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Israeli study: Pfizer shot safe for highly allergic patients, with supervision

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Of 429 people with serious allergies, only 9 had a reaction to the COVID shot, and all of them recovered quickly and experienced no further issues

By NATHAN JEFFAY

31 August 2021

People with serious allergies can safely be inoculated with the Pfizer coronavirus vaccine with supervision, an Israeli study has concluded.

Sheba Medical Center, Israel’s largest hospital, set up a special clinic to oversee administration of vaccines to highly allergic people, with medical assessments done first and doctors on hand to treat the patients in the case of any serious reactions.

The Pfizer-BioNTech vaccine by far is the shot most commonly used in Israel (Moderna has also been used but in a limited amount).

More than 8,000 people applied, and 429 with serious allergies were vaccinated under observation. Only nine of the 429 had allergic reactions, and all of them quickly recovered and were in good health through the study’s two-week follow-up period.

The team running the clinic wrote their findings in a peer-reviewed study in the Journal of the American Medical Association.

It concluded that, with the right expert oversight, “most patients with a history of allergic diseases and, particularly, highly allergic patients, can be safely immunized.”

Dr. Nancy Agmon-Levin, Sheba’s head of clinical immunology who directed the research, told The Times of Israel that allergic reactions were more common than with other vaccines, but that the level was not concerning and all reactions were easily managed.

She noted that initially there had been concerns about the Pfizer vaccine for highly allergic people, and that the US Food and Drug Administration had recommended that such people not be vaccinated. This has since been revised, and now few people are excluded on allergy grounds.

“Now, our data clearly shows that seriously allergic people can be vaccinated safely, which is important,” she said.

“This is significant for people with allergies, and also for others. Because if we’re seeing that even among the most allergenic people the vaccine is safe, we can infer that it’s very safe in terms of allergic reactions for the rest of the population that doesn’t suffer badly from allergies.”

The authors suggested that their research is particularly significant as clinical trials for the Pfzer vaccine and several subsequent studies had excluded patients with a history of allergic reactions, and there is confusion about the impact of vaccines on highly allergic people.

The study describes how careful assessment of patients with allergies allowed them to be safely given vaccines. They were invited to apply to Sheba, and 8,102 people submitted their details. Some 6,883 were defined as low-risk and were vaccinated in normal settings.

The next level of screening involved an allergy questionnaire, after which 785 received regular vaccination and five were deferred from immunization. The remaining 429 were deemed in need of care from the high-risk clinic, with vaccines given under observation.

Nine had allergic reactions, all of them women. Six of them had mild immediate allergic reactions, like swelling of the tongue or a cough that was fixed with antihistamine.

Three patients had anaphylactic reactions that included shortness of breath. Two of those three had a prior diagnosis of multiple drug allergies. All three were successfully treated with adrenaline, antihistamines, and an inhaler.

The study stated: “All nine patients who experienced an immediate reaction to the first dose were followed up by our team within two weeks; none reported recurrent or ongoing allergic symptoms.”

SOURCE: timesofisrael.com/israeli-s...

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