Pfizer-BioNTech Vaccine Effectiveness Comparable in IBD Patients, General Population

By Marilynn Larkin

July 16, 2021

NEW YORK (Reuters Health) - Preliminary real-world data from a mass vaccination campaign in Israel show that COVID-19 vaccine effectiveness in inflammatory bowel disease (IBD) patients was comparable to that of the general population, researchers say.

"We matched patients (with and without IBD) by age, sex, vaccine month and relevant comorbidities, then evaluated their risk of getting a positive PCR test result," Dr. Amir Ben-Tov of the Maccabi Institute for Research and Innovation in Tel Aviv told Reuters Health by email. "Absolute breakthrough infection cases were scarce in all patients with IBD, including those who are currently treated with immune-modifying agents such as biologic therapies and systemic steroids."

"We are continuously gathering data and will update our findings as soon as we have new information about the effect of the delta variant in patients with IBD," he noted.

Meanwhile, he said, "You can reassure your patients that they are protected to the same (extent) as their healthy peers."

As reported in Gastroenterology, Dr. Ben-Tov and colleagues matched BNT162b2 mRNA COVID-19 (Pfizer-BioNTech) vaccine recipients with patients from an IBD registry who were vaccinated between December 2020-March 2021.

Overall, data from 12,231 IBD patients and 36,254 individuals without IBD were analyzed. In both groups, the mean age was 47 and half were women. The median follow-up was 71 days, and the median days between vaccine doses was 21.

"Despite the wide use of immune-modifying medications, vaccine effectiveness in our study cohort was high," the authors note.

Breakthrough infection rates more than a week after the second dose were 0.19% in those with IBD and 0.15% in those without; breakthrough rates more than two weeks after the second dose were 0.14% and 0.10% respectively.

The relative risk (RR) of breakthrough infection for IBD was 1.21 >7 days after the second dose and 1.26 >14 days after.

Among 23 IBD patients with a positive PCR >7 days after the second dose, nine were symptomatic; two were hospitalized; and one - an 88-year-old man with ulcerative colitis (UC) - died 17 days after his second dose.

Further analyses showed that compared to their matched peers, Crohn's disease (CD) patients were at a greater risk for breakthrough infection, whereas no significant difference was seen for UC.

The RR for CD and matched individuals was 1.52 >7 days after the second dose and 1.82 >14 days after; for UC, the RR was 0.53 >7 days after the second dose and 0.95 >14 days after.

Multivariable Cox proportional hazard models showed that patients with CD had a higher risk of breakthrough infection compared to those with UC >7 days and >14 days after the second dose, with HRs of 3.56 and 3.38, respectively.

No increased risk was seen for patients treated with immune-modifying therapies

Gastroenterologist Dr. Niket Sonpal, course director at Touro College of Osteopathic Medicine in New York City, commented on the study in an email to Reuters Health. "The results are very encouraging and do demonstrate the need for ongoing vaccination in patients with chronic medical conditions."

"However," he said, "these data come from one cohort and large studies with various patient demographics would be helpful to see if this will apply to patients in other countries as well."

"My instincts tell me, however, that the vaccines are highly effective, as seen in this one study," he concluded.

SOURCE: https://bit.ly/36APAzC Gastroenterology, online July 2, 2021.

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