In a press release, the U.K. government said that the approval was issued after it accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) which found that the vaccine met its “strict standards of safety, quality and effectiveness.”
The vaccine will be available across the U.K. starting next week and the country’s public healthcare system, the National Health Service (NHS), will administer it to those eligible for inoculation.
U.K. Health Secretary Matt Hancock told the BBC that people will be contacted by the NHS when it is their turn to receive the vaccine.
Britain will receive 10 million doses of the vaccine soon, with the first 800,000 doses arriving in the coming days, the BBC report adds.
British approval of the vaccine comes before the U.S. and the European Union, both of whom have already received submissions from Pfizer-BioNTech.
To date, Covid-19 vaccines in China and Russia have received limited approval for use within those countries without the completion of key large-scale phase-3 trials.
40 million. That’s the total number of doses of the Pfizer-BioNTech vaccine that the U.K. has agreed to procure, enough to inoculate 20 million people as it requires two doses.
The Pfizer-BioNTech vaccine is an mRNA (messenger RNA) vaccine that uses genetic fragments from the Covid-19 virus to trigger the body into making antibodies for Covid-19 and protect the recipient from the disease. The U.K. approval of the Pfizer-BioNTech vaccine is the first time an mRNA vaccine has been approved by a regulatory body. Moderna’s vaccine, which is also seeking approval following phase-3 trials, also uses mRNA technology.
Calling the approval “fantastic” British Prime Minister Boris Johnson tweeted: “It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”
Last month, Pfizer-BioNTech announced that their vaccine is 95% effective in preventing Covid-19, according to data from its phase-3 trial, which involved more than 43,000 people. The companies have said that they expect to be able to produce 50 million doses in 2020, enough to vaccinate 25 million people, and up to 1.3 billion doses by the end of 2021. Late last month, Public Health England had laid out provisional plans on how the vaccine will be delivered and which populations will get priority. As per the plan, the vaccine will first be made available to residents and staff of nursing homes, followed by those aged over 80 and frontline health workers.
On Tuesday, the European Union’s drug regulator — the European Medicines Agency (EMA) — announced that it will conduct its formal assessment for the Pfizer-BioNTech on December 29. However, various member states in the bloc have reportedly been pressuring the EMA to align its approval with the U.S. and Britain. The U.K.’s decision to approve the Pfizer-BioNTech vaccine has come despite the fact that the U.K. is still technically subject to the EMA’s regulatory process until December 31 when the Brexit transition will be completed. Meanwhile, the pressure is on for the U.S. Food and Drug Administration to approve the Pfizer vaccine, with the White House reportedly questioning FDA commissioner Stephen Hahn this week on its progress.