First Authorization in the World for a COVID-19 Vaccine Issued in UK for Pfizer and BioNTech Vaccine

The coronavirus disease 2019 (COVID-19) mRNA vaccine, BNT162b2, developed by Pfizer and BioNTech, has been granted a temporary authorization for emergency use against COVID-19 by the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. This is the first Emergency Use Authorization (EUA) for a COVID-19 vaccine to be issued following an international phase 3 trial testing the safety and efficacy of the vaccine.

In the coming days and weeks, further regulatory decisions are expected to take place throughout the world for BNT162b2. Following potential regulatory authorizations or approvals in these countries, Pfizer and BioNTech explained in a press release that they are ready to deliver vaccine doses immediately.

In the United Kingdom, the distribution of the vaccine will be prioritized based on the guidance released by the Joint Committee on Vaccination and Immunisation.

“The Emergency Use Authorization in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “We believe that the roll-out of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”

The EUA for BNT162b2 in the United Kingdom was based on a rolling submission that included data from a phase 3 clinical study assessing the safety and efficacy of the vaccine. The study had demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which was the first primary objective, and also in participants with and without prior SARS-CoV-2 infection, which was the second. For both study objectives, the efficacy rate was measured from 7 days after the second dose of the vaccine.

For the first primary objective, the analysis was based on 170 cases of COVID-19. The observed efficacy in adults aged 65 years and over was more than 94%, with consistency in the efficacy rate across age, gender, race, and ethnicity demographics.

During the trial, BNT162b2 was found to be well tolerated by patients. Additionally, there have been no serious safety concerns reported to date by the Data Monitoring Committee.

Pfizer and BioNTech had established an agreement with the United Kingdom in July 2020 to supply the government with 30 million doses of BNT162b2 upon the issuance of an EUA in the country. Later in October, the agreed upon amount was increased to 40 million doses.

The distribution of the agreed upon 40 million doses will take place in stages during 2020 and throughout 2021. This distribution schedule is expected to ensure an equitable allocation of the vaccine across the countries with which Pfizer and BioNTech have made such agreements, according to a press release.

Due to the vaccine’s authorization in the United Kingdom, Pfizer and BioNTech will begin to deliver vaccine doses to the country immediately. The first doses are expected to arrive in the United Kingdom in the coming days, with delivery fulfilment completed during 2021.

Pfizer and BioNTech have filed a request for an EUA with the FDA and have also submitted the final authorization application with the European Medicines Agency, as well as several other regulatory agencies around the globe.

“Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said Albert Bourla, chairman and chief executive officer of Pfizer, in the press release. “As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”

REFERENCE

Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19. New York, NY: Pfizer and BioNTech; December 2, 2020. businesswire.com/news/home/20201201006304/en. Accessed December 2, 2020.