A CDC report looked at 2 vaccine safety surveillance systems for the bivalent boosters in this population and there were no reports of myocarditis or death. Many of the reports were due to vaccine errors and not adverse events.
In the latest Centers for Disease Control and Prevention (CDC) MMWR Report, a review of both v-safe and the Vaccine Adverse Event Reporting System (VAERS) found the early safety findings from bivalent booster vaccination in children ages of 5–11 years old were similar to those described for monovalent booster vaccination in this age group.
“Approximately 99.8% of reports to VAERS for children aged 5–11 years after bivalent booster vaccination were nonserious. There were no reports of myocarditis or death after bivalent booster vaccination,” the investigators wrote. “Eighty-four percent of VAERS reports were related to vaccination errors, 90.5% of which did not list an adverse health event. Local and systemic reactions reported after receipt of a bivalent booster dose are consistent with those reported after a monovalent booster dose; serious adverse events are rare.”
“A vaccine administration error is any preventable event that may cause or lead to inappropriate medication use or patient harm,” the CDC states.
With this review, the findings were significant as there has been ongoing concerns from the public about the safety of COVID-19 vaccines. “The Preliminary safety findings from the first 11 weeks of bivalent booster vaccination among children aged 5–11 years are reassuring,” the investigators wrote.
In October of last year, the CDC recommended the bivalent COVID-19 booster vaccination for children aged 5–11 years, and the FDA issued an Emergency Use Authorization for the bivalent Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination for children aged 5–11 years (Pfizer-BioNTech) and 6–17 years (Moderna).
Approximately 953,359 bivalent booster doses were administered to children ages 5-11 years during the period of October 12, 2022–January 1, 2023.
It is important to note, the public and providers can report vaccine adverse events through VAERS or v-safe. The v-safe is a voluntary, smartphone-based US safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and VAERS is a US passive vaccine safety surveillance system co-managed by CDC and FDA. VAERS and v-safe are two of numerous monitoring systems government agencies are utilizing to detect concerns or possible safety signals for vaccines.
The investigators noted four limitations in their report. “First, v-safe is a voluntary program, and data might not be representative of the vaccinated population. Second, v-safe does not directly identify whether a vaccine is monovalent or bivalent; therefore, misclassification might occur among children who aged into this population without having completed a 3-dose primary series. Third, VAERS is a passive surveillance system and subject to reporting biases and underreporting, especially of nonserious events. Finally, conclusions drawn from these data are limited by the 11-week surveillance period; safety monitoring will continue during the bivalent booster vaccination program.”
It was also noted in this MMWR that vaccination was still recommended. The CDC’s Advisory Committee on Immunization Practices, “recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose ≥2 months after completion of a COVID-19 primary series or receipt of a monovalent booster dose.”