LONDON (Financial Times) -- The U.K. has become the first country to approve a COVID-19 vaccine after large-scale clinical trials and will make the shot from BioNTech and Pfizer available for the first round of inoculations next week.
Germany's BioNTech and U.S. pharmaceutical company Pfizer said doses of the vaccine would be delivered to the U.K. in the coming days after the U.K.'s Medicines and Healthcare products Regulatory Agency announced the approval on Wednesday morning.
The BioNTech/Pfizer shot is 95% effective in preventing the disease, according to data released last month from the companies' Phase 3 trial, which involved more than 43,000 people.
"This is unquestionably good news but it is not the end of the story," Boris Johnson, U.K. prime minister, told members of parliament. Johnson has said the shot will be made available across the country from "next week," but cautioned that vaccinations would take time.
The inoculation, which uses novel mRNA technology, is still under review by U.S. and EU regulators. A decision from the U.S. Food and Drug Administration is expected in mid-December, but the Amsterdam-based European Medicines Agency has said it is unlikely to approve the jab until the end of the month.
China and Russia have approved COVID-19 vaccines for early or limited use but both countries authorized the shots without waiting for the results of Phase 3 trials, provoking criticism from some experts who cautioned that the rushed process was risky.
The MHRA approved the BioNTech/Pfizer shot following "an extremely thorough and scientifically rigorous review of all the evidence," said June Raine, the agency's chief executive. "The public can be absolutely confident that the standards we have worked to are equivalent to those around the world."
Britain was the first country to reach an agreement with BioNTech/Pfizer for the supply of vaccines, ordering 30 million doses in July. It has since signed a deal for a further 10 million doses. About 10% of the U.K.'s total order is expected to be delivered before the end of the year.
"We believe that the rollout of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized," said Ugur Sahin, co-founder and chief executive of BioNTech.
Under provisional plans released by the U.K. government last month, the vaccine -- which requires two shots, at least 21 days apart -- will first be made available to care home residents and staff, before being administered to those aged over 80 and to frontline health workers.
Wei Shen Lim, chair of the U.K.'s Joint Committee on Vaccination and Immunization, confirmed that order of priority. The first phase would then be extended to younger age brackets eventually including all those over 50, and those aged between 16 and 64 with underlying health conditions, he said. "We hope 90%-99% of people at risk of dying from COVID-19 will be included or covered."
The U.K. is due to leave the EU's regulatory framework when the Brexit transition period ends on Dec. 31. It was able to approve the vaccine earlier than the rest of Europe by using a longstanding regulatory provision that allows it to diverge from the EMA in the case of urgent public need.
The MHRA is also examining data on vaccines developed by the U.S. biotech company Moderna and the partnership between the University of Oxford and AstraZeneca. In total, the British government has secured 357 million doses of seven separate vaccines.