Thursday, April 8, 2021 (HealthDay News)-new Clinical Trials Will investigate whether people with high allergies or mast cell disease are suddenly at higher risk Allergic reaction To Moderna or Pfizer COVID-19 vaccine.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said: “Understandably, the public is concerned about reports of rare and severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines. ”
“The information collected in this trial will help doctors advise people with high allergies or mast cell disease about the risks and benefits of the two vaccines. However, for most people, the benefits of COVID-19 vaccination far outweigh the benefits. Risk”, Fauci said in a NIAID press release.
A systemic allergic reaction to the vaccine occurs in one or more parts of the body far away from the injection site.
Mast cell disease is caused by an abnormal, overactive white blood cell, or both. It puts a person at risk of life-threatening reactions that look like allergic reactions.
Researchers will also study the biological mechanisms that cause the response, and whether there are ways to predict who is most at risk.
Moderna and Pfizer COVID-19 vaccines have been provided to millions of Americans. Most rare, serious reactions occur in people with a history of allergies.Many of them have had life-threatening allergic reactions before, called Allergic reactionThe researchers pointed out.
The new study will recruit 3,400 people, between the ages of 18 and 69. NIAID said that as many as 35 allergy research centers across the United States will participate.
By design, approximately 60% of study participants must have a history of severe allergic reactions or have been diagnosed with mast cell disease. The rest will not.
Participants will be randomly assigned to receive Pfizer or Moderna injections, or receive Placebo The second is two vaccines.
Researchers say that about two-thirds of the participants will be women, because severe allergic reactions to vaccines, especially Moderna and Pfizer COVID-19 vaccines, occur in women.
Researchers will study how many participants in each group experience systemic allergic reactions within 90 minutes after the injection.
The result is expected to be at the end of this summer.
To learn more about the safety of the COVID-19 vaccine, please visit U.S. Centers for Disease Control and Prevention.
Source: National Institute of Allergy and Infectious Diseases, press release, April 7, 2021