More Research Needed on Efficacy of Vaccinations for Pediatric Patients on Biologics


There was an adequate response for pediatric patients on biologics to the H1N1 and H3N2 serotypes.

More Research Needed on Efficacy of Vaccinations for Pediatric Patients on Biologics

More research is needed on the efficacy of vaccinations for pediatric patients with diseases like inflammatory bowel disease (IBD) and juvenile idiopathic arthritis who are treated with biologics.

A team, led by Chiara Gertosio, Pediatric Clinic, Fondazione IRCSS-Policlinico San Matteo, University of Pavia, evaluated the efficacy, immunogenicity, and safety of vaccines in pediatric patients with chronic conditions treated with biologics.

The Patients

Pediatric patients with chronic diseases treated with biologics are at an increased risk of infection.While this increases the importance of vaccinations, the response in this patient population is not well understood.

In the systematic review, the investigators analyzed studies published between 2009-2019 that focus on vaccinations in pediatrics with chronic conditions treated with biologics.

Overall, there were 532 records identified with 31 full-text articles selected and 14 included in the final analysis. There was no significant publication bias found.

Efficacy and Immunogencity

The investigators found limited data available on the efficacy of vaccinations in this patient population. The majority of studies focused on immunogenicity as surrogate outcomes for efficacy.

For immunogenicity, the investigators found patients receiving anti-TNF-alpha therapy had a statistically significant risk of poor seroconversion (P = 0.028) and seroprotection by the serotype B influenzas vaccine (inflammatory bowel disease: P = 0.013; juvenile idiopathic arthritis: P = 0.004).

There was also adequate responses to H1N1 and H3N2 serotypes.

In addition, very few studies focused on pneumococcal, hepatitis A virus. Hepatitis B virus, varicella-zoster virus, Measles Mumps Rubella virus, and multiple vaccine administration.


Finally for safety, vaccine administration was not associated with serious side effects.

However, patients with juvenile idiopathic arthritis on anti-TNF alpha therapy had a statistically significant risk of presenting with myalgia or arthralgia postinfluenza vaccine (P = 0.014).

“More evidence concerning efficacy, immunogenicity, and safety of vaccinations is needed to guide physicians in the vaccine decision process for this pediatric population,” the authors wrote.

IBD and Vaccinations

Earlier this year, investigators found fully-vaccinated patients with (IBD) are at a lower risk of severe COVID-19 outcomes, hospitalizations, and death than their unvaccinated counterparts.

Included in the analysis were patients with IBD who received at least 1 vaccine dose prior to their diagnosis of COVID-19. Vaccinations included mRNA (Pfizer and Moderna), adenovirus vector (CanSino, AstraZeneca, Sputnik, and Janssen), or inactivated SARS-CoV-2 (Sinovac) vaccines. The investigators also defined partial vaccination as not having received the full complement of doses for the vaccine.

The investigators sought main outcomes of hospitalization, death, and severe COVID-19, a composite of intensive care unit admission, mechanical ventilation, and/or death.

Overall, the team identified 141 cases. Of this group, 8.5% (n = 12) were hospitalized, 2.8% (n = 4) had severe COVID-19, and 0.7% (n = 1) died.

However, these numbers were significantly lower than a comparison group of unvaccinated individuals. Within this same time period, 9.3% of unvaccinated individuals were hospitalized, 1.9% had severe COVID-19 infections, and 1.2% died.

For example, approximately 75% of patients with IBD and COVID-19 following vaccination were on biologics, with around 33% taking immunomodulators.

They also found fewer hospitalizations occurred in individuals who completed the vaccine series compared to partially completing the vaccine series (5.7% vs 13.2%; P = 0.13).

The study, “Efficacy, immunogenicity, and safety of available vaccines in children on biologics: A systematic review and meta-analysis,” was published online in Vaccine.

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