Unvaccinated children ages 5-17 are being enrolled in a Vanderbilt University Medical Center study to determine risk and mechanisms of allergic reactions to COVID-19 Pfizer-BioNTech mRNA vaccine.
Elizabeth Phillips, MD, the principal investigator of the double-blind randomized controlled study, recently led the adult-focused portion of the trial to help determine the proportion of those who experience a systemic allergic reaction to either of the two doses of the COVID-19 mRNA vaccines made by Pfizer-BioNTech and Moderna.
The current trial, an extension of the adult version, will follow the same study design to examine how the Pfizer vaccine impacts children who are highly allergic to certain foods, pharmaceuticals, previous routine vaccines, other environmental triggers and/or who have had at least one episode of anaphylaxis requiring an epinephrine injection.
“It’s important to study children too,” said Phillips, professor of Medicine and Pharmacology and the John A. Oates Chair in Clinical Research at VUMC. “The vaccines have proven to be overwhelmingly safe in both adults and children, but we cannot assume that highly allergic children will react like highly allergic adults to vaccines. By adulthood most have grown out of common food allergies such as milk and egg. In addition, more boys than girls are affected by many types of allergies in childhood whereas this ratio is reversed after adolescence.
“We are looking for children who have not had the vaccine yet,” said Phillips. “There are some folks who have a hesitancy to vaccinations when their child has presented with a reaction in the past. Many parents may be avoiding or holding off having their children vaccinated until more information is available.”
Phillips stressed that the trial is a safe place for this subset of children to receive their COVID vaccination.
“The biggest draw for many parents will be that their children will be closely monitored and observed by qualified people at a children’s hospital. That level of care provides some comfort to families.”
Phillips said that the SARS-CoV-2 mRNA vaccines could be among the safest vaccines ever developed, and now over a year since the start of the vaccine rollout, true allergies associated with vaccine have proven to be very rare.
VUMC is one of 29 sites participating in the trial, which is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Phillips and her colleagues are seeking about 20 volunteers for the study. Participants with no history of severe allergic reactions are also needed.
Study participants will be randomized into two groups, randomized 2:1 to initially receive the Pfizer-BioNTech COVID-19 mRNA vaccine versus a placebo vaccine dose of normal saline. All children will be observed for at least 1.5 hours during every visit. The group who received the placebo will be eligible to receive the Pfizer-BioNTech COVID-19 mRNA vaccine four days later, and both groups will receive the vaccine three weeks apart per the standard administration. Blood and urine samples will be taken from participants as part of the study to determine responses and mechanisms of reactions to the vaccines.
There are several ways to obtain information about the study and complete a prescreening survey:
- Email at email@example.com
- Call 615-831-4277
- Follow this link: https://redcap.vanderbilt.edu/surveys/?s=44T3P7J8PM4XTXFJ.