NEW YORK & MAINZ, Germany—Pfizer Inc. and BioNTech SE have reported that the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) has granted temporary authorization for emergency use for the COVID-19 mRNA vaccine BNT162b2.
“[The] Emergency Use Authorization in the U.K. 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 U.K.,” stated Albert Bourla, chairman and chief executive officer of Pfizer.
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 percent in participants with and without prior SARS-CoV-2 infection. Efficacy was consistent across age, gender, race and ethnicity demographics — with an observed efficacy of 94 percent in adults 65 and over.
“The Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19. 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,” added Ugur Sahin, M.D., co-founder and chief executive officer of BioNTech. “The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”
BNT162b2 was generally well tolerated in the trial, with no serious safety concerns reported by the Data Monitoring Committee to date. The decision was also based on a review of the companies’ chemistry, manufacturing and control data for the vaccine.
In July 2020, BioNTech and Pfizer reported an agreement with the U.K. to supply 30 million doses of BNT162b2, after the vaccine had been authorized for emergency use — an agreement that was increased to 40 million in October. The first doses are expected to arrive in the UK in the coming days, with complete delivery fulfillment expected in 2021.
However, there have been some concerns about vaccine storage and shipping, considering that “Pfizer’s and Moderna’s vaccines [require] environments of -70°C and -20°C, respectively,” according to Mohamed Abukar, pharma analyst at GlobalData. “These low-temperature storage requirements increase the complexity of logistics, as there may not be enough low-temperature freezers available and shipping will require tracking using GPS-enabled thermal sensors to monitor the temperature of each shipment.”
Logistical concerns aside, there is a huge demand for a COVID-19 vaccine, and other countries likely won’t be far behind the UK’s lead.
“Pressure is now on for countries to issue approvals; the FDA has scheduled public hearings for both Pfizer/BioNTech and Moderna, on 10 and 17 December, respectively. Given the urgency of the pandemic and the need for a vaccine along with the efficacy results, it is likely that these will receive approval,” Abukar adds.
BioNTech and Pfizer have filed for Emergency Use Authorization request with the FDA; the companies have also submitted the final Conditional Marketing Authorization Application, following rolling submissions with the European Medicines Agency and several other regulatory agencies around the world.
The companies anticipate further regulatory decisions across the globe in the coming weeks, and say that they are ready to deliver vaccine doses following other potential regulatory authorizations or approvals.
“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,” concluded Bourla. “With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic.”