Infectious Disease

ACAAI publishes pointers on Pfizer’s COVID-19 vaccine in sufferers with allergic reactions

17th December 2020

3 min read

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Healio interview

Disclosure:
Patel does not report any relevant financial information.

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The American College of Allergy, Asthma and Immunology’s COVID-19 Task Force published guidelines on the risk of allergic reactions from the Pfizer-BioNTech COVID-19 vaccine.

Just before the FDA finalized an emergency approval for the vaccine last week, UK health officials advised against giving it to patients with a history of allergic reactions after two health care workers who received the vaccine experienced allergic symptoms.

In the guidelines, the American College of Allergy, Asthma, and Immunology (ACAAI) recommended discussing the benefits versus the risks in patients with common allergies and recommended not to vaccinate patients with a history of severe allergies to polyethylene glycol.

The ACAAI also recommended that the vaccine be given in settings where anaphylaxis can be treated and that patients be monitored for side effects after the injection.

Healio Primary Care spoke with Niraj Patel, MD, ACAAI COVID-19 Task Force Chair and Professor of Pediatric Infectious Diseases and Immunology at Levine Children’s Hospital in Charlotte, NC to learn more about the guidelines.

Q: Why is this guide needed?

A: Allergic reactions to vaccines are generally rare. The incidence of anaphylaxis is estimated to be 1.31 in 1 million administered doses. With the FDA approving the Pfizer-BioNTech emergency COVID-19 vaccine on December 11th, it is important that guidelines are available to clinicians and other providers regarding the risk of an allergic reaction with vaccination. The recommendations are based on the best knowledge available to date, but are subject to change with new information and additional guidance from the FDA or the CDC.

Q: What should GPs tell patients with frequent food and drug allergies and those with compromised immune systems about the vaccine?

People with frequent allergies to medicines, food, inhalants, and insects are no more likely to be allergic to the Pfizer-BioNTech COVID-19 vaccine than the general public. These patients should be informed about the benefits of the vaccine versus its risks. The Pfizer-BioNTech COVID-19 vaccine is not a live vaccine and can be given to immunocompromised patients.

Doctors and other providers should inform such immunocompromised patients about the possibility of a decreased immune response to the vaccine.

Q: How should doctors monitor for anaphylaxis after vaccination?

A: The Pfizer-BioNTech COVID-19 vaccine should be given in healthcare settings where anaphylaxis can be treated. All people must be observed for at least 20 to 30 minutes after the injection to determine any side effects. All anaphylactic reactions should be treated immediately with IM adrenaline as initial treatment.

Q: Which patients should not receive the Pfizer-BioNTech COVID-19 vaccine because of concerns about an allergic reaction?

A: The Pfizer-BioNTech COVID-19 vaccine should not be given to anyone with a known history of allergic reaction to polyethylene glycol as it is part of this vaccine, which is known to cause anaphylaxis. Data on the risk in people with a history of allergic reactions to previous vaccinations and / or mast cell activation syndrome / idiopathic anaphylaxis are very limited and are evolving. A clinical decision to administer the Pfizer-BioNTech COVID-19 vaccine should be made by the physician or other vaccine supplier, using their professional judgment and in consultation with the patient, in order to assess the benefits and risks associated with taking the vaccine to weigh up.

Q: Are mRNA vaccines more likely to induce allergic reactions than other vaccines?

A: It does not currently appear that mRNA vaccines are more likely to cause allergic reactions compared to other vaccines. In the Pfizer-BioNTech COVID-19 vaccine clinical trial, no allergic reactions or serious adverse events were reported in over 40,000 participants.

Q: The UK health authorities have advised against giving Pfizer BioNTech vaccine to patients with a history of allergic reactions. Should the US authorities do the same? Why or why not?

There is limited information on the two subjects in the UK who were allergic to the vaccine. It is likely that there were subjects in the Pfizer-BioNTech COVID-19 vaccine study who had frequent allergies to foods or drugs that tolerated the vaccine, although it is not clear whether this data has been collected or will be available. The Pfizer-BioNTech COVID-19 vaccine should not be given to anyone who has a history of allergic reaction to any of the vaccine components, particularly polyethylene glycol, as it is known to cause anaphylaxis. Again, it is no more likely than the public is that people with frequent allergies to drugs, food, inhalants, and insects will be allergic to the Pfizer-BioNTech COVID-19 vaccine. These patients should be informed about the benefits of the vaccine versus its risks.

References:

ACAAI. The American College of Allergy, Asthma, and Immunology publishes guidelines on the risk of allergic reactions to the Pfizer-BioNTech COVID-19 vaccine. https://acaai.org/news/american-college-allergy-asthma-and-immunology-releases-guidance-risk-allergic-reactions-pfizer. Accessed December 16, 2020.

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