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Advisory Committee Meeting | Virtual

Event Title
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Announcement
May 18, 2023

Scheduled

Date:
May 18, 2023
Time:
8:30 AM - 5:30 PM ET

What is an advisory committee?

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.

Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.

The online web conference meeting will be available at the following: 

Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On May 18, 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.

*Note: Correction Notice Published – April 19, 2023 – The document was published with the incorrect docket number. This document corrects that error.

In the Federal Register of Tuesday, April 11, 2023 (88 FR 21688) in FR Doc. 2023-248, the following corrections are made:

On page 21688, in the third column, in the header of the document, “Docket No. FDA-2023-N-0378” is corrected to read “Docket No. FDA-2023-N-1338” and in the ADDRESSES section, in the third line of the last paragraph, “FDA-2023-N-0378” is corrected to read “FDA-2023-N-1338.” 

On page 21689, in the first column, in the second line of the “Instructions:” section, Docket No. FDA-2023-N-0378” is corrected to read “Docket No. FDA-2023-N-1338”.

Meeting Materials
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

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2023-N-1338. The docket will close on May 17, 2023. Either electronic or written comments on this public meeting must be submitted by May 17, 2023. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of May 17, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.

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.

You may submit comments as follows:

Electronic Submissions

  • Federal eRulemaking Portal: https://www.regulations.gov Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

  • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2023-N-1338 for “Vaccines and Related Biological Products Advisory Committee (VRBPAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

Confidential Submissions-- To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf 

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Valerie Vashio or Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 240-506-4946, CBERVRBPAC@fda.hhs.gov or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at the Advisory Committee Calendar and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

ORAL PRESENTATIONS: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) 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. Oral presentations from the public will be scheduled approximately between 1:15 p.m. and 2:15 p.m. Eastern Time on May 18, 2023. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present; the names, email addresses, and direct contact phone numbers of proposed participants, on or before 6 p.m. Eastern Time on May 3, 2023. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by 6 p.m. Eastern Time on May 5, 2023.

Webcast Information
CBER plans to provide a free of charge live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. 

If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Contact Information

  • Valerie Vashio or Prabhakara Atreya CBERVRBPAC@fda.hhs.gov
  • FDA Advisory Committee Information Line: 
    1-800-741-8138 (301-443-0572 in the Washington, DC area)
    Please call the Information Line for up-to-date information on this meeting.
  • For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

Official FR Notice
Correction FR Notice


A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


Event Materials

Title File Type/Size Source Organization
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Waivers for Conflicts of Interest pdf (76.74 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document- FDA pdf (942.99 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document- Pfizer pdf (3.00 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Draft Agenda pdf (148.58 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Voting Questions pdf (117.53 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Draft Roster pdf (299.40 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Presentation- Bivalent RSV Prefusion F Vaccine for Maternal Immunization to Protect Infants pdf (2.14 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Presentation- Biologics License Application for Respiratory Syncytial Virus Vaccine (ABRYSVO) pdf (199.36 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Presentation- Clinical Considerations of RSV in infants from birth through 6 months of age pdf (1.32 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Presentation- Review of Efficacy and Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO) pdf (1.62 MB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Presentation- RSV Epidemiology and Disease Burden in Infants from Birth through 6 Months of Age pdf (967.73 KB) Non-FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Presentation- RSV virology, strain variation, and surveillance measures pdf (3.59 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Final Agenda pdf (144.61 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Final Roster pdf (291.83 KB)
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Transcript pdf (930.44 KB) FDA
Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Summary Minutes pdf (174.39 KB) FDA

 
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