Pfizer and BioNTech announced on 2 December 2020 that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency use for their Covid-19 mRNA vaccine (BNT162b2) against Covid-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech 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 vaccine distribution in the UK will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
“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, Pfizer. “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.”
“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, chief executive officer 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. 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 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. Efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. In the trial, BNT162b2 was generally well tolerated, with no serious safety concerns reported by the Data Monitoring Committee to date. Today’s decision is also based on reviewing Pfizer’s and BioNTech’s Chemistry, Manufacturing, and Control (CMC) data for BNT162b2.
In July 2020, Pfizer and BioNTech announced an agreement with the UK 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 UK, the companies will take immediate action to begin delivering vaccine doses. The first doses are expected to arrive in the UK in the coming days, with complete delivery fulfillment expected in 2021.
The companies have filed a request for Emergency Use Authorization with the US Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.
Manufacturing and delivery capabilities
Pfizer and BioNTech continue to collaborate with governments and Ministries of Health around the world that will distribute the vaccine, subject to country authorization or approval, to help ensure it can reach those most in need as quickly as possible. The companies are leveraging leading vaccine manufacturing and distribution capabilities to scale, manufacture quickly, and distribute large quantities of the vaccine at high quality, complementing the mRNA manufacturing expertise of BioNTech gained over almost a decade. Pfizer has a 171-year track record of researching, developing, manufacturing, and delivering innovative medicines and vaccines to patients in need. Pfizer and BioNTech are confident in their ability to safely and effectively deliver the vaccine to the people in the U.K. Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization).
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 UK 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 US 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 six months. The company’s distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need. So, this will minimize the need for long term storage anywhere. Vaccination in a pandemic situation is expected to be rapid, with high demand, and we do not expect that the product will need to be stored at any location for more than 30 days.
To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods without any additional equipment but dry ice. The shipper can maintain temperature for ten days unopened, which allows for transportation to markets globally. Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions (-70°C ±10°C) up to 30 days with re-icing every five days following the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track each vaccine shipment’s location and temperature 24 hours a day, seven days a week. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions.
From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the US and Europe, Latin America, and South Africa, reaching approximately 44,000 participants. Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization. BioNTech will hold the UK’s regulatory authorization and, if granted, in the US, the EU, Canada, and other countries. Pfizer will have the commercialization right worldwide except China, Germany, and Turkey.