The National Institutes of Health (NIH) has launched a clinical trial to better understand allergic reactions related to Moderna and Pfizer-BioNTech COVID-19 vaccines. The trial, which involves 3,400 adults, 60% of whom have had 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 is at risk for a reaction.
Participants will be divided into two groups and be unaware of whether they are receiving a vaccine or placebo before the second dose is administered and the observation period is over.
The Centers for Disease Control and Prevention (CDC) first reported cases of anaphylaxis weeks after the first roll-out of COVID-1
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“The public has understandably been 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 press 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-19 vaccination however, far greater than the risks. “
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In the experiment, researchers will collect blood, urine and nasal swabs from participants before jab and blood and urine after. 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 experienced a systemic allergic reaction within 90 minutes after each dose.
“If a significant number of systemic allergic reactions occur to one or both vaccines during the trial, investigators will analyze these biological samples to investigate possible mechanisms of the reactions and whether certain genetic patterns are associated with higher risk,” the press release said.
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The researchers expect to have results before late summer.