To support evaluating a third or booster dose of the companies’ COVID-19 vaccine (BNT162b2) for future licensure Pfizer and BioNTech submitted Phase 1 data to the U.S. FDA.
Pfizer and BioNTech submitted Phase 1 data part of their Phase 1/2/3 clinical trial program – evaluating the safety, tolerability, and immunity of a third dose of the COVID-19 vaccine in U.S. adult participants from Phase 1 trial of the two-dose series.
Participants received a 30-µg booster dose of BNT162b2 8 to 9 months after acquiring the second dose. Results from this participant group show that the third dose evoked significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus (wild-type) compared to the levels observed after the two-dose primary series and against the Beta variant and the exceedingly contagious Delta variant.
Phase 3 results assessing the third dose are expected shortly and submitted to the FDA, the EMA and other regulatory authorities worldwide.
The third dose of the Pfizer-BioNTech vaccine is currently not authorized for general use in the U.S. However, under the current revised Emergency Use Authorization, a third dose was approved on August 12 for administration to individuals at least 12 years of age who have undergone solid organ transplantation or who are diagnosed with conditions that consider having an equivalent level of immunocompromise.
This authorization roots on information from an independent report evaluating the safety and effectiveness of a third dose in people who received solid organ transplants, the statement read.
A booster vaccine could help dwindle infection and disease rates in previously vaccinated people and better control the spread of virus variants during the coming season, mentioned Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
