Mandatory Safety Evaluations Needed for mRNA COVID-19 Vaccines in Children with Comorbidities
A new study published in the journal *Infection* highlights the urgent need for pharmaceutical companies to rigorously evaluate the safety of mRNA COVID-19 vaccines in children with comorbidities. The study, conducted by researchers, found that children with pre-existing conditions experienced more adverse side effects after vaccination compared to their healthy peers.
Study Details and Findings
The researchers analyzed responses from 793 caregivers through an online survey. Participants included 179 children with comorbidities (median age 9, height 132 cm, weight 29 kg) and 614 healthy children (median age 8, height 135 cm, weight 30 kg). The most common comorbidities identified were pulmonary, rheumatologic, and cardiologic conditions. Caregivers completed the survey an average of 18 days (comorbidities) and 17 days (healthy children) after vaccination.
The study revealed that children with comorbidities reported experiencing symptoms more frequently after vaccination (76.54% vs. 72.31% in healthy children). Local reactions, such as swelling at the injection site, were the most common side effects reported in both groups. Children with comorbidities were significantly more likely to experience swelling at the injection site (odds ratio [OR], 2.01; 95% CI, 1.18-3.44).
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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.
Fatigue was the most commonly reported systemic side effect, affecting 12.87% of healthy children and 20.11% of children with comorbidities (OR, 1.71; 95% CI, 1.09-2.61).
Children with comorbidities also had significantly higher odds of experiencing the following side effects compared to healthy children:
- 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).
Importantly, no child in either cohort required hospitalization following the BNT162b2 vaccine, and there were no fatalities.
Limitations and Recommendations
The study acknowledges limitations including reliance on self-reported data and potential biases. The researchers emphasize the need for further research, particularly mandatory studies by pharmaceutical companies involving children with comorbidities, especially if vaccination recommendations target high-risk groups.
“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.
**Stay Informed and Protect Yourself**
Consulting with a healthcare professional is crucial for personalized advice regarding vaccinations and any potential risks or benefits based on individual health conditions.