The United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2. This makes the first Western Emergency Use Authorization for a COVID-19 vaccine—vaccines are being distributed in China and Russia by their respective governments.
“Today’s Emergency Use Authorization in the UK marks a historic moment in the fight against COVID-19,” said Albert Bourla, chairman and chief executive officer of Pfizer. “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. 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 U.S. EUA submission from Pfizer-BioNTech was delivered to the U.S. Food and Drug Administration (FDA) on November 20. The agency has a vaccine advisory committee meeting scheduled for December 8, 9 and 10, with an approval expected as early as December 10 or within a few days afterwards. Dosing could begin within 24 hours after EUA approval.
Moderna submitted their EUA to the FDA on Monday, November 30, and have an advisory committee meeting scheduled for December 17.
Pfizer has indicated it will begin shipping limited supplies of the vaccine to the UK immediately and has been scaling up for even wider distribution if the FDA approves the EUA in the U.S. However, manufactured doses are still in limited supply. The UK has ordered about 40 million doses of the Pfizer-BioNTech vaccine, enough for 20 million people, but all are unlikely to be delivered before the end of the year.
UK Health Secretary Matt Hancock told the BBC that an initial 800,000 doses, enough for 400,000 people, will be available in the UK next week and “we’ll then deploy it at the speed that it’s manufactured” by the companies’ factory in Belgium. The majority of the rollout will come in 2021.
The UK government indicates first priority for the vaccine will be frontline healthcare workers and nursing home residents, followed by older adults.
The UK health department stated that the authorization “follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness. The Joint Committee on Vaccination and Immunisation (JCVI) will shortly publish its latest advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.”
Hancock told Sky News that in the UK distribution would be “a combination of three modes of delivery.”
The first is to hospitals, with 50 equipped to handle the vaccine and are now waiting for delivery of the doses. Second will be vaccination centers, which are being set up now, before the third level, a “community rollout” that will include doctors’ offices and pharmacists.
The Pfizer-BioNTech vaccine requires storage at -94 degrees F (-70 degrees C), which requires special handling and freezers. Neither the Moderna nor AstraZeneca-University of Oxford vaccine candidates require as cold a storage or specialized handling, but have not been authorized for use yet. The Moderna vaccine is undergoing rolling submissions in the UK, as is the AstraZeneca-Oxford candidate. They are also being reviewed in the same fashion by the European Medicines Agency (EMA).
Ugur Sahin, chief executive officer of BioNTech, the company that originally developed the vaccine, said, “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. 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 scientific rigorous and highly ethical research and development program.”
The UK health department added a cautionary note that the public needs to continue with safety precautions such as social distancing, masking and handwashing. It stated, “To aid the success of the vaccination program it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS to do its work without being overwhelmed.”
It added, “The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large scale vaccination programs and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.”
Pfizer and BioNTech have manufacturing facilities in Kalamazoo, Michigan; Mainz and Idar-Oberstein, Germany; and Puurs, Belgium. The Puurs site will be the primary site for UK distribution and European supply, but also act as backup to the Kalamazoo site for the U.S. market. BioNTech indicates it will increase its manufacturing capacity in 2021 after a third German site will begin production.
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