Interim Recommendations of the Advisory Committee on Immunization Practices for Use of Moderna and Pfizer-BioNTech COVID-19 Vaccines in Children Aged 6 Months–5 Years — United States, June 2022
Katherine E. Fleming-Dutra, Megan Wallace, Danielle Moulia, Evelyn Twentyman, Lauren E. Roper, Elisha Hall, Ruth Link‐Gelles, Monica Godfrey, Kate R. Woodworth, Tara C. Anderson, Amy B Rubis, Edwin Shanley, Jefferson M. Jones, Rebecca L. Morgan, Oliver Brooks, H. Keipp Talbot, Grace M. Lee, Beth P. Bell, Matthew F. Daley, Sarah Meyer, Sara E. Oliver
Abstract
On June 18, 2022, ACIP voted 12 to 0 (three members absent) in favor of the interim recommendation for the use of the Moderna COVID-19 vaccine for children aged 6 months-5 years. ACIP voted 12 to 0 (three members absent) in favor of the interim recommendation for the use of the Pfizer-BioNTech COVID-19 vaccine for children aged 6 months-4 years. ModernaTX, Inc.) in persons aged 18 years, and the Moderna COVID-19 vaccine is also recommended under EUA for children and adolescents aged 6-17 years (1). On August 23, 2021, FDA approved a BLA for use of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty, Pfizer, Inc.) in persons aged 16 years, and the Pfizer-BioNTech COVID-19 vaccine is also recommended under EUA for children and adolescents aged 5-15 years (2). Recommendations regarding products, dosing intervals, and booster doses and for persons who are moderately to severely immunocompromised, which differ from recommendations for persons without immunocompromising conditions, are available at https://www.cdc.gov/vaccines/ covid-19/clinical-considerations/covid-19-vaccines-us.html. As of June 17, 2022, among persons aged 18 years, 223 million doses of the Moderna COVID-19 vaccine have been administered in the United States, and among persons aged 5 years, 349 million doses of the Pfizer-BioNTech COVID-19 vaccine have been administered (3). Since June 2020, ACIP has convened 28 public meetings to review data relevant to the epidemiology of COVID-19 and considerations for the use of COVID-19 vaccines, including the Moderna and Pfizer-BioNTech COVID-19 vaccines. The ACIP COVID-19 Vaccines Work Group (Work Group), comprising experts in pediatrics, infectious diseases, vaccinology, vaccine safety, public health, and ethics, has held weekly meetings to review COVID-19 surveillance data; evidence for vaccine efficacy, postauthorization effectiveness, and safety; and implementation considerations for COVID-19 vaccines. To guide its deliberations regarding recommendations for use of these vaccines, ACIP used the Evidence to Recommendation (EtR) Framework and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Within the EtR Framework, ACIP considered the importance of COVID-19 as a public health problem, as well as parents' values and preferences, acceptability, feasibility, resource use, and equity regarding use of mRNA COVID-19 vaccines among children aged 6 months-5 years. Consistent with the age groups for each https://www.cdc.gov/vaccines/acip/meetings/index.html https://www.cdc.gov/vaccines/acip/recs/grade/downloads/acip-evidence-recsframework.pdf https://www.cdc.gov/vaccines/acip/recs/grade/about-grade.html ** https://www.cdc.gov/vaccines/acip/recs/grade In the Moderna COVID-19 vaccine clinical trial, symptomatic, laboratory-confirmed COVID-19 was defined based on the CDC case definition, which required at least one clinical symptom (fever 100.4F [38C], chills, fatigue, headache, myalgia, nasal congestion or rhinorrhea, new loss of taste or smell, sore throat, abdominal pain, diarrhea, nausea or vomiting, poor appetite or poor feeding, cough, or shortness of breath or difficulty breathing), and a positive COVID-19 test result using reverse transcription-PCR (RT-PCR). In the Moderna COVID-19 vaccine clinical trial, approximately 10% of children aged 6 months-5 years were seropositive, indicating previous SARS-CoV-2 infection, at baseline.