THURSDAY, April 8, 2021 (HealthDay News) – A new clinical study is looking at whether people with high allergies or what is known as mast cell disorder are at higher risk of a sudden allergic reaction to Moderna or Pfizer COVID-19 vaccinations.
“The public was understandably concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” said Dr. Anthony Fauci, director of the United States National Institute for Allergies and Infectious Diseases (NIAID).
“The information gathered during this study will help doctors educate people with high allergies or mast cell disorder about the risks and benefits of receiving these two vaccines. For most people, however, the benefits of vaccinating against COVID-19 far outweigh the risks.” Fauci said in a NIAID press release.
A systemic allergic reaction to a vaccine occurs in one or more parts of the body outside the injection site.
Mast cell disorder is caused by a type of white blood cell that is abnormal, overly active, or both. It puts a person at risk for life threatening reactions that look like allergic reactions.
Researchers will also look at the biological mechanism that causes the reactions and whether there is any way to predict who is most at risk.
Moderna and Pfizer’s COVID-19 vaccines have been given to millions of Americans. Most of the rare, severe reactions have occurred in people with a history of allergies. Some of them had previously had a life-threatening allergic reaction called anaphylaxis, the researchers found.
3,400 people between the ages of 18 and 69 will take part in the new study. According to NIAID, up to 35 allergy research centers in the US will participate.
Due to the design, around 60% of the study participants must have had severe allergic reactions in the past or have been diagnosed with a mast cell disorder. The rest won’t.
Participants will randomly receive either the Pfizer or Moderna shot, or a placebo, followed by one of the two vaccines.
About two-thirds of the participants will be women, as women have had severe allergic reactions to vaccines – and especially to Moderna and Pfizer’s COVID-19 vaccines, the researchers said.
The researchers will study how many participants in each group have a systemic allergic reaction within 90 minutes of the injection.
The results are expected by the end of this summer.
More information
To learn more about COVID-19 vaccine safety, visit the U.S. Centers for Disease Control and Prevention.
SOURCE: US National Institute for Allergies and Infectious Diseases, news release, April 7, 2021
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