Pfizer and BioNTech Announce Submission of EUA Request to FDA for COVID-19 Vaccine BNT162b2 Following Successful Phase 3 Trial

On November 18, Pfizer and BioNTech announced that their mRNA-based candidate COVID-19 vaccine, BNT162b2, met all primary efficacy endpoints in the final efficacy analysis of its Phase 3 clinical trial. Data analysis indicated a vaccine efficacy of 95% (p<0.0001), measured starting 7 days after the second dose, in participants both without prior SARS-CoV-2 infection (first primary objective) and with or without prior SARS-CoV-2 infection (second primary objective). The analysis for the first primary objective was based on 170 confirmed COVID-19 cases as specified in the study protocol, including 162 cases in the placebo group and 8 cases in the vaccine group. Efficacy was consistent across demographic subgroups defined by age, sex, ethnicity, and race. Efficacy exceeding 94% was observed in adults aged 65 years and older.

Ten cases of severe COVID-19 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 vaccine-related safety concerns. A review of unblinded reactogenicity data from the final analysis—including a randomized subset of at least 8,000 participants aged 18 years and older in the Phase 2/3 clinical trials—indicated that the vaccine was well tolerated, with most adverse events resolving shortly after vaccination. Grade 3 adverse events occurring in ≥2% of participants after either the first or second dose were fatigue (3.8%) and headache (2.0%) following the second dose. Consistent with earlier shared results, older adults tended to report fewer and milder adverse events after vaccination.

Furthermore, Pfizer and BioNTech announced that the safety milestone required by the U.S. FDA for Emergency Use Authorization (EUA) has been achieved. They plan to submit an EUA application to the FDA within days, based on all safety and efficacy data collected to date, as well as manufacturing data related to vaccine quality and consistency. These data will also be submitted to other regulatory authorities worldwide.

“These results mark an important step forward in our historic eight-month journey to offer a vaccine that may help end this devastating pandemic. We continue to move at scientific speed, sharing all data collected to date with regulators around the world,” said Dr. Albert Bourla, Chairman and Chief Executive Officer of Pfizer. “With hundreds of thousands of people being infected every day around the world, we have an urgent need to provide a safe and effective vaccine to the world.”

“We are very pleased that the first global trial to reach its final efficacy analysis milestone demonstrates that a high level of protection against COVID-19 can be achieved very rapidly after the first dose of the 30 µg vaccine, highlighting the strength of BNT162b2 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. Our goal from the outset was to design and develop a vaccine that would provide rapid and robust protection against COVID-19 while being well tolerated across all age groups. We believe our candidate vaccine, BNT162b2, has achieved this in all age groups studied to date, and we look forward to sharing further details with regulatory authorities.”

References:

[1] Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints. Retrieved 2020-11-18, from https://www.businesswire.com/news/home/20201118005595/en

Source: Jike Pharmaceutical News

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