![]() ![]() Local reactions were reported for 215 (19.9%) children aged 6 months–2 years and 304 (36.9%) aged 3–4 years after Pfizer-BioNTech vaccination and for 179 (30.9%) aged 6 months–2 years and 252 (52.1%) aged 3–5 years after Moderna vaccination. Local and systemic reactions reported after receipt of either Pfizer-BioNTech or Moderna vaccines were most commonly reported (930 53.2%) on the day after vaccination 1,119 (37.7%) children had no reported reactions ( Table 1). Concomitant receipt of another vaccine was reported for 437 (22.9%) children who received Pfizer-BioNTech and 66 (6.2%) who received Moderna most (423 84.1%) children received co-administered influenza vaccine. †††ĭuring June 17, 2022–May 7, 2023, a total of 2,969 v-safe registrants aged 6 months–5 years received a third COVID-19 vaccine dose and had at least one health survey completed l,082 aged 6 months–2 years and 823 aged 3–4 years received Pfizer-BioNTech vaccine and 580 aged 6 months–2 years and 484 aged 3–5 years received Moderna vaccine. These activities were reviewed by CDC and conducted consistent with applicable federal law and CDC policy. All analyses were conducted using SAS software (version 9.4 SAS Institute). Serious reports*** and reports not specifying vaccination error were reviewed by CDC physicians to form a consensus clinical impression based on available data. VAERS reports were described by serious and nonserious classification, demographic characteristics, and MedDRA PTs. ¶¶ Local and systemic reactions and health impacts reported during the week after vaccination were described for v-safe registrants aged 6 months–5 years. This report includes data for children aged 6 months–5 years who received a third mRNA COVID-19 dose during June 17, 2022–May 7, 2023. †† Signs, symptoms, and diagnoses reported to VAERS are assigned Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs) by VAERS staff members. VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public. CDC’s v-safe call center contacts registrants who report receiving medical care to request more information registrants are encouraged to complete a VAERS report, if indicated. ¶ A parent with a v-safe account could register a child or adolescent aged <16 years, receive text message reminders, and complete health surveys on behalf of the child.** Health surveys sent daily during the week after vaccination inquire about local injection site and systemic reactions and health impacts respondents can provide additional information via free-text responses. Starting June 19, 2022, parents could enroll children aged 6 months–4 years in v-safe after mRNA COVID-19 vaccination. Health care providers can counsel parents and guardians of young children that most reactions reported after vaccination with Pfizer-BioNTech or Moderna vaccine were mild and transient and that serious adverse events are rare. Preliminary safety findings after a third dose of COVID-19 vaccine for children aged 6 months–5 years are similar to those after other doses. § No new safety concerns were identified. VAERS received 536 reports after a third dose of mRNA COVID-19 vaccine for children in these age groups 98.5% of reports were nonserious and most (78.4%) were classified as a vaccination error. † A third mRNA COVID-19 vaccination was recorded for 2,969 children in v-safe approximately 37.7% had no reported reactions, and among those for whom reactions were reported, most reactions were mild and transient. During June 17, 2022–May 7, 2023, approximately 495,576 children aged 6 months–4 years received a third dose (monovalent or bivalent) of Pfizer-BioNTech vaccine and 63,919 children aged 6 months–5 years received a third dose of Moderna vaccine. passive vaccine safety surveillance system co-managed by CDC and the Food and Drug Administration (FDA) ( ) ( 5). safety surveillance system established by CDC to monitor health after COVID-19 vaccination ( ) and the Vaccine Adverse Event Reporting System (VAERS), a U.S. ![]() To characterize the safety of a third mRNA COVID-19 vaccine dose among children aged 6 months–5 years, CDC reviewed adverse events and health surveys reported to v-safe, a voluntary smartphone-based U.S. Initial vaccine safety findings after primary series vaccination among children aged 6 months–5 years showed that transient local and systemic reactions were common whereas serious adverse events were rare ( 4). Depending on their COVID-19 vaccination history and history of immunocompromise, these children might also need additional doses* ( 1– 3). As of May 7, 2023, CDC’s Advisory Committee on Immunization Practices (ACIP) recommends that all children aged 6 months–5 years receive at least 1 age-appropriate bivalent mRNA COVID-19 vaccine dose.
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