A US decision on a Pfizer and BioNTech Covid-19 vaccine for children ages 6 months to 4 years was delayed for at least two months after the Food and Drug Administration (FDA), equivalent to Anvisa, said that needed more data.
The FDA planned 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 increase 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’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 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 come up with 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,” said Paul Offit of Children’s Hospital of Philadelphia.
Source: CNN Brasil
