UK: Two people report allergic reaction to COVID-19 vaccine
LONDON — United Kingdom regulators say people who have a “significant history” of allergic reactions shouldn’t receive the new Pfizer-BioNTech vaccine while they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination programme.
The national medical director for the National Health Service in England says health authorities were acting on a recommendation from the Medical and Healthcare Products Regulatory Agency.
Professor Stephen Powis says the agency has advised, on a precautionary basis, that “people with a significant history of allergic reactions do not receive this vaccination.”
He says both people are recovering well.
Authorities have not specified what their reactions were.
The medical regulatory agency also said vaccinations should not be carried out in facilities that don’t have resuscitation equipment.
Pfizer and BioNTech said they were working with investigators “to better understand each case and its causes.″
Late-stage trials of the vaccine found “no serious safety concerns,” the companies said.
More than 42,000 people have received two doses of the shot during those trials.
“In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee,” the companies said.
Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who weren’t previously known to have severe allergies.
Even in non-emergency situations, health authorities must closely monitor new vaccines and medications because studies in tens of thousands of people can’t detect a rare risk that would affect one in one million.
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