Pfizer and BioNTech Announce Final Efficacy Analysis of Their mRNA-Based COVID-19 Vaccine Candidate BNT162b2 Reaching All Primary Endpoints

Pfizer and BioNTech SE announced on November 18 that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all primary efficacy endpoints in the ongoing Phase 3 study following a final efficacy analysis. Data analysis demonstrated a vaccine efficacy of 95% (p < 0.0001) among participants without prior SARS-CoV-2 infection (the first primary objective) and among participants with and without prior SARS-CoV-2 infection (the second primary objective), measured starting from 7 days after the second dose in each case. The initial primary endpoint analysis was based on 170 confirmed COVID-19 cases as specified in the study protocol, with 162 cases observed in the placebo group and 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race, and ethnicity demographics.

Ten severe COVID-19 cases were observed in the trial, with nine occurring in the placebo group and one in the BNT162b2 vaccination group.

To date, the Data Monitoring Committee for this study has not reported any serious safety concerns related to the vaccine. The final analysis, which included a review of unblinded reactogenicity data from a randomized subgroup of at least 8,000 participants aged 18 years and older in the Phase 2/3 trial, indicated that the vaccine was well tolerated, with most adverse events resolving shortly after vaccination. The only Grade 3 (severe) adverse events with an incidence rate greater than or equal to 2% after the first or second dose were fatigue (3.8%) and headache (2.0%) following the second dose. Consistent with earlier co-primary outcomes, older adults tended to report fewer and milder adverse events following vaccination.

Furthermore,The two companies announced that they had achieved the safety milestones required for Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).Pfizer and BioNTech plan to submit an Emergency Use Authorization (EUA) application to the FDA within days, based on the cumulative safety and efficacy data collected to date, along with manufacturing data related to vaccine quality and consistency. These data will also be submitted to other regulatory authorities worldwide.

“The results mark a significant step in this historic eight-month journey toward proposing a vaccine that can help end this devastating pandemic,” said Dr. Albert Bourla, Chairman and CEO of Pfizer. “We will continue to move at the speed of science to compile all data collected thus far and share it with regulatory authorities around the world. With thousands of people being infected globally every day, there is an urgent need to provide safe and effective vaccines to the world.”

“We are pleased that the first global trial to reach the final efficacy analysis milestone has demonstrated that a high level of protection against COVID-19 can be achieved very rapidly after the first 30 µg dose, highlighting the strong capability of BNT162 in providing early protection,” said Dr. Ugur Sahin, CEO and Co-Founder of BioNTech. “These achievements underscore the potential of mRNA as a new class of medicines. From the outset, our goal was to design and develop a vaccine that would induce rapid and effective protection against COVID-19 and be well tolerated across all age groups. We believe that, to date, we have achieved this objective with our candidate vaccine BNT162b2 in all studied age groups, and we look forward to sharing further details with regulatory authorities. I would like to thank all the dedicated men and women who have contributed to this unprecedented achievement. We will continue to collaborate with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”

The Phase 3 clinical trial of BNT162b2 commenced on July 27. To date, 43,661 participants have been enrolled, and as of November 13, 2020, 41,135 of them had received the second dose of the vaccine candidate. Approximately 42% of global participants and 30% of U.S. participants were from diverse racial and ethnic backgrounds. Globally, 41% of participants, and 45% of those in the United States, were aged 56–85 years. The diversity of clinical trial participants is reflected across approximately 150 trial sites in the United States, Germany, Turkey, South Africa, Brazil, and Argentina. The trial will continue to collect efficacy and safety data from participants for two years.

According to current predictions,The two companies expect to produce up to 50 million doses of the vaccine globally by 2020, and up to 1.3 billion doses by the end of 2021.Pfizer’s four facilities are part of the production and supply chain: St. Louis, Missouri; Andover, Massachusetts; Kalamazoo, Michigan, in the United States; and Puurs, Belgium. BioNTech’s facility in Germany will also be used for global supply.

Pfizer is confident in its extensive experience, expertise, and existing cold-chain infrastructure for global vaccine distribution. The two companies have developed specially designed thermal shipping containers that use dry ice to maintain temperatures at -70°C ± 10°C.By replenishing dry ice, they can serve as temporary storage units for 15 days. Each shipper includes a GPS-enabled thermal sensor to track the location and temperature of each vaccine batch along its scheduled route, leveraging Pfizer’s extensive distribution network.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study to scientific journals for peer review after completing the data analysis.

Responsible Editor: Sanqi

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