FDA May Discontinue Authorization For Pfizer’s COVID-19 Vaccine In Children Under Age 5

The New York Times (8/11, Mandavilli) reports that the FDA may discontinue emergency use authorization for Pfizer’s COVID-19 vaccine for children under 5, “according to an email sent by the Centers for Disease Control and Prevention to state and local health departments.” If the FDA does not renew reauthorization “for children 6 months to 4 years, or fully approve the vaccine, healthy children in that age group will have no officially sanctioned options” to be vaccinated against COVID-19, although doctors may opt to provide the vaccine “off label.” Pfizer confirmed the possibility Monday evening and “said that the company was ‘currently in discussions with the agency on potential paths forward.’” CNN (8/12, McPhillips, Goodman, Tirrell) adds that Pfizer “has had full FDA approval for its COVID-19 vaccine for individuals age 12 and older since 2022. The company anticipates that this approval will expand to children ages 5 to 11 for the upcoming respiratory virus season, according to the email that the CDC’s National Center for Immunization and Respiratory Diseases sent to state and local health officials on Friday.” Meanwhile, Moderna “has a COVID-19 vaccine available for children age 11 and younger. It was granted full approval by the FDA in July but only for those who are at ‘increased risk for COVID-19 disease.’” According to the CDC email, Moderna plans to increase vaccine supply for children to “help mitigate any potential supply gap.”