COVID-19 Vaccine Authorized in the UK

The Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (U.K.) issued a temporary authorization for emergency use for the COVID-19 mRNA vaccine (BNT162b2) against COVID-19.

This announcement is the first Emergency Use Authorization (EUA) following a worldwide Phase 3 trial of a vaccine to help fight the pandemic, said Pfizer and BioNTech SE in a press release issued on December 2, 2020.

These companies anticipate further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.

“The EUA in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” stated Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized.”

“We aim 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,” added Dr. Sahin.

The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001) 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 first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol. 

The BNT162b2 vaccine efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. 

BNT162b2 was generally well-tolerated in the trial, with no serious safety concerns reported by the Data Monitoring Committee to date.

In July 2020, Pfizer and BioNTech announced an agreement with the U.K. to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. 

Now that the vaccine is authorized in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfillment expected in 2021.

The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. 

Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech can produce mRNA for commercial supply after producing the vaccine candidate doses for the clinical trials. 

BioNTech will also increase its manufacturing capacity in 2021, once the third site in Germany starts manufacturing to provide further capacities for a global supply of the potential vaccine. Critical to distribution in the U.K. will be Pfizer’s manufacturing site in Puurs, Belgium, one of Pfizer’s largest sterile injectable sites. 

The Puurs site is being used primarily for European supply and serves as a backup supply to Kalamazoo, Michigan, for the U.S. market.

Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to 6-months.

The companies have developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate to assure product quality, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods of time without any additional equipment but dry ice.

BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a Roche Group, Regeneron, and Genevant Fosun Pharma, and Pfizer. 

Also, the FDA has scheduled its review of the BNT162b2 vaccine for December 10, 2020.

FDA Commissioner Stephen M. Hahn, M.D., said in a press release issued on November 20, 2020: “The FDA understands there is tremendous public interest regarding vaccines for COVID-19.”

“We remain committed to keeping the public informed about the evaluation of the data of a potential COVID-19 vaccine, so that once available, the public and the medical community can have trust and confidence in receiving the vaccine for our families and ourselves,” concluded Dr. Hahn.

PrecisionVaccinations publishes research-based vaccine development news.