UK becomes first nation to approve Pfizer and BioNTech’s COVID-19 vaccine

pharmafile | December 2, 2020 | News story | Research and Development, Sales and Marketing COVID-19, Pfizer, UK, Vaccine 

The UK has become the first country worldwide to authorise Pfizer and BioNTech’s promising COVID-19 vaccine, the UK Government has announced, marking the first approval for such a therapy in the Western world.

The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) approved the therapy, known as BNT162b2, for temporary emergency use under a rolling review which incorporated the latest Phase 3 data boasting an efficacy rate of around 95% for the candidate.

“This 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 UK Department of Health and Social Care said in a statement. “The Joint Committee on Vaccination and Immunisation will shortly also 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.”

Prime Minister Boris Johnson remarked via Twitter: “It’s fantastic that the MHRA has formally authorised the Pfizer BioNTech vaccine for COVID-19. “The vaccine will begin to be made available across the UK from next week. It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”

The vaccine is due to be rolled out via the NHS as early as next week, with an estimated 800,000 doses expected to be available. The UK has reserved 40 million doses in total from the drug’s makers.

However, it will take until Spring next year before enough doses of the therapy can be distributed among all those vulnerable patients who need it, according to England’s Chief Medical Officer Chris Witty.

Matt Fellows

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