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BioNTech and Pfizer Complete Phase 3 Study of COVID-19 Vaccine Candidate

Results published from the Phase 3 clinical trial showed the vaccine candidate, BNT162b2 to be 95 percent effective against COVID-19 beginning 28 days after the first dose, with all primary efficacy endpoints met.

After concluding their final efficacy analysis, BioNTech and Pfizer announced that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. The data also reveal a vaccine efficacy rate of 95 percent in participants without prior SARS-CoV-2 infection as well as participants with and without prior SARS-CoV-2 infection.

Each participant was measured from 28 days after the first dose, and 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 percent.

Within the trial, there were 10 severe cases of COVID-19, with nine of which occurring in the placebo group and the other in the group vaccinated with BNT162b2. At the point of the media release in November 2020, the Data Monitoring Committee for the study did not report any serious safety concerns related to the vaccine.

A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the Phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination. The only Grade 3 (severe) solicited adverse events greater than or equal to two percent in frequency after the first or second dose were fatigue at 3.8 percent and headache at two percent following the second dose. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.

“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 CEO.

“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.” He added.

“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 30 μg dose, underscoring the potential of BNT162 to provide early protection,” said Professor Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

Professor Ugur further noted that the results of this Phase 3 clinical trial, “highlight the potential of mRNA as a new drug class.”

In addition, the two companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech also submitted to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. These data also will be submitted to other regulatory agencies around the world.

The Phase 3 clinical trial of BNT162b2 began on 27 July 2020 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of 13 November 2020. Approximately 42 percent of global participants and 30 percent of U.S. participants have racially and ethnically diverse backgrounds, and 41 percent of global and 45 percent of U.S. participants are 56 to 85 years of age. The trial will continue to collect efficacy and safety data in participants for an additional two years.

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. [APBN]