On June 18, the U.S. Centers for Disease Control and Prevention (CDC) officially recommended Pfizer and Moderna COVID-19 vaccines for all children between the ages of 6 months and 5 years. While the Food and Drug Administration (FDA) is the agency responsible for authorizing emergency use of vaccines, it's the CDC that crafts subsequent messaging, makes specific recommendations, and prioritizes who can, should, or should not get vaccinated. In her briefing, CDC Director Rochelle Walensky strongly urged all parents of the nearly 20 million American children in this age group to vaccinate them as soon as possible. There remains ... no solid consensus among physicians about the importance of vaccinating healthy children against COVID-19. In a Food and Drug Administration (FDA) meeting on June 28, Pfizer Vice President for Viral Vaccines Kena Swanson even acknowledged that "there is no established correlate" between antibody levels and protection from disease. Approval for the COVID vaccines in infants and toddlers is based on two trials that used changes in antibody levels as an estimate of efficacy, but did not assess protection from severe disease, hospitalization, or multisystem inflammatory syndrome in children (MIS-C), important outcomes that parents worry about. Additionally, neither trial met the 50% efficacy requirement established by the FDA for approval of adult COVID vaccines. More puzzling is the fact that ... the pediatric vaccines now being administered target an outdated variant.
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