(WKBN) – Just as California Governor Gavin Newsom announced Friday a vaccine mandate for students in K-12, the FDA said it will meet to discuss Pfizer’s expected request to approve its vaccine for kids.
The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on Oct. 26 to inform the agency’s decision-making.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Acting FDA Commissioner Dr. Janet Woodcock.
On Oct. 14, the committee will discuss an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.
On Oct. 15, the VRBPAC will discuss amending the emergency use authorization of Johnson and Johnson’s Janssen COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.
The FDA intends to live stream the VRBPAC meetings on the agency’s YouTube page (Oct. 14 meeting link; Oct. 15 meeting link; Oct. 26 meeting link), which will be viewable on the agency’s Facebook and Twitter channels; the meetings will also be webcast from the FDA website.