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

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

Indications for Hospitalization in Children with SARS-CoV-2 Infection during the Omicron Wave in New York City

“…A minority of children with respiratory disease presented with croup. Our findings highlight the vulnerability of young children to COVID-19 hospitalizations and support the recent Advisory Committee on Immunization Practices recommendations for use of COVID-19 vaccine in children 6 months–4/5 years [ 23 ].…”

COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years — United States, June 18, 2022–August 21, 2022

“…The Advisory Committee on Immunization Practices recommends that all persons aged ≥6 months receive a COVID-19 vaccine (8). Initial vaccine safety monitoring in children aged 6 months-5 years are usually similar to those described in clinical trials, and no unexpected safety concerns were detected (3,4).…”

“…these age groups are authorized to receive a smaller amount of mRNA COVID-19 vaccine than are older children(8); incorrect dosing by vaccine administrators in different childhood age groups might lead to vaccination errors.…”

Safety of mRNA COVID-19 vaccines during pregnancy

“…6 In addition to being safe in pregnancy, other studies have shown that mRNA COVID-19 vaccines are effective www.thelancet.com/infection Published online August 11, 2022 https://doi.org/10.1016/S1473-3099(22)00443-1 at reducing the risk of severe illness in pregnant people and the risk of COVID-19 hospital admission among their infants younger than 6 months. 6,8 Protection in infants born to people vaccinated during pregnancy is particularly important because while mRNA COVID-19 vaccines were approved by the FDA on June 17, 2022, and recommended by the CDC on June 18, 2022, for children aged between 6 months and 5 years, 9 there are not currently any vaccines available for infants younger than six months.…”