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Allergist Review: Severe Allergies Usually Won’t Preclude COVID-19 Vaccination

Patients with a history of severe allergies are understandably nervous about receiving the COVID-19 vaccines, which a few cases of anaphylaxis reported. But which of those should actually avoid getting vaccinated? A new review by allergists helps provide some answers useful to pharmacists. Find out who should not be immunized, and which patients should be monitored after receiving their shot.

BOSTON – If they are not already, pharmacists will be fielding a lot of questions about the safety of the COVID-19 vaccines in patients with histories of severe allergies.

Those concerns are fueled by reports of possible allergic reactions to the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, both recently approved for emergency use by the Food and Drug Administration (FDA).

To help provide guidance, Massachusetts General Hospital-led experts examined all relevant information to offer reassurance that the vaccines can be administered safely even to people with food or medication allergies. The article is published in the Journal of Allergy and Clinical Immunology: In Practice.

The report points out that the FDA Emergency Use Authorization guidance for both vaccines is to not administer the vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the COVID-19 vaccine. In addition, the national Centers for Diseases Control and Prevention (CDC) advises that all patients should be observed for at least 15 minutes after COVID-19 vaccination (30 if there are specific concerns) and that pharmacy staff must be able to identify and manage anaphylaxis.

“Post-FDA approval, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern,” the authors write. “To provide reassurance and support during widespread vaccination across America, allergists must offer clear guidance to patients based on the best information available, but also in accordance with the broader recommendations of our US regulatory agencies.”

The review proposes risk stratification schemes for both patients with different allergy histories to safely receive their first COVID-19 vaccine and for recipients who develop a reaction to their first dose of COVID-19 vaccine.

After the UK’s medical regulatory agency advised that individuals with a history of anaphylaxis to a medicine or food should avoid COVID-19 vaccination, the FDA reviewed the evidence and came up with different advice. It said vaccines only should be from patients with a history of severe allergic reactions to any component of the COVID-19 vaccine. The authors emphasize that U.S. agencies do not recommend that patients with food or medication allergies avoid vaccination.

To provide insights from allergists' perspectives, Aleena Banerji, MD, clinical director of the Allergy and Clinical Immunology Unit at MGH and associate professor at Harvard Medical School, and her colleagues have summarized what's currently known about allergic reactions to vaccines like those developed against COVID-19, and they have proposed detailed advice so that individuals with different allergy histories can safely receive their first COVID-19 vaccine. They also outline steps on safely receiving the second dose in individuals who develop a reaction to their first dose of COVID-19 vaccine.

"As allergists, we want to encourage vaccination by reassuring the public that both FDA-approved COVID-19 vaccines are safe,” explained lead author Aleena Banerji, MD, clinical director of the Allergy and Clinical Immunology Unit at MGH and associate professor at Harvard Medical School, “Our guidelines are built upon the recommendations of U.S. regulatory agencies and provide clear steps to the medical community on how to safely administer both doses of the vaccine in individuals with allergic histories.”

Noting that allergic reactions to vaccines are rare, with a rate of about 1.3 per 1 million people, they recommend that patients with a history of anaphylaxis to an injectable drug or vaccine containing polyethylene glycol or polysorbate consult with an allergist before getting the vaccine. On the other hand, they emphasize that patients with severe allergies to foods, oral drugs, latex, or venom can safely receive the COVID-19 vaccines.