A U.S. health agency is looking for volunteers for a study of allergic reactions to the two COVID-19 vaccines built on messenger RNA (mRNA) technology, though several people who experienced reactions say interested people should not enroll.
The National Institute of Allergy and Infectious Diseases (NIAID), an office within the National Institutes of Health (NIH), started the trial last year but is having trouble enrolling enough people.
According to the trial’s official record, investigators started recruiting in July 2021 and the first patient received a vaccine on Sept. 8, 2021.
Participants must have experienced mild or moderate allergic reaction to the Pfizer or Moderna COVID-19 vaccines, both of which are based on the mRNA platform. During the study, each person will get a dose and be monitored for another reaction.
Only 13 people have volunteered so far, Dr. Pamela Guerrerio, the study’s principal investigator, told The Epoch Times in an email. All 13 have been vaccinated.
Guerrerio and Dr. Anthony Fauci, NIAID’s director, said in statements released by the agency that the study was aimed at better understanding allergic reactions to the vaccines and whether people who experience them could safely finish their two-shot primary regimen.
“Our study aims to provide a better understanding of the mechanisms responsible for systemic allergic reactions such as hives, swelling, trouble breathing and light-headedness or passing out,” Guerrerio said.
All participants are admitted for at least four days to an intensive care unit run by the government in Bethesda, Maryland. Officials say experienced medical staff will be on hand, along with equipment and medicine to treat severe allergic reactions.
Participants will randomly receive Pfizer’s vaccine or a placebo on one day. The following day, they will receive whichever one they had not received the previous day.
Investigators will test the breathing and blood of the volunteers and complete questionnaires prior to, at the time of, and in the months following vaccination. Participants are expected to return to Maryland one month and five months after vaccination. If participants experience no reaction or a mild reaction, they’ll be offered a booster shot during the latter visit.
The study is designed to enroll up to 100 patients but investigators “anticipate that they can fulfill their research objectives with fewer than 30 participants,” an NIAID spokesperson told The Epoch Times via email.
Investigators declined an interview request.
The NIAID is also running a study assessing whether people with a history of allergic reactions or mast cell disorder are at increased risk of an immediate allergic reaction to the Pfizer or Moderna shots. The study was expected to be completed by the end of March, but it is not finished yet, according to the agency.
About five cases of severe allergic reaction occur per million COVID-19 vaccine doses administered, according to federal data.
Dr. Elizabeth Phillips, a professor at the Vanderbilt Institute for Infection, Immunology and Inflammation who studies immune responses to drugs, said the new study would be important “to sort out the safety of individuals who have had an immediate systemic allergic reaction to dose #1 of an mRNA vaccine.”
Data so far indicate that people who had a reaction after receiving a dose of a vaccine can eventually get another dose safely, Phillips, who is not involved in the research, told The Epoch Times via email, adding, “Understanding mechanisms and pathways of these reactions will help us personalize care and make sure that each individual can be vaccinated as safely as possible.”
Several people who had a suspected or confirmed reaction, though, said they would not participate in the study.
“It’s a pretty risky trial for somebody, especially with no way to be refunded for any type of medical bills or any issues following the trial,” Skylar Bush, 35, told The Epoch Times.
Bush, an Oregon resident, was diagnosed with a severe allergic reaction to Moderna’s vaccine after receiving the jab in April 2021, according to medical records reviewed by The Epoch Times.
Participants in National Institutes of Health studies are typically paid, sometimes thousands of dollars. It wasn’t clear what the payment would be for participating in the allergic reaction trial. NIAID did not respond when asked if participants would be paid and if medical bills related to any reactions they experience during the trial would be covered.
“I would be super cautious. Anyone going into that trial, I would try to deter them from doing that,” Bush said. “I love that they’re trying to like investigate clinical trials and do science. I’m pro-science. But they’re doing it with the cart before the horse of the ability to protect these people signing up for the trials because everyone during the trials is going to sign a liability to not be able to sue” or get proper reimbursement for future issues.
Matthew Matlock, 38, of California, who experienced a suspected allergic reaction after getting vaccinated, says he doesn’t trust the government enough to enroll, pointing to how the NIH has not released information from its study of people with confirmed and suspected neurologic reactions to the vaccines.
“I haven’t seen anything really super encouraging from some of these organizations, like the NIH and the CDC, to do things that are unbiased and aren’t trying to necessarily prove the theory that not only are the vaccines effective, but they’re safe, and that seems to be the agenda across the board,” Matlock, of California, told The Epoch Times.
“Until I feel like we’re at a point where we can actually as a society admit that maybe this wasn’t as safe as we thought and until I start to see some evidence that we’re not trying to cover up some of the data that happened in the initial trials, I don’t want somebody using me as as a lab rat or a statistic to further push a narrative,” he added.