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yesterday

FDA Weighs Ending Pfizer COVID-19 Authorization for Children Under 5

If the authorization ends, providers will rely on off-label shots that carry risks of insurance coverage lapses or supply shortages.

A child gets her Covid-19 vaccination a licensed vocational nurse at the Santa Clara County Fairgrounds in San Jose, Calif., on Tuesday, June 21, 2022.
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Overview

  • The FDA has informed Pfizer it may not renew its emergency use authorization for the COVID-19 vaccine in children 6 months to 4 years, and Pfizer says discussions with the agency focus on next-season planning rather than safety or efficacy concerns.
  • Allowing the EUA to lapse would leave healthy under-5s without any officially authorized vaccine option, since Moderna’s fully approved shot is restricted to high-risk children and Novavax is not cleared for those under 12.
  • In May, HHS Secretary Robert F. Kennedy Jr. removed routine COVID-19 vaccine recommendations for healthy children and pregnant women, prompting the CDC to adopt shared clinical decision-making and the FDA to demand more rigorous trials for low-risk pediatric groups.
  • CDC data last season recorded 48 COVID-19 hospitalizations per 100,000 children under 5—higher than in any other age cohort—leading experts to warn that narrowed access could expose vulnerable infants during the fall respiratory season.
  • Clinicians and health departments are gearing up for patchwork off-label use amid unclear insurer obligations, uneven state ordering and potential supply shortages as the next virus season approaches.