Pfizer and BioNTech celebrate historic first authorisation in US of vaccine to prevent Covid-19

The vaccine is now authorized under an Emergency Use Authorization (EUA) while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.

Under Operation Warp Speed, the Department of Defense (DoD) in partnership with agencies within the Department of Health and Human Services (HHS), including the U.S. Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.

“Pfizer’s purpose is breakthroughs that change patients’ lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”

“We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Today we are another step closer to our vision. We believe that today’s Emergency Use Authorization, and the subsequent distribution of our vaccine that has demonstrated an efficacy rate of 95% and a favorable safety profile, will help to save lives across the United States and could accelerate a return to normality.”

The FDA based its decision on the totality of scientific evidence shared by the companies, including data from a pivotal Phase 3 clinical study announced last month and published this week in The New England Journal of Medicine.

The Phase 3 data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. Efficacy was consistent across age, gender, race and ethnicity demographics. All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose.

Pfizer and BioNTech appreciate the continued participation of the approximately 44,000 trial volunteers and remain committed to the companies’ pledge to always make their safety and well-being the companies’ top priority. The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic. Pfizer and BioNTech plan to provide an option for trial participants who received the placebo to receive the vaccine at scheduled timepoints in the study. This vaccine transition option will be voluntary and will be implemented in alignment with the regulatory authorities where the trial is conducted.

In July 2020, Pfizer and BioNTech announced an agreement with the HHS and the DoD to meet the U.S. government’s Operation Warp Speed program goal to deliver doses of a vaccine for COVID-19. With the vaccine being authorized for emergency use in the U.S., the companies will begin delivering the first doses in the U.S. immediately, with delivery fulfillment expected to be completed in 2021.

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. A breakdown of the diversity of clinical trial participants can be found here from more than 150 clinical trial sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina.

The Phase 3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints are prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 17 years of age will be gathered in the months ahead. Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

Source: Company Press Release