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VRBPAC Meeting on Pfizer’s ABRYSVO Respiratory Syncytial Virus Vaccine
May 18, 2023 @ 8:30 am - 5:30 pm EDT
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement
On 18 May 2023, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), manufactured by Pfizer Inc., with a requested indication, in Biologics License Application (BLA) 125768 (STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.
Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, “Advisory Committees Give FDA Critical Advice and the Public a Voice,” for more information.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Additional materials will be posted on FDA’s website after the meeting.
Materials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page.
The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting.
The Docket Number is FDA-2023-N-1338
Comments received on or before May 11, 2023, will be provided to the committee. Comments received after May 11, 2023, and by May 17, 2023, will be taken into consideration by FDA. In the event the meeting is canceled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
Please visit the VRBPAC Meeting Announcement page for more information.