Story at a glance

  • In rare instances, there have been reports of people experiencing allergic reactions, including serious episodes known as anaphylaxis, after being vaccinated.
  • The study is aiming to assess the proportion of participants who have a systemic allergic reaction within 90 minutes after receiving the Pfizer or Moderna vaccine.
  • The NIH said the study will include 3,400 adults ages 18-69 at up to 35 academic allergy research centers across the country.

The National Institutes of Health (NIH) announced Wednesday it has kicked off a study to determine the risk of allergic reactions to the Pfizer-BioNTech and Moderna COVID-19 vaccines. 

The health agency said a phase 2 clinical trial is underway to determine if people who are highly allergic or have a mast cell disorder are at increased risk for a systemic allergic reaction to any of the two-dose vaccines. In rare instances, there have been reports of people experiencing allergic reactions, including serious episodes known as anaphylaxis, after being vaccinated. 


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The Centers for Disease Control and Prevention (CDC) in January said allergic reactions occurred at a rate of 11.1 cases per million doses, with the majority occurring within 15 minutes of vaccination.  

“The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a statement

“The information gathered during this trial will help doctors advise 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 COVID-19 vaccination far outweigh the risks,” he said. 

The NIH said the study will include 3,400 adults ages 18 to 69 at up to 35 academic allergy research centers across the country. Approximately 60 percent of study participants must have either a history of severe allergic reactions or a diagnosis of a mast cell disorder, while 40 percent will not. 

About two-thirds of participants in each group will be women, as severe allergic reactions to vaccines have occurred mostly in females. 

The study is aiming to assess the proportion of participants who have a systemic allergic reaction within 90 minutes after receiving the Pfizer or Moderna vaccine. The NIH is expected to report data this summer. 


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Published on Apr 07, 2021