Updated at 4:30 a.m. ET
The U.K. has formally approved Pfizer's coronavirus vaccine, becoming the first Western country to OK its use for the general public.
The British regulatory agency, the Medicines and Healthcare Products Regulatory Authority, or MHRA, announced early Wednesday the approval of the vaccine from Pfizer and the German company BioNTech for emergency use. The vaccine promises up to 95% protection against COVID-19, the disease caused by the coronavirus.
Prime Minister Boris Johnson tweeted his congratulations and said: "It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."
U.K. Secretary of State for Health and Social Care Matt Hancock tweeted Wednesday morning that the National Health Service stands ready to start vaccinating people in high-priority groups as early as next week.
News of a vaccine approval offers a glimmer of hope as the world grapples with a record-breaking third surge of COVID-19 infections. More than 63.5 million cases of COVID-19 and 1.4 million deaths of complications from the disease have been recorded around the world, according to Johns Hopkins University. The U.K. alone has experienced nearly 60,000 deaths.
"Today's Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19," Albert Bourla, chairman and chief executive officer for Pfizer, said. "As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, everyday matters in the collective race to end this devastating pandemic."
Hancock said he expects 10 million doses of the vaccine to arrive in the U.K. this year. Health care workers, older people and those who reside and work in long-term care facilities, are likely be the first in line for immunization, he said. After high-priority people are provided the two doses of the vaccine, the immunization process would go through each age group, he said.
Pfizer and BioNTech said vaccine delivery is expected to continue in stages throughout 2020 and 2021. The logistics of the rollout are made more difficult by the specialized freezers that keep the vaccine viable by cooling it to -94 degrees Fahrenheit (-70 C).
Help is on its way.— Matt Hancock (@MattHancock) December 2, 2020
The MHRA has formally authorised the Pfizer/BioNTech vaccine for Covid-19.
The NHS stands ready to start vaccinating early next week.
The UK is the first country in the world to have a clinically approved vaccine for supply.
The U.K. has already purchased 40 million doses, the pharmaceutical makers say.
Around the world
U.S. regulators have yet to approve any vaccine — a fact that has drawn criticism from President Trump. The president and his aides have privately admonished the Food and Drug Administration for not moving quickly enough to approve a vaccine, Politico reports.
The drugmakers have filed a request for emergency use authorization with the FDA and have submitted the final Conditional Marketing Authorization Application with the European Medicines Agency and several other regulatory agencies around the world.
U.S. and European regulators are expected to grant emergency use of the vaccine later this month, according to Pfizer and BioNTech.