Newswise — OAKLAND, Calif. —A study published on June 6 in Pediatrics, conducted by the Kaiser Permanente Division of Research in collaboration with the Centers for Disease Control and Prevention, examined over 245,000 administrations of mRNA COVID-19 vaccines among young children, primarily aged 4 and below. No substantial adverse effects were detected in the review.

Patient medical information for the study was sourced from the Vaccine Safety Datalink, a database that gathers data from eight healthcare systems. These systems include five regions of Kaiser Permanente, along with Marshfield Clinic in Wisconsin, HealthPartners in Minneapolis, and Denver Health in Colorado. The researchers analyzed patient records between June 2022 and March 2023, encompassing both Pfizer and Moderna vaccines.

Lead author Kristin Goddard, MPH, who serves as the research project manager at the Kaiser Permanente Vaccine Study Center, emphasized that the study yielded no evidence of myocarditis, a form of heart inflammation, in the vaccinated children. Goddard expressed reassurance regarding this finding, stating, "We haven't observed any cases of myocarditis or pericarditis in this particular age group, which is highly reassuring."

In previous publications based on the Vaccine Safety Datalink, rates of myocarditis associated with COVID-19 vaccination have been reported primarily among teenage or young adult men, highlighting it as a rare side effect. However, data regarding myocarditis rates following COVID-19 vaccination in children over 5 years old and young adults have been previously published from the same database.

The Pediatrics study represents the inaugural analysis investigating the presence of severe side effects resulting from mRNA vaccines in young children. The examination scrutinized medical records for 23 potential serious side effects, encompassing conditions such as blood clots, seizures, stroke, and brain inflammation. The analyses conducted indicated no discernible safety issues pertaining to any of the selected serious side effects. Notably, the study revealed no cause for alarm regarding seizures occurring post-vaccination, an occurrence occasionally observed following routine childhood immunizations in children below 2 years of age.

The analysis encompassed a substantial and diverse cohort of children, incorporating a total of 135,005 administrations of the Pfizer COVID-19 vaccine to children aged 6 months to 4 years, and 112,006 administrations of the Moderna COVID-19 vaccine to children aged 6 months to 5 years. The inclusion of such a large and varied group enhances the robustness and generalizability of the study's findings.

Senior author Nicola Klein, MD, PhD, who serves as the director of the Kaiser Permanente Vaccine Study Center and a research scientist with the Division of Research, reassured parents by stating, "Parents can be assured that this extensive study detected no significant adverse effects resulting from the mRNA vaccines." Dr. Klein further emphasized that parents can safeguard their young children against COVID-19 in the same manner they immunize them against other critical childhood illnesses.

Dr. Klein added, "Despite the conclusion of the COVID-19 emergency, it is crucial to recognize that the coronavirus continues to present a significant and enduring threat to individuals of all age groups, including children." Dr. Klein stressed the importance of vaccinating children against COVID-19, explaining that it not only reduces the impact of the disease on their well-being but also helps prevent the transmission of the virus to their family members and the broader community. Additionally, vaccinating children helps mitigate the small yet existent risk of severe illness.