The U.S. Food and Drug Administration’s upcoming review of the Pfizer-BioNTech coronavirus vaccine for young children is without precedent in recent history.
Next week, scientific advisers to the agency will decide whether to endorse two doses of the vaccine for children 6 months to 4 years old, before clinical trials have shown the full, three-dose course to be effective. Such an authorization would be a first for the agency, many experts say.
Interim results from the trial suggest that two doses of the vaccine does not produce a strong immune response in children age 2 to 4. Results from trials of the third dose are expected in a few weeks.