 26).

Pfizer is also planning to launch a new study assessing the co-administration of its COVID-19 vaccine with an influenza vaccine candidate, with results expected during this year’s third quarter. — Jason Scott