American College of Allergy, Asthma, and Immunology Updates Guidance on Risk of Allergic Reactions to mRNA COVID-19 Vaccines

ARLINGTON HEIGHTS (Dec. 22, 2020) – Following reports of some patients experiencing anaphylaxis after getting a COVID-19 vaccine, the CDC has issued guidance related to COVID-19 vaccines and severe allergic reactions. Specifically, the CDC recommends patients experiencing a severe allergic reaction after getting the first shot should not get the second shot. The CDC also says that doctors may refer these patients to a specialist in allergies and immunology to provide more care or advice.

Reactions to vaccines, in general, are rare, with the incidence of anaphylaxis estimated at 1.31 in 1 million doses given. With the FDA emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020 and the Moderna vaccine on December 18, 2020, the ACAAI COVID-19 Vaccine Task Force recommends the following guidance for physicians and other providers related to risk of an allergic reaction on vaccination.

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. The mRNA COVID-19 vaccines should be administered in a health care setting where anaphylaxis can be treated. All individuals must be observed for at least 15-30 minutes after injection to monitor for any adverse reaction. All anaphylactic reactions should be managed immediately with epinephrine as the first line treatment.
2. The CDC has issued guidance on COVID-19 vaccines and severe allergic reactions. According to the CDC, if you have a severe allergic reaction after getting the first shot, you should not get the second shot. Additionally, the CDC notes patients who experience a severe allergic reaction may be referred by their doctor to a specialist in allergies and immunology to provide more care or advice.
3. The mRNA COVID-19 vaccines should not be administered to individuals with a known history of a severe allergic reaction to any component of the vaccine. Although the specific vaccine component causing the anaphylaxis has not been identified, polyethylene glycol is one of its ingredients and has been known to cause anaphylaxis.
4. 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 either of the mRNA COVID-19 vaccines 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.
5. People 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 mRNA COVID-19 vaccines. Those patients should be informed of the benefits of the vaccine versus its risks.
6. The mRNA COVID-19 vaccines are not live vaccines and 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 vaccines.
7. If you have questions related to the risk of an allergic reaction to either of the mRNA COVID-19 vaccines, contact your local board-certified allergist/immunologist.

Editor’s note: Please contact Hollis Heavenrich-Jones [email protected] 847-725-2277 if you would like to interview a member of the ACAAI Covid Task Force on the topic of allergic reactions to the vaccines.

About ACAAI The ACAAI is a professional medical organization of more than 6,000 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. The College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit AllergyandAsthmaRelief.org. Join us on Facebook, Pinterest and Twitter.

References

McNeil MM, Weintraub ES, Duffy J, et al. Risk of anaphylaxis after vaccination in children and adults. J Allergy Clin Immunol. 2016; 137(3):868-878.

Dreskin et al. International Consensus (ICON): allergic reactions to vaccines. World Allergy Organization Journal 2016; 9:32.

Wylon, K., Dölle, S. & Worm, M. Polyethylene glycol as a cause of anaphylaxis. J Allergy Asthma Clin Immunol. 12, 67 (2016).

Stone CA, Liu Y, et al. Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized.  J Allergy Clin Immunol Pract. 2019; 7(5): 1533–1540.

Sellaturay P, et al. Polyethylene Glycol–Induced Systemic Allergic Reactions (Anaphylaxis), J Allergy Clin Immunol Pract. 2020.