Forbes - Vaccine delay for kids under 5

Plus: Canadian Covid-19 vaccine mandate protest convoy raises $8.7 million

The FDA is giving the parents of kids aged 6 months to under 5 years old whiplash. After previously asking Pfizer and BioNTech to speed up its data submission to support authorization of a two-dose vaccine for young kids, the federal agency is now pumping the breaks and canceled an advisory committee scheduled for February 15. “At this time we believe additional information regarding the ongoing evaluation of a third dose should be considered,” Peter Marks, director of the FDA Center for Biologics Evaluation and Research, told reporters this afternoon. In a statement, the companies said they expected to have data on the three-dose regimen available in early April.

When asked if scheduling and canceling the FDA advisory committee meeting might fuel concerns about the agency’s process and generate more hesitancy, Marks said he hoped parents would instead be reassured. “We have set a standard by which we feel if something does not meet that standard, we can’t proceed forward,” he said, declining to go into specifics. In December, Pfizer and BioNTech had said two doses didn’t generate a strong enough immune response in kids 2 to under 5 years old. 

So what should parents of young children who are unable to be vaccinated do in the meantime? “Parents will have to rely on what they’ve come to do well,” said Marks. “They’re using masking procedures and they’re making sure they’re vaccinated and taking those kind of precautions with their youngest children.”

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