Pfizer's vaccine granted emergency OK in Britain

Britain's Health Secretary Matt Hancock gestures as he 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)
Britain's Health Secretary Matt Hancock gestures as he 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)

LONDON -- Britain gave emergency authorization Wednesday to Pfizer's coronavirus vaccine, becoming the first Western country to allow mass inoculations against a disease that has killed more than 1.4 million people worldwide.

In giving the go-ahead for emergency use of the vaccine developed by American drugmaker Pfizer and Germany's BioNTech, Britain vaulted past the United States by at least a week. The U.S. Food and Drug Administration is not scheduled to consider the vaccine until Dec. 10.

"This is a day to remember, frankly, in a year to forget," British Health Secretary Matt Hancock said.

The announcement set the stage for the biggest vaccination campaign in British history and came just ahead of what experts are warning will be a long, dark winter, with the coronavirus surging in recent weeks in the U.S. and Europe.

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Officials cautioned that several tough months still lie ahead even in Britain, given the monumental task of inoculating large swaths of the population. Because of the limited initial supply, the first shots will be reserved for those most in danger, namely nursing home residents, the elderly and health care workers.

Britain's Medicines and Healthcare Products Regulatory Agency recommended the vaccine after clinical trials involving tens of thousands of volunteers showed it was 95% effective and turned up no serious side effects. The vaccine is still considered experimental while final testing is done.

"This is an unprecedented piece of science," given that the vaccine was authorized less than a year after the virus was discovered, said David Harper, senior consulting fellow in global health at the Chatham House think tank.

Prime Minister Boris Johnson declared that the "searchlights of science" had picked out the "invisible enemy," which has caused close to 60,000 deaths in Britain.

Other countries aren't far behind: Regulators in not only the U.S. but the European Union and Canada also are vetting the Pfizer vaccine along with a shot made by Moderna. British and Canadian regulators are also considering a vaccine made by AstraZeneca and Oxford University.

Amid growing concern that Americans will greet vaccines with skepticism, U.S. Health and Human Services Secretary Alex Azar said Britain's decision "should give Americans additional confidence in the quality of such a vaccine." The virus has killed more than 273,000 people in the U.S. On Wednesday, the head of the U.S. Centers for Disease Control and Prevention signed off on an expert panel's recommendation that health care workers and nursing home residents be the first to be vaccinated when shots become available.

Hancock said Britain will begin receiving the first shipment of 800,000 doses from Belgium within days, and people will start getting the shots as soon as it arrives. Two doses three weeks apart are required. The country expects to receive millions of doses by the end of this year, Hancock said, though the exact number will depend on how fast it can be manufactured and checked for quality.

BioNTech, which owns the vaccine, said it has so far signed deals to supply 570 million doses worldwide in 2021, with options to deliver 600 million more. It hopes to supply at least 1.3 billion in 2021.

That is only a fraction of what will be needed as public health officials try to vaccinate much of the world's population. Experts have said several vaccines will be required to quickly end the pandemic, which has infected more than 64 million people globally.

VACCINE CAMPAIGNS

In Britain, the first shots will go to nursing home residents and those who care for them, followed by everyone over 80 and health care workers. From there, the program will be expanded as the supply increases, with the vaccine offered roughly on the basis of age groups, starting with the oldest people.

Amid the burst of optimism, Pfizer CEO Albert Bourla warned governments against any immediate move to relax restrictions and reopen their economies.

"The time that we will have to go back to normality is not far away," he said. "But it is definitely not now."

Despite the speed with which they approved the vaccine, and the intense political pressure surrounding the worldwide race to solve the crisis, British regulators insisted that "no corners have been cut" during the review process.

The Medicines and Healthcare Products Regulatory Agency made its recommendation after a so-called rolling review that allowed it to assess information about the vaccine as it came in, starting in October.

"The safety of the public will always come first," said Dr. June Raine, the agency's chief executive. "And I emphasize again that this recommendation has only been given by the [Medicines and Healthcare Products Regulatory Agency] following the most rigorous scientific assessment of every piece of data."

Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. China and Russia have offered different vaccines to their citizens before they had gone through large-scale, late-stage testing.

Hours after Britain's announcement, Russian President Vladimir Putin ordered the start of a large-scale covid-19 vaccination campaign by late next week, with doctors and teachers to be first in line to receive the Sputnik V shot, whose name was inspired by the 1957 satellite that was one of Moscow's proudest technical achievements.

The Russian vaccine won regulatory approval in August but has yet to complete advanced studies of its effectiveness and safety. Health Minister Mikhail Murashko said more than 100,000 people in Russia have been given the shots.

NEW GUIDANCE

Elsewhere, the CDC issued revised guidance Wednesday on its standard 14-day coronavirus quarantines, shortening the duration to 10 days or even seven in some cases, in an effort to boost compliance.

The 14-day quarantine recommendation from the CDC remains in effect, but the revised guidance being given to public health agencies offers two "acceptable alternative quarantine periods," Henry Walke, the CDC incident manager for the coronavirus, said in a news briefing. If a community has adequate testing resources, then the quarantine can end after just seven days if a person tests negative for the virus at some point in the final two days of that period. The test can be either a rapid-response antigen test or the more reliable polymerase chain reaction, or PCR, test that takes longer to process.

Alternatively, the quarantine can end after 10 days without a test if a person monitors any potential symptoms, such as fever, on a daily basis and has none. The exposed person is expected to continue monitoring symptoms and wearing a mask for the full 14 days despite discontinuing quarantine.

The move reflects the agency's recognition that the two-week quarantine rule is onerous for many people and that most of the public health benefit from quarantining people exposed to the virus can be gained with a more flexible approach.

CDC officials also announced new guidance for testing before and after traveling: Someone planning a trip should get a test one to three days in advance and then be tested again three to five days after returning. And the agency reiterated its pre-Thanksgiving recommendation against travel this holiday season amid a large spike in coronavirus infections nationwide that is filling hospitals with covid-19 patients and claiming an average of more than 1,500 lives every day.

"Cases are rising. Hospitalizations are increasing. Deaths are increasing. We need to try to bend the curve, stop this exponential increase," Walke said. He emphasized the importance of preventing the initial infections: "We're really asking the American public to prevent these infections, avoid travel, wash their hands, wear a mask and maintain distance."

The Arkansas Department of Health is "studying the CDC change in guidance and their justification for it," spokeswoman Danyelle McNeill said Wednesday.

Gov. Asa Hutchinson later announced that he would hold a news conference on the guidance today.

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ANTIBODY TREATMENT

Additionally, CVS announced Wednesday that it reached a deal with the federal government to give out a covid-19 antibody treatment in patients' homes and long-term care facilities, providing a new way for certain high-risk patients to get a drug aimed at keeping them out of the hospital.

The treatment, called bamlanivimab and developed by Eli Lilly, has been administered mainly at hospitals since it received emergency authorization from the FDA less than a month ago. Since then, the federal government has distributed to state health departments nearly 170,000 doses of the treatment, although only some of those doses have been given to patients so far. The federal government has purchased 950,000 doses to last into January, including the doses that have already been distributed.

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The three-month pilot with CVS involves just 1,000 doses, enough to treat 1,000 covid-19 patients. It's not clear how much effect that will have as the virus is spreading rapidly and demand for treatments is surging.

"Even with this partnership, we're talking about a very limited resource," said Dr. Robert Goldstein, an infectious disease physician at Massachusetts General Hospital. "We still don't have a way to deliver it equitably, and I'm not sure that the CVS partnership is necessarily going to improve equity in distribution."

The program will be limited for now to seven metropolitan areas: Boston, Chicago, Cleveland, Los Angeles, Milwaukee, Minneapolis and Tampa, Fla. Those sites were chosen based on factors including their location, infrastructure and clinical capacity, said Michael Pratt, a spokesman for the Department of Health and Human Services.

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Information for this article was contributed by Lauran Neergaard, Danica Kirka, Frank Jordans, Jill Lawless, Pan Pylas and Jo Kearney of The Associated Press; by Benjamin Mueller and Rebecca Robbins of The New York Times; by Joel Achenbach of The Washington Post; and by Andy Davis of the Arkansas Democrat-Gazette.

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)
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)
A vaccination proband sits in the vaccination cabi in Mainz, Germany, Wednesday, Dec.2, 2020.. The Minister of Health in Rhineland-Palatinate visited a trial vaccination centre. In order to test the structure, organisation and procedures with possible vaccinations against Covid-19, Rhineland-Palatinate has set up a trial vaccination centre in the state capital. (Andreas Arnold/dpa via AP)
A vaccination proband sits in the vaccination cabi in Mainz, Germany, Wednesday, Dec.2, 2020.. The Minister of Health in Rhineland-Palatinate visited a trial vaccination centre. In order to test the structure, organisation and procedures with possible vaccinations against Covid-19, Rhineland-Palatinate has set up a trial vaccination centre in the state capital. (Andreas Arnold/dpa via AP)
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)
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)
People queue up as they wait for the Selfridges department 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)
People queue up as they wait for the Selfridges department 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)
People carry shopping bags 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)
People carry shopping bags 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)
Face masks to curb the spread of coronavirus are displayed for sale on a stall 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)
Face masks to curb the spread of coronavirus are displayed for sale on a stall 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)
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)
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)
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)
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)
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)
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)