In autumn 2021 parents in the United States were asking doctors, and television medical correspondents such as CBS's Dr Jon LaPook, what they needed to know about vaccinating younger children against Covid-19. This page records the regulatory decisions made at the time. It is not medical advice; parents should speak to their child's doctor and check current guidance, which has changed since 2021.
The decisions
- 29 October 2021: The US Food and Drug Administration (FDA) issued an emergency use authorisation for the Pfizer-BioNTech vaccine for children aged 5 to 11. The pediatric dose was 10 micrograms, a third of the adult dose, given as two shots three weeks apart.
- 2 November 2021: The Centers for Disease Control and Prevention (CDC) director endorsed its advisory committee's recommendation that children in this age group be vaccinated.
The evidence considered
The FDA based its decision on a clinical trial involving several thousand children. The agency reported that the vaccine was about 91% effective at preventing symptomatic Covid-19 in the trial and that immune responses were comparable to those in young adults. Common side effects included a sore arm, tiredness and headache.
Regulators paid particular attention to myocarditis, a rare inflammation of the heart muscle that had been seen after mRNA vaccination, mostly in adolescent boys and young men. The trial was too small to detect very rare events, so the FDA and CDC committed to continued monitoring through existing safety systems.
The debate
Supporters argued that vaccination would reduce illness, hospitalisations and disruption to schooling. Some doctors and commentators argued that because severe disease was less common in young children, the balance of benefit and risk was closer than for adults, and that decisions should be left to families. Recommendations in other countries differed.
How the law works
An emergency use authorisation is a legal mechanism under US federal law that allows the FDA to authorise a medical product during a declared emergency when the known and potential benefits outweigh the known and potential risks, before full approval. It is a different, lower legal threshold than a full licence, a distinction that often gets lost in public argument.