Actionable Insights Newsletter

Translating research to power whole health

Issue 9   |    August 2024

A preliminary investigation into the safety of three COVID vaccines in US children

While most health outcomes showed no concerns, the statistical signals found for myocarditis or pericarditis in 12–17-year-olds post Pfizer-BioNTech vaccination and for seizures in 2–5-year-olds post Pfizer-BioNTech and Moderna vaccinations demand further research.

Enterprise Analytics Core domain(s): vaccines, COVID, community health, policy guidance

Summary

Background
Active monitoring of health outcomes in children after COVID-19 vaccination provides early detection of rare outcomes that may not be identified in prelicensure clinical trials.

Objective
To conduct near-real-time monitoring of health outcomes after COVID-19 vaccination in the US pediatric population.

Methods
This cohort study evaluated 21 prespecified health outcomes in children aged 6 months to 17 years after exposure to BNT162b2 (Pfizer-BioNTech), mRNA-1273 (Moderna), or NVX-CoV2373 (Novavax) ancestral monovalent COVID-19 vaccines. Near-real-time surveillance was applied using healthcare data from three commercial claims databases in the US, including Carelon Research. Rates of each outcome after vaccination were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020. This surveillance was able to rapidly identify less common safety concerns but does not establish any causal relationship between the vaccines and safety outcomes.

Results
Among 4,102,016 vaccinated enrollees aged 6 months to 17 years, 2,058,142 (50.2%) were male and 3,901,370 (95.1%) lived in an urban area. Carelon Research data represented more than 1/3 of the total sample. Of 15 outcomes, 13 did not meet the threshold for a statistical signal in any of the monthly evaluations. Statistical signals were detected for the combined myocarditis or pericarditis outcome after Pfizer-BioNTech vaccination in children aged 12 to 17 years and seizure after vaccination with Pfizer-BioNTech and Moderna in children aged 2 to 5 years. However, in post hoc sensitivity analyses, a statistical signal for seizure was observed only after Moderna vaccination when compared to 2019 background rates; no statistical signal was observed when compared to 2022 rates. No signals were identified for Novavax.

Key takeaways
In this cohort study of pediatric enrollees across three commercial health insurance databases:

• Statistical signals detected for myocarditis or pericarditis after Pfizer-BioNTech (ages 12-17 years) were consistent with previous reports;
• Seizures after Pfizer-BioNTech (ages 2-4 years) and Moderna vaccinations (ages 2-5 years) should be further investigated in a robust epidemiologic study with confounding adjustment.
• The US Food and Drug Administration concludes that the known and potential benefits of COVID-19 vaccination for Elevance Health insured children outweigh the known and potential risks of COVID-19 infection.

Publication

• Article: Hu M, Shoaibi A, Feng Y, et al. Safety of Ancestral Monovalent BNT162b2, mRNA-1273, and NVX-CoV2373 COVID-19 Vaccines in US Children Aged 6 Months to 17 Years. JAMA Netw Open. 2024;7(4):e248192. Published 2024 Apr 1. doi:10.1001/jamanetworkopen.2024.8192

Carelon Research project team: Daniel C. Beachler, Grace Stockbower, Shiva K. Vojjala, Ramya Avula, Brian Greenwald, Priyanka S. Sagare, Mia Si, Shiva Chaudhary, Ramin Riahi, Lauren Parlett, Ramin Riahi, and Dianna Hayden


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This study was conducted by Carelon Research, Inc., a subsidiary of Elevance Health, and funded by the FDA. Dissemination and sharing of the Newsletter is limited to Elevance Health and its subsidiaries and included findings and implications are for Elevance Health and its affiliates’ internal use only.