Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster

Pfizer and BioNTech announced that they have submitted Phase I data to the US Food and Drug Administration (FDA) to support the evaluation of a third, or booster, dose of their COVID-19 vaccine BNT162b2 (now Comirnaty^®) for future licensure. The data will also be submitted to the European Medicines Agency (EMA) and other regulatory authorities in the coming weeks.

“We continuously strive to stay at least one step ahead of the virus,” said Ugur Sahin, Chief Executive Officer and co-founder of BioNTech. “This initial data indicate that we may preserve and even exceed the high levels of protection against the wild-type virus and relevant variants using a third dose of our vaccine. A booster vaccine could help reduce infection and disease rates in people who have previously been vaccinated and better control the spread of virus variants during the coming season.”

The BNT162b2 COVID-19 vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. The Phase I data evaluated the safety, tolerability, and immunogenicity of a third dose of the vaccine in US adult participants from the Phase I trial of the two-dose series. Participants received a 30µg booster dose of BNT162b2 eight to nine months after receiving the second dose.

Results from this participant group showed that the third dose elicited significantly higher neutralising antibodies against the initial SARS-CoV-2 virus compared to the levels observed after the two-dose primary series, as well as against the Beta variant and the Delta variant. After the booster dose, neutralising titers for variants were similar to wild-type. According to BioNTech, given the high levels of immune responses observed, a booster dose given within six to 12 months after the primary vaccination schedule may help maintain a high level of protection against COVID-19.

BioNTech stated that Phase III results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the US, Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application (BLA) in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021.

A third dose of the Pfizer-BioNTech vaccine is not currently authorised for broad use in the US; however, under the current amended Emergency Use Authorisation (EUA), a third dose was authorised on 12 August 2021 for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.