Toronto Star

U.K., firms investigat­e allergic reactions

Two people who received COVID-19 vaccine had history of significan­t allergies


LONDON— Britain’s medical regulator warned Wednesday that people with a history of serious allergic reactions shouldn’t get the COVID-19 vaccine from Pfizer and BioNTech, and investigat­ors looked into whether two reactions on the first day of the U.K.’s vaccinatio­n program were linked to the shot.

The advice was issued on a “precaution­ary basis,” and the people who had the reactions had recovered, said professor Stephen Powis, medical director for National Health Service in England.

Pfizer and BioNTech said they were working with investigat­ors “to better understand each case and its causes.”

Also on Wednesday, Canada’s health regulator approved the vaccine, with Dr. Supriya Sharma, chief medical adviser at Heath Canada, calling it “a momentous occasion.”

Canada is set to receive up to 249,000 doses this month and Canadian officials expect to start administer­ing them next week as soon after they are shipped from Belgium on Friday.

Britain’s Medical and Healthcare Products Regulatory Agency has said people should not receive the shot if they have had a significan­t allergic reaction to a vaccine, medicine or food, such as those who have been told to carry an adrenalin shot — such as an EpiPen or other similar devices — or others who have had potentiall­y fatal allergic reactions. The medical regulator also said vaccinatio­ns should be carried out only in facilities that have resuscitat­ion equipment.

Such advice isn’t uncommon; several vaccines already on the market carry warnings about allergic reactions, and doctors know to watch for them when people who’ve had reactions to drugs or vaccines in the past are given new products.

The two people who reported reactions were NHS staff members who had a history of significan­t allergies and carried adrenalin shots. Both had serious

reactions but recovered after treatment.

Stephen Evans, a professor of pharmacoep­idemiology at the London School of Hygiene & Tropical Medicine, said the regulator had done the right thing, but the general public shouldn’t be worried about getting the vaccine. “One has to remember that even things like Marmite can cause unexpected severe allergic reactions,” he said, referring to the food spread that is made from brewer’s yeast.

Dr. Ashish Jha, dean of the School of Public Health at Brown University, said he would advise patients who have had severe allergic reactions to other medicines or foods to delay vaccinatio­n if they can while the two cases in the U.K. are investigat­ed. He would extend that advice to people who carry EpiPens.

“The cautionary approach is to say to people who have had severe reactions to other things, ‘just hold,’ ” Jha said.

He added that because the vaccine is so high-profile, “every little thing that happens all the time is going to get magnified. We should talk about it, we should be honest with people, but we should put it into context and help people understand … there is a small proportion of people who have an allergic reaction to almost any medicine.”

The comments came a day after Britain rolled out its mass vaccinatio­n program amid efforts to control a pandemic

that has killed more than 62,000 people across the country. The MHRA gave an emergency authorizat­ion to the PfizerBioN­tech vaccine last week, making Britain the first country to approve its widespread use.

Even in nonemergen­cy 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. Authoritie­s have not said how many people have received the shot in Britain so far, but they plan to give 800,000 doses in the first phase, which will target people over 80, nursing home staff and some NHS workers.

Late-stage trials of the vaccine found “no serious safety concerns,” Pfizer and BioNTech said. More than 42,000 people have received two doses of the shot during those trials.

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.

As part of its emergency authorizat­ion for the vaccine, the MHRA required health care workers to report any adverse reactions to help regulators gather more informatio­n about safety and effectiven­ess.

 ?? VICTORIA JONES GETTY IMAGES ?? Sir Simon Stevens, chief executive of the NHS in the U.K., talks with a patient at a vaccinatio­n centre. Two people have had a severe reaction, but recovered.
VICTORIA JONES GETTY IMAGES Sir Simon Stevens, chief executive of the NHS in the U.K., talks with a patient at a vaccinatio­n centre. Two people have had a severe reaction, but recovered.

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