Pfizer and BioNTech say they will immediately start supplying 40 million doses.
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 a vaccine they developed to people most at risk for catching the virus or becoming severely ill.
The drug companies have an agreement with Britain to immediately start supplying 40 million doses now that the country’s drug regulator, the Medicines and Healthcare products Regulatory Agency, has authorized emergency use. That will be enough for 20 million people, given that the vaccine requires two shots. Vaccinations are expected to start within days.
Britain’s swift action may cause embarrassment for the Trump administration, which has provided more than $12 billion through the Operation Warp Speed program to hasten development of coronavirus vaccines and has been eager to deploy one in the United States.
Dr. Stephen Hahn, commissioner of the Food and Drug Administration, was summoned to the White House on Tuesday morning by Mark Meadows, the White House chief of staff, to explain why US drug regulators have not yet approved emergency use of the Pfizer vaccine, according to multiple news reports.
Since the novel coronavirus was first detected last December in Wuhan, a city of more than 11 million people in central China, it has infected more than 63 million people worldwide and killed more than 1.4 million, according to the Johns Hopkins Coronavirus Resource Center.
Pfizer and BioNTech said they expect other drug regulators around the world will approve the partnership’s vaccine for emergency use “in the coming days and weeks.”
An advisory committee to the FDA is scheduled to consider a similar emergency use request in the United States on Dec. 10. 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.
Albert Bourla, chief executive of Pfizer, 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 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 years old or older. Older people have been particularly vulnerable to severe infections of the coronavirus.
Cambridge biotech Moderna is hot on the heels of Pfizer and BioNTech. Moderna filed applications Monday with the FDA and the European Medicines Agency for emergency use of a similar two-shot 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, exactly 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 United Kingdom 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.
Ugur Sahin, chief executive of BioNTech, said the British regulator’s authorization marks the first chance for people besides volunteers in clinical trials to get a COVID-19 vaccine.
“We believe that the rollout of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized,” said Sahin, whose company has its US headquarters in Cambridge.
Pfizer, the New York pharmaceutical giant, has a plant in Andover that is helping to make the vaccine.
It must be stored at minus 94 degrees Fahrenheit, colder than any other vaccine in development. Pfizer plans to ship the vaccine in special boxes of 1,000 to 5,000 doses that are stuffed with dry ice and equipped with GPS-enabled sensors. Pfizer’s vaccine can be stored in conventional freezers for up to five days, or in the special coolers for up to 15 days.
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 jonathan.saltzman@globe.com.
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December 02, 2020 at 02:10PM
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UK grants first emergency-use approval of a COVID-19 vaccine - BetaBoston
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