The National Institutes of Health announced Wednesday that it has begun a clinical trial to determine the risk of allergic reactions to Moderna’s and Pfizer’s COVID-19 vaccines.
Investigators will look into whether allergic reactions are more frequent in people who are “highly allergic or have a mast cell disorder” than in people who do not have allergies, according to a news release from NIH.
The study will also investigate the “biological mechanism” behind systemic allergic reactions to better understand what factors put someone at more risk.
“The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” Dr. 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.”
The study will be made up of 3,400 adults who will be divided into groups and receive the Pfizer-BioNTech vaccine, the Moderna vaccine or a placebo followed by one of the two vaccines.
Additionally, 60 percent of participants must have a history of severe allergic reactions or a mast cell disorder diagnosis.
The study’s results are expected to be released toward the end of summer.
The U.S. Centers for Disease Control and Prevention said that having a severe allergic reaction, such as anaphylaxis, after receiving the COVID-19 vaccination is rare.
Health care providers have been instructed to monitor patients for 15 minutes after they receive the jab. Patients with a history of allergic reactions should be watched for 30 minutes.
Alkis Togias, chief of NIAID’s Allergy, Asthma and Airway Biology Branch, said the agency became interested in allergic reactions after reactions were categorized as anaphylaxis.
“We are a little bit concerned that people who have had a lot of allergies who have had reactions like this to all kinds of things, not just vaccines, may be afraid to get vaccinated now,” Togias told CNBC in December.
“We just don’t want that to happen. We want to find a way for them to get vaccinated,”
Former President Donald Trump’s coronavirus vaccine czar, Noncef Slaoui, mentioned the upcoming study while it was in its planning stages in December.
“There is now advanced planning for a study in highly allergic individuals in clinical trials to test the Moderna and Pfizer vaccines and try to understand the immune mechanisms that are underpinning any reactions,” he said.
Pfizer and Moderna’s vaccines have been authorized for emergency use but have not been approved by the Food and Drug Administration.
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