Britain has become the first country in the West to approve a COVID-19 vaccine for public use. The U.K. Department of Health and Social Care confirmed in a statement to British news agencies that the vaccine developed jointly by American drugmaker Pfizer and Germany’s BioNTech would be distributed starting next week. Pfizer was the first of three major Western pharmaceutical companies to apply in both the U.S. and Europe for emergency use authorization.
“The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s Covid-19 vaccine for use,” a Department of Health and Social Care spokesman told the Press Association of Britain. The spokesman said the emergency use authorization followed “months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.”
In line with planning in the U.S., British front-line healthcare workers, care home residents, the very elderly and people with underlying conditions that make them particularly vulnerable to COVID-19 complications will be the first to get a dose of the vaccine. Pfizer’s vaccine, like the Oxford and Moderna formulas, require two doses about a month apart.
U.K. Health Secretary Matt Hancock called it “fantastic news” that Britain’s regulator had deemed the first vaccine safe, and vowed that distribution would begin from Monday.
Hancock noted the logistical complexities of distributing the Pfizer vaccine, which needs to be stored at temperatures well below freezing, but said Britain would get its first 800,000 doses delivered next week and that the vaccine would be distributed after that at the speed manufacturing would allow. The U.Kk. has a total of 40 million doses of the Pfizer vaccine on order, enough to fully dose 20 million people.
Two other vaccines, one developed by U.S.-based Moderna, which also requires sub-zero storage, and one made by British pharmaceutical company AstraZeneca in conjunction with Oxford University, have also applied for emergency use authorization in the U.S. and Europe.
Both Pfizer and Moderna have said that data from large-scale human trials, involving tens of thousands of people, showed their vaccines to be about 95% effective at preventing COVID-19 infection. AstraZeneca/Oxford found their vaccine, which works in a different way, was up to 90% effective with a certain dosing regimen. The Oxford-developed vaccine is much cheaper to produce and requires storage at normal refrigerator temperatures.
This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic,” Pfizer and BioNTech said in a joint statement, adding that they were “anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.”
Pfizer chief executive Albert Bourla called the U.K. move “a historic moment in the fight against COVID-19.”
None of the human trials on any of the three major Western-made vaccines have found significant adverse affects attributed to the vaccines. Some side effects commonly associated with long-used vaccines, including soreness in the arm, fatigue or headaches that subsided within a few days, were noted in the trial data.