Britain approves vaccine
BRITAIN approved Pfizer’s Covid-19 vaccine yesterday, jumping ahead of the US and Europe to become the West’s first country to formally endorse an injection 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.
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.
The world’s big powers have been racing for a vaccine for months to begin the long road to recovery, and getting there first may be seen as a coup for Johnson’s government, which has faced criticism over its handling of the crisis.
“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 and get the economy moving again.”
The approval of an injection for use almost exactly a year since the novel coronavirus emerged in Wuhan, China, is a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.
But the breakneck speed at which approval was given drew criticism from Brussels where, in an unusually blunt statement, the EU’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 leaders said that, while they would love to get an injection themselves, priority had to be given to those most in need – the elderly, those in care homes and health workers.
The US drug-maker said Britain’s emergency use authorisation marked a historic moment in the fight against Covid-19. Pfizer announced its vaccine breakthrough on November 9 with stage III clinical trial results.
“This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for its ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said chief executive 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 from Downing Street, adding that the first data on the vaccine had been received in June and had undergone a rigorous analysis to international standards. “Safety is our watchword.”
“With 450 people dying of Covid19 every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks,” said Andrew Hill, senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.
The US Food and Drug Administration (FDA) is set to meet on December 10 to discuss whether to recommend emergency use authorisation of the Pfizer/BioNTech vaccine, and the European Medicines Agency (EMA) said it could give emergency approval for the shot by December 29.
“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme,” said Ugur Sahin, the chief executive and co-founder of BioNTech. The company said it expected the FDA and EMA to make a decision in mid December.
Anti-poverty campaigners, meanwhile, warned against rich countries hoarding vaccines at the expense of poorer ones.
“The worst thing we can do at this moment is allow a small number of countries to monopolise access to vaccines like this,” said Romilly Greenhill, UK director of the ONE organisation.
Britain said it would start vaccinating those most at risk of dying early next week after it gets 800 000 doses from Pfizer.