LONDON – The UK drug regulator has published its first real-world safety data from the two Covid-19 vaccines launched across the country to more than 10 million people, including 90% of those over 80. did not see unexpected side effects of the injections and that the benefits of vaccination far outweigh the risks.
The United Kingdom was the first country to authorize the injection of Pfizer Inc.-BioNTech SE for emergency use and had two cases of serious adverse reaction after the injection on the first day of its implementation on December 8. Both people recovered.
Between December 9 and January 24, about 5.4 million people in the UK received the injection from Pfizer and 16,756, or 0.3%, reported some type of adverse reaction after the injection. Adverse reaction notifications are made through the yellow card system, similar to the Vaccine Adverse Effects Notification System in the USA
The vast majority were mild symptoms associated with the injection, such as sore arms or low fever, the regulator said. About 101 people reported severe allergic reactions after the injection, or less than one in 10,000 cases, which occurred at a rate between 1 and 2 cases per 100,000 doses administered.
Similar findings for the Pfizer injection have been published in the United States, the British regulator said.
The United Kingdom prioritized the elderly population and healthcare professionals in its implementation of the vaccination and had 107 deaths after an injection of Pfizer reported to the medical regulator, none of which it believes is linked to the vaccine.
Most of these reports were in the elderly or people with underlying diseases.
“Old age and underlying chronic illnesses make coincident adverse events more likely, especially due to the millions of people vaccinated,” said the regulator in his report.
It does not monitor how many died of Covid-19 after vaccination, but other studies are investigating these cases, said Dr. Philip Bryan, head of vaccine safety at the drug regulator.
The United Kingdom was the first in the West to launch the vaccine from the University of Oxford and AstraZeneca PLC. Between January 4 and 24, about 1.5 million people received that injection, and 6,014 people, or 0.4%, reported side effects.
Thirteen people had a severe allergic reaction after the injection of AstraZeneca.
The regulator reported that 34 people died in the days and weeks after that injection, again, mostly elderly or people with other illnesses, and the deaths are not related to the vaccine.