The National Institutes of Health (NIH) is carrying out a single-center trial to examine the allergic reactions to COVID-19 mRNA vaccines.

Researchers at the National Institute of Allergy and Infectious Diseases (NIAID) will enrol 100 vaccine recipients, aged 16-69 years, who suffered a mild or moderate systemic allergic reaction to the first dose of the mRNA vaccine, either Pfizer-BioNTech or Moderna. They would be given the second dose as part of the trial at the NIH’s Clinical Center in Bethesda, Maryland. All the participants would be hospitalized in the ICU for at least four days for monitoring and prompt management of severe allergic reactions, should they occur. Those with severe allergic reactions will be excluded from the trial.

Each study subject would be randomly assigned to receive either the Pfizer COVID-19 mRNA vaccine or a placebo on consecutive days. All participants will be given the vaccine on one of the two days. Blood samples would be collected. They would be required to fill out mental health/anxiety questionnaires before, at the time of and after vaccination. All participants would be followed up at one month and after five months post-vaccination. Those individuals who did not develop any allergic reaction up to 5 months would be given a booster dose of Pfizer vaccine.

Researchers are hopeful that the findings of the study would allay the fears of people who developed an allergic reaction to the first dose of the mRNA COVID-19 vaccine and are therefore reluctant to take the second dose.

Source: National Institutes of Health, March 9, 2022