A medical worker prepares to administer a dose of the coronavirus disease vaccine for 5-11 year old kids [File image]
On Friday, the agency said it had reviewed new trial information that had come in since Pfizer and BioNTech’s request for emergency authorization and decided it needed more data before moving forward. Pfizer and BioNTech had submitted data on the first two doses of what was planned as a three-dose regimen for this age group earlier this month at the request of the FDA. It did not disclose efficacy data.
“This is a three-dose vaccine, and they were going to be presenting data on the first two doses. It makes sense to wait for the safety and efficacy data on all three doses to be available before we make a decision about this vaccine,” said Dr. Paul Offit from Children’s Hospital of Philadelphia.