The UK has become the first country in the world to approve Pfizer and BioNTech's coronavirus candidate 'BNT162b2'. The decision was taken after the Medicines and Healthcare Products Regulatory Agency (MHRA) found the jab safe for widespread rollout, Pfizer said. The country has already ordered 40 million doses of the Pfizer vaccine to vaccinate its 20 million population. As the coronavirus cases continue to rise in the UK, the country had planned to move quickly into the approval process.
"The MHRA in the UK has granted a temporary authorisation for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorisation following a worldwide Phase 3 trial of a vaccine to help fight the pandemic," Pfizer said in a statement. The company said the distribution of the vaccine in the UK will be prioritised according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said the company applauds the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK.
Around 10 million doses of the vaccine will be available soon, reported BBC News. The approval for Pfizer's vaccine candidate comes in only 10 months since the company started developing it, which in itself is fastest in the history of vaccines. Other countries like the US and the European Union are vetting the Pfizer and BioNTech candidate and the one developed by Moderna Inc.
Ugur Sahin, MD, CEO and Co-founder of BioNTech, said the Emergency Use Authorisation (EUA) in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against COVID-19. "We believe that the roll-out of the vaccination programme in the UK will reduce the number of people in the high-risk population being hospitalised," he said.
The MHRA's decision is based on a interim analysis of its phase 3 clinical trial data involving around 170 participants. During this analysis, the vaccine candidate demonstrated a vaccine efficacy rate of 95 per cent. The efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94 per cent, it said.
"In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today's decision also is based on a review of Pfizer's and BioNTech's Chemistry, Manufacturing and Control (CMC) data for BNT162b2," said Pfizer.
The announcement by Pfizer came after another US pharma company, Moderna Inc, claimed its vaccine was 94.5 per cent effective against COVID-19 earlier last month. So far, only China and Russia had approved the COVID-19 vaccines for general populace. The UK's drug regulator, Medicines and Healthcare Products Regulatory Agency, had earlier said it will process clearance for Pfizer vaccine in "the shortest time possible" without compromising on safety.
Notably, Pfizer, BioNTech, Moderna, and Russia's Sputnik V are the only vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, Pfizer, and BioNTech's vaccines have also raised high hopes. The Phase-3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom received a second dose of the vaccine candidate as of November 13, 2020.
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