The United Kingdom on Wednesday became the first country to clear a COVID-19 vaccine for emergency use, allowing Pfizer and its German partner, BioNTech, to start providing their experimental vaccine to people most at risk for catching the virus or becoming severely ill.
The decision by Britain’s drug regulator, the Medicines and Healthcare products Regulatory Agency, means the companies can immediately start supplying 40 million doses ― enough for 20 million people, since the vaccine requires two shots injected three weeks apart. Vaccinations are expected to start next week, the agency said, and will target the elderly, health care workers, and “the clinically extremely vulnerable.”
“Help is on its way,” Matt Hancock, Britain’s secretary of state for health and social care, tweeted Wednesday.
Britain’s swift action is likely to intensify pressure on the US Food and Drug Administration, which has set a Dec. 10 advisory committee meeting to consider a similar move in the United States. The Trump administration has provided more than $12 billion through the Operation Warp Speed program to hasten development of coronavirus vaccines. During the presidential campaign, President Trump repeatedly pledged a vaccine by Election Day, prompting critics to say he was politicizing the effort.
FDA commissioner Dr. Stephen Hahn met Wednesday with White House chief of staff Mark Meadows for the second consecutive day to explain why US drug regulators have not yet approved emergency use of the Pfizer vaccine, according to multiple news reports.
White House press secretary Kayleigh McEnany said in a briefing that it was “par for the course” for Meadows to meet with Hahn “as we’re trying to save American lives with the vaccine in record time.” McEnany said the administration expects to have 40 million doses of vaccines available by the end of the year, which she called a “tremendous achievement.”
That matches a figure provided last month by Dr. Anthony Fauci, the nation’s top infectious disease expert. He predicted roughly 25 million doses of vaccine will be available from Pfizer and another 15 million doses from Cambridge-based Moderna, whose vaccine also requires two shots, injected four weeks apart.
The Pfizer-BioNTech vaccine is the first in the world to clear the three phases of clinical trials typically required by drug regulators in Europe and the United States. China and Russia have authorized coronavirus vaccines without data from a late-stage trial.
Britain’s action comes as cases of COVID-19 continue to surge, including in the United States. Since the coronavirus was first detected last December in Wuhan, a city of more than 11 million people in central China, it has infected more than 64 million people worldwide and killed more than 1.4 million, including 271,000 in the United States.
Pfizer and BioNTech said they expect other drug regulators around the world will approve their vaccine for emergency use “in the coming days and weeks.” Such authorizations allow health officials to begin limited vaccinations of people at high risk for exposure to the disease, or those most vulnerable to it, without having to go through the full approval process.
“It’s indeed the beginning of the end of the pandemic,” Ugur Sahin, chief executive of BioNTech, said on the NBC News show “Today.” He added, “I am confident that authorization in the US could also happen within the next two weeks.”
Sahin, a physician and professor at the Mainz University Medical Center in Germany, helped invent the vaccine. He became a billionaire as BioNTech’s stock price soared this year. BioNTech’s US headquarters is in Cambridge.
Albert Bourla, chief executive of Pfizer, the 171-year-old New York-based pharmaceutical giant, applauded the British drug regulator’s decision.
“With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” he said in a statement. Pfizer has a plant in Andover that is helping to make the vaccine.
Pfizer and BioNTech released data last month from a late-stage clinical trial of 43,538 participants that showed that two shots of the vaccine appeared to be about 95 percent effective at preventing the disease. Impressively, the vaccine was more than 94 percent effective in people who were 65 or older. Older people have been particularly vulnerable to severe infections of the coronavirus.
Moderna is hot on the heels of Pfizer and BioNTech. It filed applications Monday with the FDA and the European Medicines Agency for emergency use of a vaccine that the company showed was about 94 percent effective at preventing the disease. The FDA advisory committee is expected to meet about the Moderna application on Dec. 17, a week after it weighs the request by Pfizer and BioNTech.
Moderna has also asked the British drug regulator to consider a similar application to the one it approved for Pfizer and BioNTech. Moderna has an agreement with the UK to supply 7 million doses of its vaccine.
Both the Pfizer and Moderna vaccines rely on synthetic messenger RNA, a variation on the natural substance that directs protein production in cells throughout the body. The vaccines contain custom-made messenger molecules that instruct cells to create a part of the coronavirus and then stimulate the immune system to make antibodies to fend off the disease. No mRNA vaccine has ever been approved.
The Pfizer vaccine must be stored at minus-94 degrees Fahrenheit, colder than any other vaccine in development. Pfizer plans to ship it in special boxes of 1,000 to 5,000 doses that are stuffed with dry ice and equipped with GPS-enabled sensors.
The US government has bankrolled a handful of COVID-19 vaccine candidates through Operation Warp Speed. The government helped pay the cost of developing Moderna’s vaccine and pledged to buy at least 100 million doses, all for $2.48 billion.
Pfizer and BioNTech aren’t taking any money upfront from the US government. Rather, the government will pay the partners $1.95 billion for at least 100 million doses if the vaccine gets approved in the United States.
Jonathan Saltzman can be reached at email@example.com.