Britain first country to grant Pfizer coronavirus vaccine emergency authorization

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http://www.washingtonpost.com/video/world/uk-approves-pfizer-vaccine/2020/12/02/56a400a2-6f96-4a59-b373-5313d5790950_video.html

LONDON — Britain 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 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, it must be stored and shipped at sub-Antarctic temperatures, which might prove a challenge.

Drug regulators in Britain have a global reputation for being tough but fast, and 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 FDA Commissioner Stephen Hahn to ask why the agency was not moving faster. 

Kirsty Wigglesworth

AP

British Health Secretary Matt Hancock arrives at Downing Street in London, Dec. 2, 2020.

[Britain races to become the first Western country to approve a coronavirus vaccine]

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 some of highest rates of mortality, especially in the first wave of the pandemic. According to the Office for National Statistics, more than 17,000 people who died of covid-19 — 27 percent of all coronavirus-related deaths in England and Wales — were residents of care homes.

Wei Shen Lim, chair of the Joint Committee on Vaccination and Immunization, said Britain is prioritizing those most at risk of dying from the virus.

In the allocation lists, announced on Wednesday, the nursing home residents will be followed by all those over 80 and front-line medical workers. Next will come people over 75, those over 70 and individuals who are “clinically extremely vulnerable.” 

At a Downing Street news conference, June Raine, chief executive of the Medicines and health care Products Regulatory Agency, said 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,” she said.

“Of course, we are absolutely delighted,” Sean Marett, chief commercial officer of BioNTech, the small German firm that developed the vaccine, said of the British approval.

An FDA review is expected on Dec. 10, Marett said, while the European Union decision is expected to come in December. Speaking in a live-streamed news conference, he said Britain used its emergency temporary approval “to allow rapid distribution to a population.”

When asked why the FDA has been slower, the firm’s co-founder and vaccine developer, Özlem Türeci, said all regulators “have been highly committed and engaged.”

British regulators have asked “the same kind of detailed questions as any other agency,” said Marett.

“Help is on its way,” British Health Secretary Matt Hancock tweeted on Wednesday. “The [National Health Service] 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.

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.”

According to Pfizer’s data, the vaccine will give partial immunity after the first dose and then full protection about seven days after the second dose, said Munir Pirmohamed, a professor at the University of Liverpool and an independent adviser to the government. The two doses are given about three weeks apart.

British officials say they will have a few million doses by the end of the year. Pfizer has said it can supply 40 million doses here in the spring, enough to vaccinate 20 million people.

That is clearly not enough. Britain has said it wants to immunize the whole country of 67 million — so supply will be crucial, and most people will still have to wait months for their shot, even if other front-running vaccines are approved soon. 

British regulators are also reviewing 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. An additional 7 million doses are on preorder from another front-running vaccine candidate made by Moderna.

Matt Dunham

AP

People queue up as they wait for the Selfridges department store to open as nonessential shops are allowed to reopen after England’s second lockdown ended at midnight, on Oxford Street, in London, Dec. 2, 2020.

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

It said 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 the Pfizer-BioNTech and Moderna vaccines but does not expect to take action before the end of December.

European leaders avoided direct criticism of the British move, but some noted that they had the same option and had chosen a more careful approach, in part to improve public confidence in the vaccine and encourage as many people to use it as possible.

“We have member states, including Germany, who could have issued such emergency authorization if they wanted to, but we decided against this. And what we opted for was a common European approach to move forward together” in Europe, German Health Minister Jens Spahn told reporters as E.U. health ministers met virtually to discuss pandemic measures. “It’s important that we do this to help promote trust and confidence in this authorization.”

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.

British politicians, led by Johnson, were keen to be the first to launch a mass immunization campaign — especially after months of criticism for the high death toll in the country.

Alok Sharma, a British government deputy minister, took the opportunity to wave the Union Jack.

“The UK was the first country to sign a deal with Pfizer/BioNTech — now we will be the first to deploy their vaccine,” he tweeted. “In years to come, we will remember this moment as the day the UK led humanity’s charge against this disease.”

The German ambassador to Britain replied that this was a global effort and that the vaccine was invented by a small German firm. “Why is it so difficult to recognize this important step forward as a great international effort and success?” he tweeted. “I really don’t think this is a national story. In spite of the German company BioNTech having made a crucial contribution, this is European and transatlantic.” 

In a statement, Britain’s Department of Health and Social Care said 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 that people who were immunized displayed no serious side effects.

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.

Antonia Noori Farzan in Newport, R.I., and Michael Birnbaum in Riga, Latvia contributed to this report.

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Source: WP