The National Institutes of Health (NIH) has launched a clinical trial to better understand allergic reactions associated with the Moderna and Pfizer-BioNTech COVID-19 vaccines. The trial, involving 3,400 adults, 60% of whom have a history of severe allergic reactions or a diagnosis of mast cell disorder, will also consider the biological mechanism behind the reactions to see if a genetic pattern or other factors can better predict who runs a risk of reaction.
The participants will be divided into two groups and will not know if they are receiving a vaccine or placebo until the second dose has been administered and the observation period has been completed.
The Centers for Disease Control & Prevention (CDC) first reported cases of anaphylaxis after the initial introduction of the COVID-19 vaccines. In rare cases, some recipients experienced adverse reactions, such as severe allergic reactions, within minutes of administering the vaccine. As such, the agency has issued guidelines recommending that those experiencing anaphylaxis after the first dose not receive the second dose, and that vaccine providers should be equipped with epinephrine, antihistamines, blood pressure monitors and time devices to check a patient’s pulse. .
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“The public is 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 National Institute of Allergy and Infectious Diseases (NIAID), in a news release. “The information gathered during this trial will help physicians advise people who are very allergic or have a mast cell disorder about the risks and benefits of receiving these two vaccines. For most people, the benefits of COVID are However, a 19-year vaccination outweighs the risks. “
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In the trial, researchers will collect blood, urine and nasal swabs from the participants before the jab, followed by blood and urine. Participants will also be monitored for at least 90 minutes after each injection. Researchers will analyze the proportion of study participants in each group who experience a systemic allergic reaction within 90 minutes after any dose.
“If a significant number of systemic allergic reactions to one or both vaccines occur during the trial, investigators will analyze these biological samples to investigate possible mechanisms for the reactions and whether certain genetic patterns are associated with a higher risk,” the news release said. .
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The researchers expect to have results by late summer.