ARLINGTON HEIGHTS (January 7, 2021) – The American College of Allergy, Asthma and Immunology (ACAAI) COVID-19 Vaccine Task Force is closely monitoring information from sources reporting on allergic reactions to the mRNA COVID-19 vaccines. As such, ACAAI has updated its guidance to reflect the most recent recommendations from the CDC and the FDA. Of note, the Task Force, along with the CDC, recommends certain questions regarding past vaccine reactions be asked of everyone receiving a vaccine.
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 Dec. 11, 2020, and the Moderna vaccine on Dec. 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. Anyone receiving the vaccine should be screened to determine possible risk of an allergic reaction to the mRNA COVID-19 vaccines and asked the following questions:
- Do you have a history of a severe allergic reaction to an injectable medication (intravenous, intramuscular, or subcutaneous)?
- Do you have a history of a severe allergic reaction to a prior vaccine?
- Do you have a history of a severe allergic reaction to polyethylene glycol (PEG), a polysorbate or polyoxyl 35 castor oil (e.g., paclitaxel) containing injectable or vaccine?
If yes to any of these answers, you should be referred to a board-certified allergist/immunologist for further evaluation prior to COVID-19 vaccination.
2. 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. The majority of anaphylactic reactions have occurred within 15 minutes.
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 (PEG) is one of the ingredients and has been known to cause anaphylaxis. Since polysorbate, a substance found in medications and foods, can cross-react with PEG, patients with allergic reactions to polysorbate should not be immunized with the mRNA vaccines.
4. 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, patients who experience a severe allergic reaction, or who have questions related to risk of an allergic reaction, may be referred to a local board-certified allergist/immunologist to provide more care or advice.
5. The ACAAI does not currently endorse any testing protocol for PEG, polysorbate, or the mRNA COVID vaccines because we do not yet know the safety and predictive values of these tests.
6. Data regarding risk in individuals with a history of allergic reactions related to 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.
7. People with common allergies to medications, foods, inhalants, insects, and latex are probably 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.
8. 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.
9. If you are receiving the mRNA COVID vaccine, you should expect local (e.g., pain, swelling, skin rash at the injection site, some swelling of the lymph nodes on the same side as the vaccinated arm) and systemic (e.g., fever, fatigue, headache, chills, muscle pain, joint pain, or inflammation) post-vaccination symptoms. Depending on vaccine product (Pfizer or Moderna), age group, and vaccine dose, approximately 80–89% of vaccinated persons develop at least one local symptom and 55–83% develop at least one systemic symptom following vaccination.
Editor’s note: Please contact Hollis Heavenrich-Jones hollisheavenrich-jones@acaai.org 847-725-2277 if you would like to interview a member of the ACAAI COVID-19 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
Banerji A, Wickner PG, Saff R, Stone CA Jr, Robinson LB, Long AA, Wolfson AR, Williams P, Khan DA, Phillips E, Blumenthal KG, mRNA Vaccines to Prevent COVID-19 Disease and Reported Allergic Reactions: Current Evidence and Approach, The Journal of Allergy and Clinical Immunology: In Practice (2021)
CDC 12/30/2020: Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States
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.
