A US decision on Pfizer and BioNTech’s Covid-19 vaccine for children ages 6 months to 4 years was delayed for at least two months after the US Food and Drug Administration (FDA) said it needed of more data.
The FDA was planning to make a decision on the vaccine based on initial data from the trials because of what it called a great public health need due to the rise in infections caused by the omicron variant of the coronavirus. The decision was scheduled for next week.
On Friday, the agency said it had reviewed new testing information that had come in since Pfizer and BioNTech’s emergency authorization application and decided it needed more data before moving forward.
“If something doesn’t meet that standard, we can’t proceed,” said Dr Peter Marks, director of the FDA’s Center for Biological Assessment and Research. Marks noted that some of the new data that led the FDA to delay the decision was “last-minute.”
Pfizer and BioNTech 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. Efficacy data were not disclosed.
“This is a three-dose vaccine, and they would present data on the first two doses. It makes sense to wait for safety and efficacy data for all three doses to be available before we make a decision on this vaccine,” Dr. Paul said. Offit of Children’s Hospital of Philadelphia.
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