FILE - This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic. (Courtesy of University of Maryland School of Medicine via AP, File)
The Associated Press
British officials authorized a COVID-19 vaccine for emergency use on Wednesday, greenlighting the world's first shot against the virus that's backed by rigorous science and taking a major step toward eventually ending the pandemic.
The go-ahead for the vaccine developed by American drugmaker Pfizer and Germany's BioNTech comes as the virus surges again in the United States and Europe, putting pressure on hospitals and morgues in some places and forcing new rounds of restrictions that have devastated economies.
The Medicines and Healthcare Products Regulatory Agency, which licenses drugs in the U.K., recommended the vaccine could be used after it reviewed the results of clinical trials that showed the vaccine was 95% effective overall - and that it also offered significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental while final testing is done.
'œHelp is on its way,'' British Health Secretary Matt Hancock told the BBC, adding that the situation would start to improve in the spring.
'œWe now have a vaccine. We're the first country in the world to have one formally clinically authorized but, between now and then, we've got to hold on, we've got to hold our resolve," he said.
Other countries aren't far behind: Regulators in the United States and the European Union also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna Inc. British regulators also are considering another shot made by AstraZeneca and Oxford University.
Hancock said Britain expects to begin receiving the first shipment of 800,000 doses 'œwithin days,'' and people will begin receiving shots as soon as the National Health Service gets the vaccine.
Doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.
A government committee will release details of vaccination priorities later Wednesday, but Hancock said nursing home residents, people over 80, and healthcare workers and other care workers will be the first to receive the shot.
Pfizer said it would immediately begin shipping limited supplies to the U.K. - and has been gearing up for even wider distribution if given a similar nod by the U.S. Food and Drug Administration, a decision expected as early as next week.
Pfizer CEO Albert Bourla called the U.K. decision 'œa historic moment.'ť
'œWe are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,'ť Bourla said in a statement.
While the U.K. has ordered 40 million doses of the Pfizer vaccine, enough for 20 million people, it's not clear how many will arrive by year's end. Hancock said the U.K. expects to receive 'œmillions of doses" by the end of this year, adding that the actual number will depend on how fast Pfizer can produce the vaccine.
One concern about the Pfizer-BioNTech vaccine is that it must be stored and shipped at ultra-cold temperatures of around minus 70 degrees Celsius (minus 94 degrees Fahrenheit), adding to the challenge of distributing the vaccine around the world.
Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS-enabled sensors will allow the company to track each shipment and ensure they stay cold, the company says.
'œPfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months," the company said in a statement.
The company also says it has agreed to work with other vaccine makers to ensure there is sufficient supply and a range of vaccines, 'œincluding those suitable for global access.'ť
Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to roll out a rigorously scientifically tested shot colored the race in the U.S. and Britain, even as researchers pledged to cut no corners. In contrast, China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.
The shots made by U.S.-based Pfizer and its German partner BioNTech were tested in tens of thousands of people. And while that study isn't complete, early results suggest the vaccine is 95% effective at preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who'd received the actual vaccine and the rest had gotten a dummy shot.
'œThis is an extraordinarily strong protection,'ť Dr. Ugur Sahin, BioNTech's CEO, recently told The Associated Press.
The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.
Final testing must still be completed. Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.
The vaccine also has been tested in only a small number of children, none younger than 12, and there's no information on its effects in pregnant women.
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Britain's Health Secretary Matt Hancock arrives at Downing Street in London, Wednesday, Dec. 2, 2020. U.K. Health Secretary Matt Hancock on Wednesday thanked scientists from Pfizer and BioNTech after the approval of their COVID-19 vaccine for emergency use by the country's drugs regulator. Speaking earlier Hancock gave details of how the vaccine would be distributed from the beginning of next week. (AP Photo/Kirsty Wigglesworth)
The Associated Press
Two workers wave from a window at Pfizer Manufacturing in Puurs, Belgium, on Wednesday, Dec. 2, 2020. British officials authorized a COVID-19 vaccine for emergency use on Wednesday, greenlighting the world's first shot against the virus that's backed by rigorous science and taking a major step toward eventually ending the pandemic. (AP Photo/Virginia Mayo)
The Associated Press
A truck leaves Pfizer Manufacturing in Puurs, Belgium, on Wednesday, Dec. 2, 2020. British officials authorized a COVID-19 vaccine for emergency use on Wednesday, greenlighting the world's first shot against the virus that's backed by rigorous science and taking a major step toward eventually ending the pandemic. (AP Photo/Virginia Mayo)
The Associated Press
People wait for a Foot Locker store to open as non-essential shops are allowed to reopen after England's second lockdown ended at midnight, on Oxford Street, in London, Wednesday, Dec. 2, 2020. Pfizer and BioNTech say they've won permission Wednesday for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science, and a major step toward eventually ending the pandemic. (AP Photo/Matt Dunham)
The Associated Press
This handout photo taken in Oct. 2020 and provided by Pfizer shows part of a "freezer farm," a football field-sized facility for storing finished COVID-19 vaccines, in Puurs, Belgium. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic. (Pfizer via AP)
The Associated Press
FILE - In this Nov. 9, 2020, file photo, an ad for COVID-19 testing reflects on glass at a bus stop, as pedestrians walk past Pfizer world headquarters in New York. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic. (AP Photo/Bebeto Matthews, File)
The Associated Press
FILE - In this Monday, Nov. 9, 2020, file photo, a sign with the Pfizer logo stands outside the corporate headquarters of Pfizer Canada in Montreal. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic. (Ryan Remiorz/The Canadian Press via AP, File)
The Associated Press
In this undated photo released by Pfizer on Tuesday, Dec. 1, 2020, a thermal shipping box for a COVID-19 candidate vaccine developed by BioNTech and Pfizer is shown in front of a freezers at the company headquarters in Puurs, Belgium. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic. (Pfizer via AP)
The Associated Press
FILE - In this Nov. 9, 2020, file photo, a general view of Pfizer Manufacturing Belgium in Puurs, Belgium. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic.(AP Photo/Virginia Mayo, File)
The Associated Press
Britain's Health Secretary Matt Hancock arrives at Downing Street in London, Wednesday, Dec. 2, 2020. U.K. Health Secretary Matt Hancock on Wednesday thanked scientists from Pfizer and BioNTech after the approval of their COVID-19 vaccine for emergency use by the country's drugs regulator. Speaking earlier Hancock gave details of how the vaccine would be distributed from the beginning of next week. (AP Photo/Kirsty Wigglesworth)
The Associated Press
File -- In this Tuesday, Nov.10, 2020 file photo windows are illuminated at the headquarters of the German biotechnology company BioNTech in Mainz, Germany. Pfizer and BioNTech say they've won permission Wednesday, Dec. 2, 2020, for emergency use of their COVID-19 vaccine in Britain, the world's first coronavirus shot that's backed by rigorous science -- and a major step toward eventually ending the pandemic.(AP Photo/Michael Probst, file)
The Associated Press
Two workers stand in a window at Pfizer Manufacturing in Puurs, Belgium, on Wednesday, Dec. 2, 2020. British officials authorized a COVID-19 vaccine for emergency use on Wednesday, greenlighting the world's first shot against the virus that's backed by rigorous science and taking a major step toward eventually ending the pandemic. (AP Photo/Virginia Mayo)
The Associated Press