BNT162b2 vaccine is 95 percent effective against COVID-19, finds final efficacy analysis

The concluded Phase III study of BNT162b2 met all primary efficacy endpoints, with a consistent 95 percent efficacy across all patient populations.

Vial labelled 'COVID-19 CORONAVIRUS VACCINE' with syringe drawing from it

Pfizer and BioNTech’s COVID-19 vaccine candidate, BNT162b2, was 95 percent effective in preventing SARS-CoV-2 infection 28 days after the first dose, according to the final efficacy analysis. This efficacy was also consistent whether the participant had previously been infected with SARS-CoV-2 or not and across all age, race and ethnic groups.

The primary objective analysis looked at 170 confirmed cases of COVID-19, with 162 occurring in the placebo group and eight in the vaccine group. This equated to a 95 percent efficacy, which was also conserved in adults over 65 years of age.

According to the analysis, there were 10 cases of severe COVID-19 in the trial, one in the BNT162b2 vaccinated group and the other nine in the placebo group.

The independent Data Monitoring Committee has not reported any serious safety concerns relating to the vaccine, with most adverse events resolving shortly after vaccination. The only severe (Grade 3) events greater than or equal to two percent in frequency after the first or second dose were fatigue (under four percent) and headache (two percent). Interestingly, older adults tended to report fewer and milder adverse events following vaccination.

The companies also reported that this data means the vaccine has reached the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). They intend to submit a request for that EUA, including the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine, within the coming days to the FDA for an EUA based on the. These data also will be submitted to other regulatory agencies around the world.

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

The Phase III clinical trial of BNT162b2 has enrolled 43,661 participants to date, 41,135 of whom have received their second dose of the vaccine candidate as of 13 November 2020. Approximately 42 percent of global participants and 30 percent of US participants have racially and ethnically diverse backgrounds. Additionally, 41 percent of global and 45 percent of US participants are 56-85 years of age.

The enterprises state they expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.

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