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Today, Pfizer and BioNTech have announced that their mRNA vaccine (BNT162b2) against COVID-19 has been granted temporary authorization for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA) in the UK.
This constitutes the first emergency use authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech say they are anticipating further regulatory decisions across the globe, and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.
“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,” 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.”
Vaccine efficacy and safety data
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% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose.
The data is based on 170 cases of COVID-19, as specified in the study protocol, and exceeds the companies’ earlier reported efficacy of 90%. Efficacy was reported to be consistent across age, gender, race and ethnicity demographics, and notably displays an efficacy of over 94% in adults age 65 and older, a major at-risk population.
In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported to date.
Manufacturing and delivery capabilities
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 companies say that delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines where they’re needed. The first doses are expected to arrive in the coming days, with complete delivery fulfillment expected in 2021.
Speaking to the Guardian, the UK’s health secretary, Matt Hancock, said the first doses would first be issued to the most vulnerable populations, which includes the elderly and those in care homes, including staff. Hancock also said that NHS staff were a high priority as well as clinically vulnerable people.
Shipping a frozen vaccine
Pfizer and BioNTech’s vaccine is one of many being developed around the world, and uses a messenger RNA (mRNA) technology, which uses fragments of RNA collected from the virus to help the body mount an immune response against future infection.
A major challenge is the stability of the vaccine, which requires that it be stored at temperatures between –70 and –80 °C. Pfizer says that it 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.
“So, this will minimize the need for long term storage anywhere,” said the company in a statement. “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.”
Pfizer and BioNTech have also 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 (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. The US and EU are expected to approve the vaccine within the coming weeks.
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.
“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, M.D., CEO and Co-founder of BioNTech. “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.”
