Britain Grants Pfizer Coronavirus Vaccine Emergency Authorization

 

Britain Grants Pfizer Coronavirus Vaccine Emergency Authorization became the first country to grant emergency approval on Wednesday to the coronavirus vaccine developed by the Pfizer and BioNTech, smashing all speed records to see a potentially lifesaving shot invented, tested and approved in less than a year.

British officials said a mass immunization program would begin almost immediately, with distribution of the vaccine expected to begin next week.

The British government said the first people to receive the vaccine would be the most vulnerable to covid-19, and so at the head of the line will be the residents of nursing homes and their caregivers. In Britain, like the United States, residents of these homes suffered high rates of mortality, especially in the first wave of the pandemic.

They will be followed by all those over 80 and front line medical workers. Then the over 75, the over 70s and individuals who are “clinically extremely vulnerable.”

June Raine, chief executive of British regulator, the Medicines and Healthcare Products Regulatory Agency, said the agency has been assessing and studying data from the vaccine developers in rolling reviews.

She said her staff leaped at the final results from Pfizer because they knew “time is of the essence,” but she stressed, “that doesn’t mean that any corners have been cut.

“The public can be absolutely confident the standards we have worked to are the equivalent of those around the world,” Raine added.

At a news conference in London, Munir Pirmohamed, a professor at the University of Liverpool and a government adviser, said the Pfizer data showed that there was partial immunity after the first dose and that people will be immune seven days after the second dose. The two doses are given about three weeks apart.

British officials say they will have 800,000 doses of the vaccine in the country within days, with another few million doses by the end of the year. Pfizer has said it can supply 40 million doses here in the spring.

But Britain has said it wants to immunize the whole country of 67 million — so supply will crucial.

British regulators are also reviewing for approval of a competing vaccine made by Oxford University and the British-Swedish pharmaceutical company AstraZeneca. If approved the government has made orders for 100 million doses from AstraZeneca. There’s also 7 million doses on pre-order from another front-running vaccine candidate made by Moderna.

Britain’s swift action drew some blowback from the European Union’s drug regulator, which said that it believed its slower and more careful approval process was the “most appropriate regulatory mechanism for use in the current pandemic emergency.”

It said that the full approval process allows for a more extensive evaluation of the data and imposes more legal requirements for safety, quality and efficacy of the vaccine on drug manufacturers.

The regulator, the European Medicines Agency, is reviewing both Pfizer and Moderna’s vaccines, but does not expect to take action before the end of December.

Britain has left the European Union but remains subject to many of its regulations, including those on drugs, until Dec. 31. But E.U. rules allow individual countries to authorize unlicensed drugs during emergencies.

In a statement, Britain’s Department of Health and Social Care said that the decision to approve the vaccine “follows months of rigorous clinical trials and a thorough analysis of the data” by a panel of experts who concluded that it met the standards for safety and effectiveness. Data previously released from large-scale clinical trials showed that the vaccine had nearly 95 percent efficacy and people who were immunized displayed no serious side effects.

Britain has been racing to become the first Western country to approve a coronavirus vaccine.

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

“Help is on its way,” British Health Secretary Matt Hancock tweeted on Wednesday. “The NHS stands ready to start vaccinating early next week.”

Hancock told the BBC that he was “absolutely thrilled” by the decision and “very proud” that Britain was the first country to approve the vaccine.

Pfizer CEO Albert Bourla described the vaccine’s authorization as “a historic moment,” and noted that the company anticipates that it will soon be approved by other governments around the world. Pfizer and BioNTech filed for emergency use authorization in the United States on Nov. 20, with the goal of distributing the vaccine to high-risk populations by mid-December.

Drug regulators in Britain, where being first to launch a mass vaccination effort would be a point of national pride, have a reputation for being tough but quick-moving. Their decision is likely to intensify the focus on the U.S. Food and Drug Administration, which has faced increasing pressure from the Trump administration to approve Pfizer’s vaccine. On Tuesday, White House Chief of Staff Mark Meadows summoned Stephen Hahn, the head of the FDA, to ask why the agency was not moving faster.

Antonia Noori Farzan in Newport, Rhode Island contributed to this report.

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