The American College of Allergy, Asthma, and Immunology (ACAAI) is issuing updated guidance on the risk of allergic reactions tied to mRNA Covid-19 vaccines.
The specter of allergic reactions tied to injections of the Pfizer-BioNTech and Moderna mRNA vaccines first cropped up on day one of the U.K.’s Covid-19 vaccination push, when two healthcare workers suffered anaphylactic reactions after receiving shots of the Pfizer vaccine. And, while reports of allergic reactions have remained rare, a recent report in New England Journal of Medicine found that such reactions are approximately 10 times higher than those reported for other established vaccines — while anaphylaxis typically occurs at a rate of 1 in 1 million vaccine doses, reactions have been occurring at a rate of roughly 1 in 100,000 in early Covid vaccine recipients.
ACAAI explained that it is updating its guidance “to reflect the most recent recommendations from the CDC and the FDA.” A centerpiece of the new guidance, the organization noted, involves questioning vaccine recipients regarding their history of reactions to vaccines.
The ACAAI issued the following 9 recommendations:
- “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.
- “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.
- “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.
- “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.
- “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.
- “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.
- “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.
- “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.
- “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.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 328
Topic ID: 80,328,730,933,31,926,328,99,192,927,925,934