UK first western nation to OK Pfizer’s vaccine
Initial doses will go to most vulnerable people
LONDON – The United Kingdom became the first western country to approve widespread use of a COVID-19 vaccine developed by drug companies Pfizer and BioNTech, the British government said Wednesday.
The Medicines and Healthcare products Regulatory Agency said the first shots will be given next week. Studies show it is up to 95% effective.
The move makes the U.K. one of the first countries to begin vaccinating its population as it tries to curb Europe’s deadliest COVID-19 outbreak. It comes as several pharmaceutical companies are poised to distribute vaccines to combat a disease that has killed nearly 1.5 million people worldwide and sickened tens of millions more.
The first doses in the U.K. will go to the most vulnerable.
Other countries aren’t far behind: The United States and the European Union are vetting the Pfizer/BioNTech shot along with a similar vaccine made by competitor Moderna.
China and Russia have already begun a mass rollout of their own coronavirus vaccines. But they have done so before completing late-stage clinical trials.
The Pfizer/BioNTech vaccine took 10 months to go from concept to distribution. The development of a vaccine typically takes about a decade.
The companies said they would immediately begin shipping limited supplies to the U.K., which has ordered enough of the vaccine for 20 million people.
They are also gearing up for even wider distribution if given a similar nod by the U.S. Food and Drug Administration. A decision in the U.S. is expected as early as next week.
But doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.
The vaccine is manufactured in Belgium.
Still, Pfizer CEO Albert Bourla called the U.K. decision “a historic moment.”
“We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla said in a statement.
“Help is on the way,” U.K. Health Secretary Matt Hancock tweeted.
In a news conference, Prime Minister Boris Johnson hailed the vaccine’s rollout but cautioned not “to get carried away with over-optimism” because it could be “some months before all the most vulnerable are protected.”
Two doses, three weeks apart, are required for protection. One of the distribution challenges is that the vaccine must be stored at ultra-cold temperatures.
The U.K. government said front-line health care workers and nursing home residents, followed by older adults, will get the vaccine first.
British regulators also are considering another shot made by AstraZeneca and Oxford University. But Johnson has warned that “we must first navigate a hard winter” of restrictions to try to curb the virus until there’s enough vaccine to go around.
The AstraZeneca/Oxford University vaccine has faced questions from scientists after the company said some of its trial participants mistakenly received only a partial dose. The disclosure has undermined confidence in the results of its trials.
Every country has different rules for determining when an experimental vaccine is safe and effective enough to use. Researchers have pledged to cut no corners.
“The safety of the public will always come first,” said June Raine, head of Medicines and Healthcare products Regulatory Agency, the U.K.’s federal regulator.
The shots made by U.S.-based Pfizer and its German partner BioNTech were tested on tens of thousands of people. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who had received the actual vaccine. The rest had gotten a dummy shot.
“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO, recently told The Associated Press.
The companies reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.
But experts caution that a vaccine cleared for emergency use is still experimental and that final testing must 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.