Britain grants Pfizer coronavirus vaccine emergency authorization

British officials said a mass immunization program would begin almost immediately, with distribution of the first 800,000 doses to begin next week in a remarkable rollout of an entirely new kind of vaccine, built with a few bits of RNA, that must be stored and shipped at Antarctic temperatures.

Drug regulators in Britain have a global reputation for being tough but quick-moving, but Wednesday's 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.

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. According to the Office for National Statistics, over 17,000 people - 27 percent of coronavirus-related deaths in England and Wales - have died in nursing homes.

The care home residents 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."

At a Downing Street news conference, June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency, said that the regulator had "absolute confidence" in the "safety, effectiveness and quality" of the vaccine.

"No stone has been left unturned," she said.

"If you are climbing a mountain, you prepare and prepare. We started that in June. By the time the interim results became available on November 10 we were at base camp and then when we got the final analysis we were ready for that last sprint that takes us to today."

Wei Shen Lim, chair of the Joint Committee on Vaccination and Immunisation, said Britain was prioritizing those most at risk of dying from the virus, those who are most vulnerable, and health-care workers. He said that the order of who gets a jab first is unrelated to lockdown tiers where people live.

Munir Pirmohamed, a professor at the University of Liverpool and an independent adviser to the government, 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.