ACAAI releases guidance related to risk of allergic reactions to Pfizer-BioNTech COVID-19 vaccine

With the emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine by the FDA on December 11, 2020, and distribution beginning today, the American College of Allergy, Asthma and Immunology COVID-19 Vaccine Task Force recommends the following guidance related to risk of an allergic reaction on vaccination for those who receive the vaccine. These recommendations are based on best knowledge to date but could change at any time, pending new information and further guidance from the FDA or CDC.

  1. Allergic reactions to vaccines, in general, are rare with the incidence of anaphylaxis estimated at 1.31 in 1 million doses given.
  2. Individuals with common allergies to medications, foods, inhalants, insects, and latex are no more likely than the general public to have an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine. Those patients should be informed of the benefits of the vaccine versus its risks.
  3. The Pfizer-BioNTech COVID-19 vaccine should be administered in a health care setting where anaphylaxis can be treated. All individuals must be observed for at least 20-30 minutes after injection to monitor for any adverse reaction. All anaphylactic reactions should be managed immediately, with epinephrine as the first line treatment.
  4. The Pfizer-BioNTech COVID-19 vaccine should not be administered to individuals with a known history of a severe allergic reaction to polyethylene glycol as it is a component of this vaccine that is known to cause anaphylaxis.
  5. Data related to risk in individuals with a history of allergic reactions to previous vaccinations and/or mast cell activation syndrome/idiopathic anaphylaxis is very limited and evolving. A decision to receive the Pfizer-BioNTech COVID-19 vaccine should be undertaken by you with your physician or other provider administering the vaccine using their professional judgment balancing the benefits and risks associated with taking the vaccine.
  6. The Pfizer-BioNTech COVID-19 vaccine is not a live vaccine and it can be administered to immunocompromised patients. Physicians and other providers should inform such immunocompromised patients of the possibility of a diminished immune response to the vaccine. We do not know at this time if people with a weakened immune system will respond to the vaccine and be protected from COVID-19.
  7. If you have questions related to the risk of an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine, contact your local board-certified allergist/immunologist.

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