The UK’s medicines regulator has approved the BioNTech/Pfizer vaccine against COVID-19 for emergency use, the companies said today.
The UK is the first country to approve the vaccine for widespread use — paving the way for some of the most “high risk” citizens, such as elderly care home residents, to get the jab before the end of the year.
The BBC reports that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has said the vaccine is safe to be rolled out from next week.
The request for emergency authorization was submitted by BioNTech and Pfizer to the MHRA last month — as well as to regulators in Australia, Canada, Europe, Japan and the U.S., none of which have yet given the go ahead.
The UK approval is based on trial data, including a worldwide Phase 3 clinical study carried out by BioNTech/Pfizer which demonstrated an efficacy rate for the vaccine of 95% and raised no serious safety concerns.
The vaccine was also shown to be effective both in participants who had not previously contracted the SARS-CoV-2 virus and those who had — based on measuring efficacy seven days after the second dose.
Efficacy was also reported as consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%, they said.
UK prime minister Boris Johnson tweeted the news of the formal authorization this morning — writing that the vaccine will “begin to be made available across the UK from next week”.
The UK has ordered 40M doses of the BioNTech/Pfizer vaccine, or enough vaccine for 20M people (as it requires two doses), though it will take time for the country to receive all the doses ordered.
“The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts,” the companies write in a press release.
“Now that the vaccine is authorized in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfilment expected in 2021,” they added.
The UK’s National Health Service is gearing up for what NHS Chief Executive, Sir Simon Stevens, described as “the largest-scale vaccination campaign in our country’s history”. Per the BBC, some 50 hospitals are on standby and vaccination centers in venues such as conference centres are being set up.