The US Food and Drug Administration is postponing an advisory panel meeting on authorizing Pfizer’s Covid-19 vaccine in children under 5.
The US Food and Drug Administration announced Friday that it is postponing the meeting of its Vaccines and Related Biological Products Advisory Committee, originally scheduled for February 15, as"new data have recently emerged" regarding Pfizer and BioNTech's emergency use authorization request for their Covid-19 vaccine for children younger than 5.
"This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines. We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company's ongoing clinical trial and have an opportunity to complete an updated evaluation," acting FDA Commissioner Dr. Janet Woodcock and Dr.
Read MorePfizer said the study's independent Data Monitoring Committee supports the continuation of the trial. It believes that the data collected indicates that the vaccine is well-tolerated and supports a potential three-dose regimen. This is a developing story and will be updated.
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