The U.S. Food and Drug Administration (FDA) has granted emergency authorization to the updated Pfizer-BioNTech COVID-19 vaccine as a booster for children as young as 6 months old, even though Pfizer has produced no clinical efficacy data for any age group.
None of the trial data has been released to the public.
The authorization means children aged 6 months to 5 years will be encouraged to get a booster dose just two months after the final dose of a three-dose Pfizer primary series.

The authorization provides parents “an opportunity to update their children’s protection by receiving a booster dose” of the updated vaccine, Dr. Peter Marks, an FDA official, said in a statement. “Currently available data show that vaccination remains the best defense against severe disease, hospitalization and death caused by COVID-19 across all age groups, and we encourage all eligible individuals to make sure that their vaccinations are up to date with a bivalent COVID-19 vaccine.”
The authorization is for the prevention of COVID-19 disease.
The expanded authorization was also based on data for people who aren’t in the age group in question, including elderly people, and safety and effectiveness data for the monovalent vaccines, which were first rolled out in late 2020.
Some experts have said the vaccines shouldn’t be authorized without clinical efficacy data. Some have said the new vaccines aren’t necessary for most or all people, especially those who recovered from COVID-19. Others say the updated shots are a good option for people to have to boost antibodies, which are believed to protect against the disease.
Pfizer and BioNTech said earlier in the month that among 60 participants under 5, a fourth dose of the bivalent elicited a higher level of neutralizing antibodies compared to children in the age group who received three doses of the monovalent vaccine. The companies also said that the safety profile of the updated shot was “similar to that of the original vaccine.”