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Interim Recommendations of the Advisory Committee on Immunization Practices for


Recommendations for the Use of the Moderna COVID-19 Vaccine in Children Aged 6 Months–5 Years and the Pfizer-BioNTech COVID-19 Vaccine in Children Aged 6 Months–4 Years

Data reviewed with the EtR Framework supported the use of COVID-19 vaccine in children aged 6 months–5 years. COVID-19 is a major public health problem among young children. As of June 12, 2022, approximately 2 million COVID-19 cases, 20,000 hospitalizations, and 200 deaths from COVID-19 have been reported among U.S. children aged 6 months–4 years (7,8). The SARS-CoV-2 Omicron variant emerged in the United States in December 2021 and led to the highest COVID-19 incidence, rates of COVID-19–associated emergency department visits and COVID-19–associated hospitalization among children aged 6 months–4 years yet seen during the pandemic (9). Approximately one half (51%–54%) of children aged 6 months–4 years with a COVID-19–associated hospitalization had no underlying health conditions, highlighting the risk for severe COVID-19 even among young children without underlying health conditions (9). During the period of Omicron predominance, illness among children aged 6 months–4 years with COVID-19–associated hospitalizations was as severe or more severe than that among children and adolescents aged 5–17 years, who were eligible for COVID-19 vaccination during that period (9). Furthermore, COVID-19 hospitalization rates among children aged 6 months–4 years during October 2021–April 2022 were as high or higher than were influenza-associated hospitalization rates during the 2017–18, 2018–19, and 2019–20 influenza seasons (10).

SARS-CoV-2 can also lead to complications after acute infection. MIS-C is a severe illness in persons aged <21 years that occurs 2–6 weeks after SARS-CoV-2 infection and is characterized by fever, multisystem organ involvement, and laboratory evidence of inflammation (11). As of May 31, 2022, CDC has received 8,525 reports of cases of MIS-C in the United States, including 69 deaths (12); children aged 6 months–4 years account for 1,990 (23%) of these cases and 9 (13%) of the deaths among MIS-C cases (9). Post–COVID-19 conditions, which include a range of new, returning, or ongoing, health problems occurring ≥4 weeks after acute SARS-CoV-2 infection, also occur in children, including those aged <5 years (1315). However, evidence regarding the prevalence and spectrum of these conditions in children, especially young children, is limited by the inability of younger children to verbalize symptoms, few studies that include children, lack of appropriate control groups, and because symptoms similar to those seen in post–COVID-19 conditions are frequently reported among children without known SARS-CoV-2 infection (13,14,16).

The pandemic has also had additional indirect effects on children and families, including missed routine childhood immunizations and health care visits; worsening of children’s social, emotional, and mental well-being; and disruptions in early child care and education programs (1719). In a survey conducted during July 15–August 2, 2021, 39% of parents reported that an adult in their household either left a job or changed work schedules to care for children during the past year; parents of a child aged <5 years, Black and African American parents, Hispanic or Latino parents, and parents with an annual household income of <$40,000 were most likely to report household job disruptions (20). COVID-19 vaccination in this age group may provide parents with increased confidence to return to prepandemic activities, improving social interactions in young children.

Implementation of these recommendations will require educating vaccine providers about the correct age-appropriate product (Table 1) and vaccination schedule (Table 2) for each vaccine, to avoid vaccine administration errors. ACIP determined that use of the Moderna and Pfizer-BioNTech COVID-19 vaccines among children is a reasonable and efficient allocation of resources. To expand COVID-19 vaccine access, additional considerations should be given to demographic groups that have experienced disproportionate COVID-19 morbidity and mortality, as well as those with barriers to routine health care (e.g., members of certain racial and ethnic groups and those living in a rural area, experiencing homelessness, or lacking health insurance). Children from racial and ethnic minority groups have experienced a disproportionately high incidence of COVID-19, associated hospitalization, and MIS-C (7,12,21). Pediatricians and health care providers remain the most trusted source among parents for information about COVID-19 vaccines for children (22). Based on the National Immunization Survey-Child COVID Module interviews conducted in May 2022, 33.5% of parents said they would definitely vaccinate their child aged 6 months–4 years for COVID-19, once eligible, and 19.6% said they would probably vaccinate their child aged 6 months–4 years (7). Thus, pediatricians and other primary care providers who care for children will be critical to increasing COVID-19 vaccine confidence among parents and coverage with COVID-19 vaccine among young children.

ACIP reviewed the balance of known and potential benefits and risks regarding the use of the Moderna COVID-19 vaccine in…



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