Pfizer and BioNTech will submit an Emergency Use Authorization (EUA) request to the Food and Drug Administration (FDA) for their mRNA-based vaccine candidate BNT162b2 against coronavirus disease 2019 (COVID-19).
BNT162b2 is a nucleoside-modified messenger RNA (modRNA) vaccine that encodes an optimized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein antigen. The EUA submission is based on data from the phase 3 trial assessing a 2-dose series of BNT162b2 administered intramuscularly 21 days apart. The trial has currently enrolled 43,661 participants, of which 41,135 received a second dose. The analysis of the primary outcomes was based on 170 confirmed cases of COVID-19.
Results demonstrated that the vaccine was found to be 95% effective (P <.0001) in participants without prior SARS-CoV-2, as well as in those with or without evidence of infection before vaccination, based on the breakdown of cases in the BNT162b2 (n=8) and placebo arms (n=162). The data also included 10 severe cases, 9 of which occurred among participants in the placebo group.
Additionally, subgroup analysis revealed consistent efficacy across age, gender, race and ethnicity demographics. Among participants over 65 years of age, vaccine efficacy was observed to be over 94%.
The submission is also supported by solicited safety data from a randomized subset of approximately 8000 participants aged 18 years and older and unsolicited safety data from approximately 38,000 participants who have been followed for a median of 2 months after the second dose. Furthermore, solicited safety data on approximately 100 children aged 12-15 years old was included.
“[…] Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
Pfizer and BioNTech will be ready to distribute the vaccine candidate within hours after authorization.
1. Pfizer and BioNTech to submit emergency use authorization request today to the US FDA for COVID-19 vaccine. [press release]. New York, NY & Mainz, Germany; November 20, 2020.
2. Pfizer and BioNTech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. [press release]. New York, NY & Mainz, Germany; November 18, 2020.