LONDON—The U.K.’s medicines regulator published its first data on the real-world safety of the two Covid-19 vaccines rolled out across the country to more than 10 million people, including 90% of its over-80-year-olds, saying it has seen no unexpected side effects from the shots and that the benefits of vaccination far outweigh the risks.
The U.K. was the first country to authorize the Pfizer Inc.-BioNTech SE shot for emergency use and had two cases of severe adverse reaction after the injection on the first day of its rollout on Dec. 8. Both people recovered.
Between Dec. 9 and Jan. 24, around 5.4 million people in the U.K. have had the Pfizer shot and 16,756, or 0.3%, of them have reported some sort of adverse reaction following the injection. Reports of adverse reactions are made via the Yellow Card system, similar to the Vaccine Adverse Effects Reporting System in the U.S.
The vast majority were mild symptoms associated with the injection such as sore arms or mild fever, the regulator said. Some 101 people reported severe allergic reactions following the injection, or fewer than one in 10,000 cases, which took place at a rate of between 1 and 2 cases per 100,000 doses given.
Similar findings for the Pfizer shot have been published in the U.S., the U.K. regulator said.
The U.K. has prioritized the elderly population and health-care workers in its vaccination rollout and has had 107 deaths following a Pfizer shot reported to the medical regulator, none of which it believes were linked to the vaccine.
The majority of these reports were in elderly people or people with underlying illness.
“Older age and chronic underlying illnesses make it more likely that coincidental adverse events will occur, especially given the millions of people vaccinated,” the regulator said in its report.
It does not monitor how many have died of Covid-19 following vaccination, but other studies are investigating those cases, said Dr. Philip Bryan, head of vaccine safety at the medicines regulator.
The U.K. was the first in the West to roll out the vaccine from the University of Oxford and AstraZeneca PLC. Between Jan. 4 and Jan. 24, some 1.5 million people had that shot, and 6,014 people or 0.4% have reported side effects.
Thirteen people had a severe allergic reaction following the AstraZeneca shot.
Some 34 people were reported to the regulator to have died in the days and weeks following that injection, again mostly elderly people or people with other illnesses, and the deaths aren’t thought to be linked to the vaccine.