FDA Committee Delays Review of Pfizer-BioNTech ’s COVID-19 Vaccine for Young Kids

The U.S. Food and Drug Administration (FDA) postponed a meeting to discuss the authorization of Pfizer-BioNTech’s COVID-19 vaccine for children younger than five, again pushing back the timeline for vaccinating the youngest Americans. The FDA’s Vaccines and Related Biological Products Advisory Committee was scheduled to meet on Feb. 15 to discuss emergency use authorization of a two-dose regimen of Pfizer-BioNTech’s vaccine formulated for children ages 6 months through 4 years. (Pfizer is testing a three-microgram dose for young kids, smaller than the doses offered to adults and older children.) But on Feb. 11, the FDA announced that Pfizer had notified the agency of new data from its ongoing clinical trial testing a three-dose regimen for kids, necessitating a longer review period. [time-brightcove not-tgx=”true”] “FDA and Pfizer want completed studies on the three-dose product before reviewing the data,” Dr. Paul Offit, director of Children’s Hospital of Philadelphia’s Vaccine Education Center and a member of the FDA’s vaccine advisory committee, wrote in an email to TIME. The delay “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,” the FDA said in a statement. The FDA did not announce a new date for the advisory committee meeting, but Pfizer and BioNTech said in a press...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 healthscienceclimate Source Type: news