The 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 through 4 years of age, before clinical trials have shown the full course — three doses — to be effective. Such an authorization would be a first for the agency, many experts say.
In fact, interim results from the trial suggested that two doses of the vaccine did not produce a strong immune response in children aged 2 through 4. Results from trials of the third dose are expected in a few weeks.
The companies applied for authorization at the urging of the F.D.A., also highly unusual. The fast-moving pandemic has forced federal health officials to make important decisions with limited data before, and they argue that it’s important to begin vaccinating young children now, before a new, potentially more dangerous variant arrives.
But the agency’s review of incomplete data as a basis for authorization has alarmed some experts.
Read more at The New York Times.