Pediatric BNT162b2 Vaccine Is Safe in Children With, Without Comorbidities

It should be mandatory that pharmaceutical enterprises evaluate the safety of new mRNA COVID-19 vaccines in both healthy children and children with comorbidities, according to findings published in Infection. 

Researchers conducted a prospective, multicenter, industry-independent cohort study to compare the safety and side effects of the BNT162b2 vaccine in children with and without significant comorbidities. Children aged between 5 and 11 years who were vaccinated with BNT162b2 between December 2021 and March 2022 were eligible for inclusion. An online questionnaire was used to assess side effects in 10 categories, which included local symptoms at the vaccination site; general reactions; skin-related symptoms; symptoms regarding the musculoskeletal, pulmonary, nervous, gastrointestinal, or cardiovascular systems; otolaryngologic symptoms; or psychologic symptoms. The primary outcome was the relative frequency of categorized symptoms following vaccination with BNT162b2 in both cohorts. Bivariate analysis was used to compare the frequency of symptoms in both cohorts.

A total of 793 questionnaire responses were included in the study, 179 (median age, 9 years; median height, 132 cm; median weight, 29 kg) of which were from children with comorbidities and 614 (median age, 8 years; median height, 135 cm; median weight, 30 kg) of which were from healthy children. The most prevalent comorbidities were pulmonary, rheumatologic, and cardiologic conditions. The online survey was completed by caregivers of children with and without comorbidities at a median of 18 and 17 days after vaccination, respectively.

Any symptoms at all were reported more frequently by children with vs without comorbidities (76.54% vs. 72.31%). In both cohorts, local reactions were the most frequently reported side effects (healthy children, 63.36%; children with comorbidities, 67.60%). Children with vs without comorbidities reported more swelling on injection site (odds ratio [OR], 2.01; 95% CI, 1.18-3.44).

The most commonly experienced systemic symptom was fatigue, which was reported in 12.87% of healthy children and 20.11% of children with comorbidities (OR, 1.71; 95% CI, 1.09-2.61).

Compared with healthy children, children with comorbidities had higher odds of experiencing the following side effects:

• Psychologic (OR, 3.56; 95% CI, 1.46-8.62);
• Pulmonary (OR, 7.14; 95% CI, 2.04-21.48);
• Gastrointestinal (OR, 2.35; 95% CI, 1.23-4.67);
• Neurologic (OR, 1.74; 95% CI, 1.08-2.80); and
• Dermatologic (OR, 2.28; 95% CI, 1.22-4.17).

No child in either cohort had to be hospitalized after receiving the BNT162b2 vaccine and no fatalities occurred.

Study limitations include the reliance on self-reported data and potential bias.

“In general, it should be made mandatory for the respective pharmaceutical enterprises to perform studies in children with comorbidities, in particular if it becomes evident that recommendations for vaccination will focus on risk groups,” the researchers concluded.

Disclosure: One study author reported affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Infectious Disease Advisor