U.K. is 1st country to approve Pfizer COVID-19 vaccine, with distribution to start

London — 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 are expected to get the first doses of the vaccine. Pfizer’s vaccine, like the Oxford and Moderna formulas, requires 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. He told the BBC Breakfast show that vaccinations would “start with the most elderly and with people in care homes.” 

Prime Minister Boris Johnson also hailed the news, confirming in a tweet plans to start rolling out doses from next week.

“It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again,” Johnson said.  

Hancock, Britain’s top public health official, noted the logistical complexities of distributing the Pfizer vaccine, which needs to be stored at around -94 degrees Fahrenheit, but said Britain would get its first 800,000 doses delivered next week. The U.K. has a total of 40 million doses of the Pfizer vaccine on order, enough to fully treat 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 to distribute as it only requires storage at 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 on Wednesday, 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 leading Western-made vaccines have found significant adverse affects. Some side effects commonly associated with long-used vaccines, including soreness around the point of injection, fatigue and headaches have been seen in the trial data.

In China and Russia, officials have been administering thousands of doses of COVID-19 vaccines developed by government-backed research institutes, outside of trials, for weeks. Unlike the Western vaccine programs, neither Russia nor China carried out large-scale, international human trials with data provided for independent analysis before starting their non-trial vaccine programs. 

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