Pfizer and BioNTech’s mRNA-based vaccine candidate BNT162b2 was found to be 95% effective against coronavirus disease 2019 (COVID-19) beginning 28 days after the first dose, according to a final analysis of phase 3 data.
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 phase 3 trial is investigating a 2-dose series in which the vaccine is administered intramuscularly 21 days apart. Among the 43,661 participants currently enrolled in the study, 41,135 have received a second dose. The analysis of the primary outcomes was based on 170 confirmed cases of COVID-19.
Results showed 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%.
As for safety, the vaccine was found to be well tolerated, with no serious adverse events reported. Fatigue and headache were noted to be the only grade 3 solicited adverse events greater than or equal to 2% in frequency.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, MD, CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class.”
According to Pfizer and BioNTech, submission for Emergency Use Authorization with the Food and Drug Administration is imminent. Manufacturing efforts are already increasing to keep up with potential demand; the Companies expect to produce up to 50 million doses by the end of 2020 and possibly more than 1.3 billion doses by the end of 2021. Additionally, temperature-controlled thermal shippers have been designed to distribute the vaccine, which needs to be stored at -70°C±10°C.
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.