News ID: 277625
Published: 0352 GMT December 02, 2020

UK approves Pfizer-BioNTech coronavirus vaccine

UK approves Pfizer-BioNTech coronavirus vaccine

Britain approved Pfizer's COVID-19 vaccine on Wednesday to become the first country to formally endorse a jab it said should reach the most vulnerable people early next week.

Prime Minister Boris Johnson touted the medicine authority's approval as a global win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people worldwide, hammered the world economy and upended normal life, Reuters reported.

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time – just 23 days since Pfizer published the first data from its final stage clinical trial.

"It's fantastic," Johnson said. "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."

The approval of a jab for use almost exactly a year since the novel coronavirus emerged in Wuhan, China, is a triumph for science, American drugmaker Pfizer and its German biotechnology partner BioNTech.

But the breakneck speed at which approval was given drew criticism from Brussels where, in an unusually blunt statement, the European Union's drugs regulator said its longer procedure to approve vaccines was more appropriate as it was based on more evidence and required more checks.

British officials said that, while they would love to get a jab themselves, priority had to be given to those most in need – the elderly, those in care homes and health workers.

Pfizer said Britain's emergency use authorization marks a historic moment in the fight against COVID-19. The drugmaker announced its vaccine breakthrough on Nov. 9 with stage III clinical trial results.

"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," said Pfizer boss Albert Bourla.

Britain's medicines regulator approved the vaccine in record time by doing a "rolling" concurrent analysis of data and the manufacturing process while Pfizer raced to conclude trials.

"No corners have been cut," MHRA chief June Raine said in a televised briefing, adding that the first data on the vaccine had been received in June and undergone a rigorous analysis to international standards. "Safety is our watchword."

The US Food and Drug Administration (FDA) is set to meet on Dec. 10 to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the European Medicines Agency (EMA) said it could give emergency approval for the shot by Dec. 29.

"The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program," said Ugur Sahin, the chief executive and cofounder of BioNTech.

Britain has ordered 40 million doses of the Pfizer vaccine – enough for just under a third of the population as two shots of the jab are needed per person to gain immunity.


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