COVID-19 Vaccine Successfully Completes Phase 3 Study
Two international vaccine producers announced that after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
New York-based Pfizer Inc. and Germany based BioNTech SE announced on November 18, 2020, the analysis of the phase 3 data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection, which was the first primary objective.
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.
Additionally, this vaccine efficacy rate was also found in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7-days after the second dose.
There were 10 severe cases of COVID-19 observed in the trial, with (9) of the cases occurring in the placebo group and (1) in the BNT162b2 vaccinated group.
To date, the Data Monitoring Committee for the study has not reported 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 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2.
Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination.
In addition, the 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 plan to submit a request within days 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.
“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 power of BNT162 in providing early protection,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These achievements highlight the potential of mRNA as a new drug class.”
Based on current projections, the companies 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 stated they plan to submit the efficacy and safety data from the phase 3 study for peer-review in a scientific journal once the analysis of the data is completed.
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