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Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.
Pfizer and BioNTech SE announced on Nov. 18, 2020 that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the Phase III study’s primary efficacy endpoints. In addition, the companies announced that the safety milestone required by FDA for Emergency Use Authorization (EUA) has been achieved. The companies plan to submit a request to FDA for an EUA based on the safety and efficacy data collected to date and manufacturing data relating to the quality and consistency of the vaccine, and data will also be submitted to other regulatory agencies around the world.
Pfizer’s interim data, announced Nov. 9, showed 90% efficacy, and the data announced Nov. 18 indicated a vaccine efficacy rate of 95% based on 170 cases of COVID-19. The press release said that 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, and observed efficacy in adults over 65 years of age was over 94%.
No serious safety concerns related to the vaccine have been reported. According to the press release, data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled. The trial will continue to collect efficacy and safety data in participants for two years.
“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, in the press release.
“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, MD, CEO and cofounder of BioNTech, in the press release. “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement. We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond.”
The companies reported that they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021. Pfizer’s facilities in St. Louis, MO; Andover, MA; and Kalamazoo, MI in the US and Puurs in Belgium are involved in the manufacturing and supply chain; BioNTech’s German sites will also be leveraged for global supply. The companies have designed a temperature-controlled thermal shipper using dry ice, which can be used be as a temporary storage unit for 15 days by refilling with dry ice. GPS-enabled thermal sensors on the shippers will track the location and temperature of each vaccine shipment through Pfizer’s distribution network.