Pfizer and BioNTech Jockeying for Approval of Booster Vaccine in Wider Population

Pfizer and BioNTech have submitted data to the FDA for approval of a third — or booster — dose of the their COVID-19 vaccine in healthy adults.

The data came from a phase 1 trial in which participants received a booster dose of the vaccine eight to nine months after getting the second dose. The companies announced yesterday that the third dose resulted in much higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild type) compared to the levels seen after the two-dose primary series, as well as against the Beta variant and the highly contagious Delta variant, which now accounts for most COVID-19 infections in the U.S.

“The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule,” said Pfizer CEO Albert Bourla.

Pfizer and BioNTech said they also plan to submit the data to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks. Meantime, phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities, the companies said.

In the U.S., Pfizer and BioNTech say they plan to seek approval for the third dose via a supplemental biologics license application (BLA) in people 16 years of age and older, pending FDA approval of the primary BLA submitted in May.

Under the current amended FDA Emergency Use Authorization, a third dose was approved on Aug. 12 for people at least 12 years of age who have undergone solid organ transplantation or who are diagnosed with other conditions that cause their immune systems to be weak. — Suz Redfearn