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Pfizer on fast track to getting its vaccine for under-fives ...

World

Pfizer on fast track to getting its vaccine for under-fives approved

Cases among children reached a record high in the US in December, leading to earlier than expected FDA submission

Josh Wingrove and Riley Griffin

Pfizer and partner BioNTech say they have started submitting data to US regulators for authorisation of their Covid-19 vaccine for younger children, hastening an effort to get shots to more of them after the Omicron wave caused paediatric infections to jump.

The companies said they have started a rolling submission with the US Food and Drug Administration (FDA) seeking an emergency authorisation for the vaccine in children aged six months to four years. A panel of outside advisers is scheduled to meet on February 15 to consider the request, according to the agency.  

“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data,” acting commissioner Janet Woodcock said. ..

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