FDA May Not Renew Authorization for Pfizer's Covid-19 Vaccine for Children Under 5

Strategic Insights -

US parents face growing challenges in vaccinating young children against Covid-19 this fall as the FDA may not renew authorization for Pfizer's vaccine for children under 5. The decision would significantly limit vaccine access for the most vulnerable children. Dr. Paul Offit, a pediatrician, expressed concerns that this would contradict the intent of shared clinical decision-making, making it confusing for parents to decide on their children's vaccination.

Key Takeaways:

  • The US FDA may not renew authorization for Pfizer's Covid-19 vaccine for children under 5, limiting vaccine access for the most vulnerable children.
  • This decision would contradict the intent of shared clinical decision-making, making it confusing for parents to decide on their children's vaccination.
  • Pfizer's vaccine is currently available for children under 5 through emergency use authorization (EUA), but full FDA approval is necessary for continued access.
  • Without FDA authorization, Pfizer's vaccine would no longer be available to children under 5, and Moderna's vaccine would need to be given "off-label" by a willing pharmacist or physician.
  • Dr. Paul Offit expressed concerns that this decision would put children at risk, citing data that children under 5 faced Covid-19 hospitalization rates comparable to those over 65.
  • The CDC's vaccine advisory committee heard evidence that children accounted for about 4% of all Covid-19 hospitalizations over the last fall and winter's respiratory virus season.
  • Covid-19 levels are on the rise in the US, with transmission increasing in at least 45 states, according to the CDC.

Statistics:

  • 4% of all Covid-19 hospitalizations were in children over the last fall and winter's respiratory virus season (CDC data).
  • Children under 5 faced 48 Covid-19 hospitalizations for every 100,000 children - nearly seven times the rate for older children and more than twice the rate for adults under 50 (CDC data).
  • Covid-19 transmission is increasing in at least 45 states (CDC data).

Sources:

  • "This decision would affect Pfizer's pediatric COVID-19 vaccine for children aged 6m-4y for the 2025-2026 season," the CDC's National Center for Immunization and Respiratory Diseases said in an email to state and local health officials.
  • US Health and Human Services Secretary Robert F. Kennedy Jr. announced in May that the CDC would no longer recommend Covid-19 vaccines for healthy children or pregnant women.
  • Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children's Hospital of Philadelphia, expressed concerns that this decision would contradict the intent of shared clinical decision-making.
  • Fatima Khan, co-founder of the nonprofit grassroots group Protect Their Future, stated that "taking a proven, safe and effective vaccine away from vulnerable children is unconscionable."
  • Moderna's Covid-19 vaccine was granted full approval by the FDA in July for those who are at "increased risk for COVID-19 disease."