Abstract and Introduction
On June 17, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) amendments for the mRNA-1273 (Moderna) COVID-19 vaccine for use in children aged 6 months–5 years, administered as 2 doses (25 μg [0.25 mL] each), 4 weeks apart, and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine for use in children aged 6 months–4 years, 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. On June 18, 2022, the Advisory Committee on Immunization Practices (ACIP) issued separate interim recommendations for 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 for the prevention of COVID-19.* Both the Moderna and Pfizer-BioNTech COVID-19 vaccines met the criteria for immunobridging, which is the comparison of neutralizing antibody levels postvaccination in young children with those in young adults in whom efficacy had been demonstrated. Descriptive efficacy analyses were also conducted for both Moderna and Pfizer-BioNTech COVID-19 vaccines during the period when the Omicron variant of SARS-CoV-2 (the virus that causes COVID-19) predominated. No specific safety concerns were identified among recipients of either vaccine. ACIP recommendations for the use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine in children aged 6 months–5 years and 6 months–4 years, respectively, are interim and will be updated as additional information becomes available. Vaccination is important for protecting children aged 6 months–5 years against COVID-19.
The Moderna and Pfizer-BioNTech COVID-19 vaccines are lipid nanoparticle–formulated, nucleoside-modified mRNA vaccines encoding the prefusion spike glycoprotein of SARS-CoV-2. On January 31, 2022, FDA approved a Biologics License Application (BLA) for use of the Moderna COVID-19 vaccine (Spikevax, 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. 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. 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.
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 vaccine included under EUA, ACIP also considered, within the EtR Framework, the benefits and harms of using each vaccine (i.e., the Moderna COVID-19 vaccine among children aged 6 months–5 years and the Pfizer-BioNTech COVID-19 vaccine among children aged 6 months–4 years), independently compared with no vaccine. After conducting systematic reviews of published and unpublished evidence for benefits and harms, the Work Group used the GRADE approach to independently assess the certainty of evidence for outcomes related to the Moderna and Pfizer-BioNTech COVID-19 vaccines, rated on a scale of type 1 (high certainty) to type 4 (very low certainty).** Work Group conclusions regarding evidence for the use of Moderna COVID-19 vaccine among children aged 6 months–5 years and Pfizer-BioNTech COVID-19 vaccine among children aged 6 months–4 years were presented to ACIP at a public meeting during June 17–18, 2022.
Morbidity and Mortality Weekly Report. 2022;71(26):859-868. © 2022 Centers for Disease Control and Prevention (CDC)