ORLANDO, Florida – People with inflammatory bowel disease (IBD) who received a third dose of COVID-19 vaccine – i.e., a booster shot — did not appear to be at risk of greater adverse events (AEs) than those without IBD, a small study showed.
Paola Lopez-Marte, MD, a research fellow in gastroenterology at the University of Puerto Rico-Medical Science Campus in San Juan, said that among the 62 patients in Puerto Rico diagnosed with IBD, those who had their third COVID shot had a side effect profile similar to both the first dose (P=0.67) and second dose (P=0.58) of the vaccine.
The difference between doses 1 and 2 was not statistically different (P=0.24), Lopez-Marte said at her poster presentation at the Advances in Inflammatory Bowel Diseases annual meeting.
The most common AE was pain at the injection site. About 75% of patients receiving their first dose of the vaccine reported that AE but by the third dose, the percentage had dropped to 44%.
Injection site reactions were far more prevalent than any systemic events, Lopez-Marte noted. Other AEs that were part of the general profile for all three doses of the vaccine were:
- Fatigue, experienced by 17% of patients getting their third shot
- Joint or muscle pain, experienced by 14% of the individuals getting their third shot
- Headache, experienced by about 13% of the participants in the study overall
None of the individuals required hospitalization for AEs, Lopez-Marte said.
Patients received either the Pfizer-BioNTech or Moderna vaccine. “We interviewed the patients 2 weeks to 2 months after receiving their vaccine shots to assess their perceived adverse effects,” Lopez-Marte noted. “Our results show that side effects of COVID-19 immunizations in patients with inflammatory bowel disease demonstrate a safe profile after receiving three doses.”
Four participants developed a fever after the third administration but none reported abdominal pain, she added. “Furthermore, we did not observe a correlation between vaccine administration and disease activity.”
The study was conducted because people on immunosuppressive therapy were routinely excluded from COVID-19 vaccine clinical trials, Lopez-Marte said. Previous studies indicated that among patients diagnosed with IBD, vaccine AEs for the first two doses were similar to what was seen in the general population, she noted. However, there had not been evaluation of what happened when patients had a booster shot.
The research was conducted prior to recommendations for a second booster (i.e., a fourth shot) or the bivalent booster specifically aimed at Omicron strains of SARS-CoV-2 virus. Participants were 21 or older, had either Crohn’s disease or ulcerative colitis, and were or were not receiving biological or immunomodulatory therapy.
Carmen Paniagua, EdD, MSN, ACNP-BC, an instructor in nursing at the University of Arkansas for Medical Sciences in Little Rock, called the study important and “confirmatory to what the literature had found in different ethnic populations — this is a completely Hispanic population.”
“This is good validation that the vaccine does not create any additional adverse responses in this population,” Paniagua, who was not involved with the study, told MedPage Today.
Lopez-Marte acknowledged that the numbers in the study were relatively small. “It would be interesting to evaluate the role that biologic therapy and/or immunomodulatory therapy might play in the development of adverse events,” she said. “A larger sample is needed to ensure overall safety and with long-term surveillance.”
Lopez-Marte and Paniagua did not have any disclosures.