Days after reporting over 90 per cent efficacy, Pfizer and BioNTech on Wednesday announced that its COVID-19 vaccine candidate - BNT162b2 - has met all of the primary efficacy endpoints. Concluding from the analysis, the biotech firm stated that its vaccine candidate has shown an efficacy rate of 95 per cent in participants with and without prior COVID infection. However, the efficacy reduced by a per cent in adults over the age of 65 years. The analysis by Pfizer and BioNTech is based on 170 participants.
The companies have also announced that it has achieved the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). Based on the safety and efficacy data collected, the firms intend to submit a request within days to the FDA for a EUA. The announcement comes just two days after Moderna reported that its vaccine candidate had shown nearly 95% efficacy rate.
“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.
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42 per cent of global participants and 30 per cent of U.S. participants have racially and ethnically diverse backgrounds, and 41 per cent of global and 45 per cent of U.S. participants are 56-85 years of age.
Moderna on Monday reported that its COVID-19 vaccine candidate has proven to be 94.5 per cent effective. The biotechnology company has informed that it intends to submit the COVID-19 vaccine candidate for an Emergency Use Authorization (EUA) with the United States' Food & Drug Administration (FDA). The analysis released by Moderna which has reported 94.5 per cent efficacy of the COVID-19 vaccine was based on results of more than 30,000 participants in the US.