COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years

United States, June 18, 2022-August 21, 2022

Anne M. Hause, PhD; Paige Marquez, MSPH; Bicheng Zhang, MS; Tanya R. Myers, PhD; Julianne Gee, MPH; John R. Su, MD, PhD; Casey Parker; Deborah Thompson, MD; Sarada S. Panchanathan, MD; Tom T. Shimabukuro, MD; David K. Shay, MD

Disclosures

Morbidity and Mortality Weekly Report. 2022;71(35):1115-1120. 

In This Article

Abstract and Introduction

Introduction

On June 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for mRNA COVID-19 vaccines to include children aged 6 months–4 years for receipt of BNT162b2 (Pfizer-BioNTech) (administered as 3 doses, 3 μg [0.2 mL] each) and children aged 6 months–5 years for receipt of mRNA-1273 (Moderna) (administered as 2 doses, 25 μg [0.25 mL] each).[1,2] In preauthorization clinical trials, the Pfizer-BioNTech vaccine was administered to 3,013 children aged 6 months–4 years[3] and the Moderna vaccine was administered to 5,011 children aged 6 months–5 years.[4] Most adverse events reported in these trials were mild to moderate in severity and no serious vaccine-related adverse events were reported. To characterize postauthorization safety of COVID-19 vaccine primary series among young children, CDC reviewed adverse events and health impacts after receipt of Pfizer-BioNTech and Moderna vaccines that were reported to v-safe, a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination (https://vsafe.cdc.gov/en/), and the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system managed by CDC and FDA. During June 18–August 21, 2022, approximately 599,457children aged 6 months–4 years received the Pfizer-BioNTech vaccine and 440,773 aged 6 months–5 years received the Moderna vaccine*; approximately 23,266 children were enrolled in v-safe after mRNA COVID-19 vaccination. The most frequent systemic reactions reported to v-safe after receipt of Pfizer-BioNTech or Moderna vaccines were irritability or crying among approximately one half of children aged 6 months–2 years. Among children aged ≥3 years, systemic reactions after vaccination were less frequently reported; injection site pain was the most frequently reported reaction among these older children. VAERS received a total of 1,017 reports of adverse events after Pfizer-BioNTech or Moderna vaccination among children aged 6 months–4 years and children aged 6 months–5 years; 998 (98.1%) events were classified as nonserious and 19 (1.9%) as serious. No reports of myocarditis after vaccination were reported. These initial safety findings are similar to those from preauthorization clinical trials.[3,4] Health care providers and parents of young children should be aware that local and systemic reactions are expected after vaccination with Pfizer-BioNTech or Moderna vaccine and that serious adverse events are rare.

On June 20, 2022, v-safe was modified to allow parents and guardians to enroll children aged 6 months–4 years after any mRNA COVID-19 vaccine dose. Text message reminders are sent to parents or guardians to complete online health surveys for their child. Health surveys sent in the first postvaccination week include questions about local injection site and systemic reactions (i.e., mild, moderate, or severe) and health impacts.§ Specific questions were included for children aged 6 months–2 years who might not be able to describe reactions or who might experience reactions that are different from those experienced by children aged ≥3 years. CDC's v-safe call center contacts registrants who indicate that medical care was received after vaccination and encourages completion of a VAERS report.

VAERS is a national passive vaccine safety surveillance system managed by CDC and FDA that monitors adverse events after vaccination.[5] VAERS accepts reports of postvaccination adverse events from health care providers, vaccine manufacturers, and members of the public.** Signs, symptoms, and diagnostic findings in VAERS reports are assigned Medical Dictionary for Regulatory Activities preferred terms (MedDRA PTs) by VAERS staff.†† Reports of serious events to VAERS§§ were reviewed by CDC and FDA physicians to form a consensus clinical impression based on available data. Using selected MedDRA PTs, a search was performed to identify possible cases of myocarditis, a rare adverse event that has been associated with mRNA COVID-19 vaccines.[6]

Local and systemic reactions and health impacts reported to v-safe during the week after vaccination were described for children aged 6 months–4 years who received Pfizer-BioNTech vaccine and children aged 6 months–5 years who received Moderna vaccine during June 18–August 21, 2022. VAERS reports were described by serious and nonserious status, demographic characteristics, and MedDRA PTs. Analyses were conducted using SAS software (version 9.4; SAS Institute); p-values <0.05 were considered statistically significant. These surveillance activities were reviewed by CDC and conducted consistent with applicable federal law and CDC policy.¶¶

*The Pfizer-BioNTech COVID-19 vaccine for use in children aged 6 months–4 years was administered as 3 doses (3 μg [0.2 mL] each), at intervals of 3 weeks between doses 1 and 2 and ≥8 weeks between doses 2 and 3; the Moderna COVID-19 vaccine for use in children aged 6 months–5 years was administered as 2 doses (25 μg [0.25 mL] each), 4 weeks apart. Data for Moderna COVID-19 doses administered to children aged 5 years were unavailable. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic (Accessed August 16, 2022).
Children and adolescents aged ≤15 years cannot self-enroll and must be enrolled by a parent or guardian. Health check-ins are sent via text messages that link to web-based surveys on days 0–7 after vaccination; then weekly through 6 weeks after vaccination; and then 3, 6, and 12 months after vaccination.
§Parents and guardians describe the severity of the child's symptoms as mild, moderate, or severe. Severity of symptoms for registrants aged ≥3 years is defined as mild (noticeable, but not problematic), moderate (limit normal daily activities), or severe (make daily activities difficult or impossible). The definition of severity of symptoms among registrants aged ≤2 years is unique to each local injection site and systemic reaction. Health impacts among children include inability to perform normal daily activities, missed child care or school, or received care from a medical professional because of new symptoms or conditions.
These reactions were based on data collected in clinical trials and include groin or underarm swelling or tenderness, diarrhea, rash, vomiting, irritability or crying, loss of appetite, and sleepiness.
**Health care providers are required by COVID-19 vaccine EUAs to report certain adverse events after vaccination to VAERS, including death (https://vaers.hhs.gov/faq.html). A VAERS form includes patient information, vaccine information, vaccine administration information, and information regarding the adverse event (https://vaers.hhs.gov/docs/VAERS%202.0_Checklist.pdf).
††Each VAERS report might be assigned at least one MedDRA PT. A MedDRA coded event does not indicate a medically confirmed diagnosis. https://www.meddra.org/how-to-use/basics/hierarchy
§§VAERS reports are classified as serious (based on FDA Code of Federal Regulations Title 21) if any of the following are reported: hospitalization, prolongation of hospitalization, life-threatening illness, permanent disability, congenital anomaly or birth defect, or death. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr
¶¶45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq.

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