LONDON – Britain on Wednesday granted emergency approval to the coronavirus vaccine from pharmaceutical giant Pfizer and the German company BioNTech, becoming the first Western country to authorize mass inoculations that could lead to an end of the pandemic.
Drug regulators in Britain have a global reputation for being tough but fast, employing a system of continuous “rolling review” of incoming data from drug companies. But to see a potentially lifesaving shot invented, tested and approved in less than a year smashes all speed records.
Scientists point out that the genetic sequence of the novel coronavirus, which first struck Wuhan, China, was published only 260 days ago.
The British government, led by Prime Minister Boris Johnson, has been keen to be first in the West to roll out a vaccine – especially after months of criticism for having the highest death toll in Europe. British officials said a mass immunization program would start almost immediately, with distribution of the first 800,000 doses to begin next week.
At an evening news conference, Johnson said: “We’ve been waiting and hoping for the day when the search lights of science would pick out our invisible enemy and give us the power to stop that enemy from making us ill. And now, the scientists have done it.”
The giddy news from Britain prompted some griping in the United States and the European Union – though they may not be far behind in granting their own approval. A U.S. Food and Drug Administration advisory committee is expected to meet Dec. 10, and a decision by the agency on authorizing the vaccine could come soon after that. The EU’s drug regulator said it would make a decision by Dec. 29.
President Donald Trump expressed disappointment Wednesday that Britain approved the vaccine first, according to two White House officials who spoke on the condition of anonymity to relay private conversations. His chief of staff, Mark Meadows, met twice this week with FDA Commissioner Stephen Hahn to discuss how the vaccine could be sped up in the United States. Hahn’s job is said to be in jeopardy over his failure to further accelerate approval of the vaccine, which is already progressing in record time. The FDA declined to comment.
Meanwhile, an unprecedented surge of covid-19 hospitalizations across the United States is putting hospitals and medical staff under enormous strain. The country hit a pair of alarming coronavirus benchmarks Wednesday, surpassing 200,000 new infections and topping 100,000 covid-19 patients hospitalized – the first time the United States has reached either metric.
Experts are bracing for another wave of new cases and hospitalizations connected to Thanksgiving travel. Centers for Disease Control and Prevention Director Robert Redfield said Wednesday that the next three months could be the “most difficult time in the public health history of this nation.” He said the coronavirus death toll could reach 450,000 by February.
In an effort to increase compliance with public health guidelines, the CDC on Wednesday updated its recommendations for post-exposure quarantine from the standard 14 days to 10 or even seven days. The longer 14-day quarantine period reflects the virus’s long incubation period before symptoms appear. But the CDC said the shorter quarantine period would still cover the vast majority of infections while boosting adherence to public health recommendations and improving participation in contact tracing.
In Europe, some EU leaders suggested Britain had moved too fast – and indicated annoyance at the nationalistic tone coming from the British government.
“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, the German health minister Jens Spahn told reporters.
“It’s important that we do this to help promote trust and confidence in this authorization,” Spahn said.
In the United States, the FDA reviews all aspects of the data submitted with a vaccine application, including manufacturing and individual patient-level data. The British Medicines and Healthcare Products Regulatory Agency instead relied largely on summary data submitted by Pfizer and BioNTech, according to experts.
And British authorities did not hold a public meeting involving the Pfizer application, though it did confer with an independent expert panel on the medical assessment and conditions of authorization. The FDA, by contrast, committed months ago in the name of transparency to convene a public meeting of its vaccine advisory committee to solicit its recommendations on an emergency authorization and to make public the data that was submitted by the manufacturer.
Robert Califf, who was FDA commissioner during the Obama administration, said it was important for the U.S. regulators to have a “public airing” of the Pfizer application and data, given the level of anti-vaccine sentiment in the United States, even if it takes a little more time.
“We have a lot of skepticism and a need to follow public procedures to provide transparency,” he said.
Trump, who has sought credit for vaccine development, has consistently put pressure on regulators to hasten the availability of the vaccine – to end a pandemic that is widely believed to have harmed his political prospects and because he wants to begin distribution before President-elect Joe Biden takes office, according to the two White House officials.
In an interview, Hahn said the FDA is determined to follow a publicly announced review process that includes requiring “clear and compelling” evidence that a vaccine is safe and effective. He said the agency is adhering to criteria similar to those used for a full approval process, which typically takes several months or longer. “But our team does need the time to fulfill our obligation to the American people,” he said, adding that the FDA is known around the world as the “gold standard” for its rigorous reviews of products.
Alok Sharma, a British government deputy minister, was among those who took the opportunity Wednesday 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.”
But Spahn, the German health minister, emphasized that “BioNTech is a European development, funded by the European Union. And it showed that if a product from the European Union is so good that it is authorized so quickly in the U.K. in this crisis, what is best is European and international cooperation.”
The EU’s regulator defended its slightly slower review as ensuring “full evaluation of the data available and clear obligations with legal controls on safety, quality and efficacy.”
At a Downing Street news conference, June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency, defended the speed of the country’s approval process and said the British agency had “absolute confidence” in the “safety, effectiveness and quality” of the Pfizer and BioNTech vaccine.
“If you are climbing a mountain, you prepare and prepare,” she said. “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.”
BioNTech and Pfizer scientists, in a video call with reporters, said they have been providing the same data sets to all regulators throughout their trials, from the earliest safety data to the latest November results from large clinical trials taking place in six countries.
When asked why the FDA was moving slower, BioNTech co-founder Özlem Türeci said all regulators “have been highly committed and engaged.”
Sean Marett, the firm’s chief commercial officer, said British regulators asked “the same kind of detailed questions as any other agency.”
Berkeley Phillips, medical director of Pfizer UK, said the vaccine has been shown to be 95 percent effective in preventing covid-19, the disease caused by the coronavirus. In clinical trials that have grown to 44,000 volunteers, eight people who received the vaccine went on to get covid-19 symptoms, while 162 people who received the placebo got sick from the virus.
Meanwhile, nine out of 10 “severe” cases of the disease were in the control group who got a placebo, with only one severe case in the vaccinated group.
Phillips said, “We didn’t see any serious side effects,” and the vaccine worked well for the elderly and minorities. Britain approved the vaccine for anyone over 16 years of age.
According to Pfizer’s data, the vaccine will give partial immunity after the first dose and 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 British government. The two doses are to be given about three weeks apart.
The Pfizer vaccine will not be the first to be widely distributed. Both China and Russia have been inoculating swaths of their populations, but far less is known about the efficacies of their vaccines and how they’ve been tested.
On Wednesday, Russian President Vladimir Putin called for a “large-scale” effort to immunize doctors and teachers with the country’s Sputnik V vaccine as early as next week.
The Pfizer vaccine is the first product brought to market by BioNTech, until now a little-known German firm based in the western city of Mainz and run by a husband-and-wife team of Turkish heritage.
It is also the first vaccine of its kind to be rolled out anywhere in the world.
It deploys not a crippled virus or a bit of virus, as traditional vaccines do, but a snip of messenger RNA, delivered into muscle cells in the body. This RNA turns a body’s cell into a factory to produce replicas of the spike protein on the surface of the coronavirus. These pieces of protein – an antigen – then stimulate an immune response that produces antibodies against the virus and prepares the body to repel the virus when it comes.
“It’s a new drug entity,” BioNTech co-founder Ugur Sahin said in the Wednesday news conference.
Company officials said they would be selling doses to governments, not the private market. They have so far committed to deals with 13 countries plus the 27-member European Union through 2021.
“We set out at the beginning to deliver this vaccine to the world, and that means fair allocations to all countries,” Marett said.
The U.S. government is so far the biggest purchaser – it has preordered 100 million doses, with an option to acquire 500 million more. The EU signed an agreement for 200 million doses to be distributed among its member countries.
U.S. officials anticipate having about 40 million doses of vaccines from Pfizer and biotech firm Moderna by the end of the year, enough to immunize 20 million people.
British officials said they will have a few million doses of the Pfizer vaccine by the end of the year, with the rest by the spring. Britain has ordered 40 million doses – enough to vaccinate 20 million people. That is not enough in a country of 67 million, so supply will be crucial, and most people will have to wait months for their shot, even if other front-running vaccines are approved soon.
The first shipments will arrive in British warehouses from Pfizer’s manufacturing facility in Belgium over the weekend. The vaccine will be transported at sub-Antarctic temperatures, in packed trays of 965 doses in dry ice, making logistics are challenging.
Jonathan Van-Tam, the deputy chief medical officer for England, said the Pfizer vaccine is “not a yogurt that can be put in the fridge and taken out multiple times. . . We’re going to work as fast as we can.”
Pfizer scientists, however, said that once the vaccine arrives at final distribution points in Britain, it can be kept safely in a regular refrigerator for up to five days.
The British government said the first people to receive the vaccine should be the most vulnerable to covid-19, and so at the head of the line will be those over 80, along with nursing home residents and their caregivers.
In Britain, as in the United States and many other countries, residents of these facilities have suffered some of the 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 nursing 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. The prime minister said he hoped to inoculate all of the most vulnerable by the spring.
British regulators are also reviewing a competing vaccine made by the University of Oxford 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 the U.S. company Moderna.
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The Washington Post’s Michael Birnbaum in Riga, Latvia; Loveday Morris in Berlin; Antonia Noori Farzan in Newport, R.I.; and Josh Dawsey, Isaac Stanley-Becker, Joel Achenbach and Felicia Sonmez in Washington contributed to this report.