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NIH launches study of allergic reactions to COVID-19 vaccines

By Chris Newmarker | April 7, 2021

COVID-19 vaccines NIH

[Image by Sam Moqadam on Unsplash]

The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.

Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

Most of the rare, severe allergic reactions to the vaccines took place among people with a history of allergies — many of them with prior experience of having a life-threatening allergic reaction called anaphylaxis. Researchers are still uncertain why there are rare cases of anaphylactic reactions after the Moderna or Pfizer-BioNTech COVID-19 vaccines. Both do not contain common allergens such as eggs, latex, gelatin or preservatives.

The NIH’s National Institute of Allergy and Infectious Diseases is sponsoring and funding the news study, which is enrolling 3,400 adults ages 18 to 69 years at up to 35 academic allergy-research centers nationwide.

“The public understandably has been concerned about reports of rare, severe allergic reactions to the Moderna and Pfizer-BioNTech COVID-19 vaccines,” NIAID director Dr. Anthony S. Fauci said in a news release. “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.”

About 60% of study participants must have either a history of severe allergic reactions or a mast cell disorder diagnosis; the other 40% will not. Two-thirds of those in the study will be women because severe allergic reactions to the COVID-19 vaccines (and vaccines in general) have occurred mainly among women.

The study participants will randomly receive either a Pfizer-BioNTech vaccine, a Moderna vaccine or a placebo — with neither the participants nor the investigators initially knowing what is being administered. The investigators — allergists trained to recognize and treat anaphylaxis who will have proper emergency medications and equipment on hand — will observe each participant for at least 90 minutes after injection.

The NIH expects to have study results by the late summer.


Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: BioNTech, coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccines, Moderna, National Institute of Allergy and Infectious Diseases (NIAID), NIH, Pfizer
 

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

Comments

  1. shreveport2016 says

    April 7, 2021 at 5:23 pm

    I received the 1st Moderna vaccine injection on Friday, March 26, 2021. The following Tuesday evening or Wednesday morning I began to experience drowsiness and sometime Wednesday morning I was pretty disoriented, confused, and on Thursday I was unable to remember the events of the past 24 hours. I had text messages I sent cancelling work services for that Wednesday evening, but had I not had those texts, I would have had no recollection of the events of the previous day. I just learned that a friend just experienced the same kind of confusion and memory lapses. Is this one of the more serious side effects from the Moderna vaccine? I was diagnosed with Covid-19 on January 18, 2021 and was at home for about 5 weeks before I was symptom free and getting out of the house. I definitely will not be getting the second Moderna vaccine injection. Curious if any others have had similar experiences after receiving a Moderna Covid injection. Layne B.

  2. Jeneker says

    April 25, 2021 at 11:36 pm

    I had the first Moderna shot on March 25th, 2 days later started getting ringing in my left ear, would not go away. I made an appt with my ENT, no wax in the ear, he gave me some vitamins to take, they didn’t work. I have never had ringing in my ears, ever, and I attribute this to the Moderna vaccine. I also had strange blurring and prism type colors in the right eye(never had that before, then the next day left eye). This is all strange. So made an appt with my eye doctor, he could not find anything wrong, said I may have ocular migraines(which I have never had migraines ever). I wasn’t sure if I should get the second vaccine, but I did, on April 16th, and still the ringing in my ear persisted, stronger than before, wish I never got the vaccine. Plus in bed for 2 days with severe headache, aches and chills. Lost 6 pounds, too nauseated to eat. There should be some type of warning about these symptoms. Sucks.

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