Pfizer Inc and BioNTech SE stated that their mRNA-based vaccine candidate revealed that BNT162b2, their mRNA-based vaccine candidate against SARS-CoV-2 has shown proof of effectiveness against COVID-19 in members without previous indication of SARS-CoV-2 infection, based on the first interim effectiveness study conducted on 8th November 2020 by an external, autonomous Data Monitoring Committee (DMC) from the Phase 3 clinical study.

Following the discussion with the FDA, the organizations lately elected to drop the 32-case interim study and performed the 1st interim study at minimum 62 cases. After concluding the discussions, the evaluable case count stretched to 94 and DMC conducted its first analysis on all cases.

The case was divided between vaccinated individuals and those who got the placebo specifies a vaccine efficacy rate over 90%, at 7 days after the 2nd dose. This signifies that the protection can be achieved 28 days after the beginning of the vaccination, which includes a 2-dose schedule. With the continuation of the study, the concluding vaccine effectiveness percentage may vary. DMC has not reported any severe safety recommends and concerns that the analysis continue to accumulate extra efficacy and safety data as strategized. It is reported that the data will be discussed with governing authorities across the globe.

The Phase 3 clinical study of BNT162b2 started on 27th July and has registered 43,538 participants to date. Of those 38,955 got a second dose of the vaccine candidate on 8th November 2020. Around 30% of U.S. participants and 42% of worldwide participants have ethnically and racially diverse backgrounds. The study is continuing to register and is projected to continue through the final analysis when overall 164 confirmed COVID-19 cases have accrued.

The study also assesses the potential for the vaccine candidate to give protection against COVID-19 in ones who had earlier exposure to SARS-CoV-2 and vaccine prevention against the COVID-19 disease. Furthermore, along with initial efficacy endpoints assessing confirmed COVID-19 cases accruing from seven days after the 2nd dose, the last study will include the approval of the FDA and new secondary endpoints assessing effectiveness which are based on accruing 14 days after the second dose also.

Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against