Phase 2 Trial is Enrolling Participants to Assess the True Prevalence of Allergic Reactions to COVID-19 Vaccines

A new study, funded by the NIH and conducted by Vanderbilt University Medical Center (VUMC), is working to assess allergic reactions to COVID-19 vaccines. The trial will include individuals between the ages of 12-69 and is currently enrolling participants. The vaccines assessed in this particular trial are Pfizer and Moderna.

The principal investigator of this trial is Elizabeth Philips who specializes in drug hypersensitivity.

The Prevalence of Allergic Reactions

This trial is a Phase 2 investigation which will occur across 30 trial sites in effort to understand just how prevalent allergic reactions to the mRNA vaccines are.

As of now, it looks like 3-4 cases of extreme allergic reactions occur in every million doses.

The researchers explain the necessity of reassuring the public about the safety of these vaccines in order to increase vaccination rates. The concern if we don’t reach a high vaccination rate is a virus which continues to mutate.

Although safety concerns by the public are completely valid, if studies like this can reduce some hesitancy regarding the vaccine, it could lead to a reassured public, and ultimately a greater percentage vaccinated.

Who Can Participate

There will be about 120 participants in this trial. The researchers are looking for willing participants who fit the following criteria:

  1. Healthy individuals at least 18 years of age who have not received the vaccine (but would like to) and have never has a severe allergic reaction.
  2. Individuals who have a history of severe allergic reactions to environmental triggers, food, or drugs. These individuals must have had a minimum of one anaphylactic episode which required them to use an epipen in the last 5 years.

All participants will be randomly assigned to either receive one of the vaccines or the placebo. All participants will eventually receive the vaccine by the end of the trial.

A prescreen is required to make sure individuals do fit the criteria for the study. If you are interested, you can sign up here or on the VUMC website.

You can read full details on this new trial and its purpose here.

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