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NIH Researches Rare Allergic Reactions To COVID Vaccines

By Steven Reinberg
HealthDay reporter

THURSDAY April 8, 2021 (HealthDay News) – A new clinical trial will examine whether people who are highly allergic or have what is called a mast cell disorder are at higher risk of a sudden allergic reaction to Moderna or Pfizer COVID-19 vaccines.

“The public has understandably been concerned about reports of rare and serious allergic reactions to Moderna and Pfizer-BioNTech COVID-19 vaccines,” said Dr.Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID ).

“The information gathered during this trial will help doctors educate people who are highly allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines. However, for most people, the benefits of the vaccine. COVID-19 vaccinations far outweigh the risks, ”Fauci said in a press release from NIAID.

A systemic allergic reaction to a vaccine occurs in one or more parts of the body far from the injection site.

A mast cell disorder is caused by an abnormal, overactive type of white blood cell, or both. This exposes a person to life-threatening reactions that resemble allergic reactions.


Researchers will also look at the biological mechanism behind the reactions and whether there is a way to predict who is most at risk.

Moderna and Pfizer COVID-19 vaccines have been administered to millions of Americans. Most serious and rare reactions have occurred in people with a history of allergies. A number of them had previously had a life-threatening allergic reaction called anaphylaxis, the researchers noted.

The new study will recruit 3,400 people aged 18 to 69. According to the NIAID, up to 35 allergy research centers across the United States will participate.

By design, about 60% of study participants must have a history of severe allergic reactions or have been diagnosed with a mast cell disorder. The rest will not be.

Participants will be randomly assigned to receive either the Pfizer or Moderna vaccine or a placebo followed by either vaccine.

About two-thirds of the participants will be women, as serious allergic reactions to the vaccines – and in particular to the Moderna and Pfizer COVID-19 vaccines – have occurred in women, the researchers said.


Investigators will look at how many participants in each group have a systemic allergic reaction within 90 minutes of the injection.

The results are expected at the end of the summer.

More information

To learn more about the safety of the COVID-19 vaccine, visit the U.S. Centers for Disease Control and Prevention.

SOURCE: U.S. National Institute of Allergy and Infectious Diseases, press release, April 7, 2021


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