LONDON (Reuters) – Britain has formally asked its medical regulator, the MHRA, to assess the suitability of the Pfizer-BioNTech COVID-19 vaccine, the first step in making the shot available outside the United States.
The UK has ordered 40 million doses of the vaccine, which has been shown to be 95% effective in preventing the spread of a virus that has killed more than 1
Britain’s health minister, Matt Hancock, said the government had taken the step after the two companies applied for emergency use permits in the United States.
“It has given us confidence … to formally start the process here,” he told a news conference.
“This is another important step forward in tackling this pandemic,” he said. “If a vaccine is approved, it will of course be available throughout the UK from our NHS (National Health Service), free of charge at the time of delivery as needed and not solvency.”
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Hancock said Pfizer-BioNTech has already begun providing data to the medical regulator and will submit more in the coming days.
Pfizer spokesman Andy Widger said the company continues to work closely with the MHRA and is in the process of providing the data so the regulator can make a full assessment.
The MHRA has launched an accelerated review of the shot to speed up the process of approving a successful vaccine in the country by allowing researchers to submit results in real time without waiting for studies to be completed.
The aim of the “ongoing reviews” is to accelerate the evaluations of promising medicines during the pandemic, while maintaining the same standards of safety and efficacy.
The UK expects to have 10 million doses of the vaccine, enough to protect 5 million people, by the end of the year if regulators approve it.
Health officials stressed that the MHRA was independent and highly respected. Jonathan Van Tam, England’s deputy director, said the MHRA would work “at the speed of science”.
Reporting by Kate Holton and Elizabeth Piper in London, further reporting by Carl O’Donnell in New York; editing by Stephen Addison and Matthew Lewis and Kirsten Donovan