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          Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement - 06/14/2022Advisory Committee Calendar Advisory Committee Meeting
    Event Title
              Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement


                  June 14 - 15, 2022

  Scheduled

    
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      Meeting Information
                Event MaterialsDate:
            
  


     
                                                       
       

June 14 - 15, 2022   

 
         
                    
                                              Day1: 
                Tue, Jun 14 8:30 AM
 - 5:00 PM
 ET
              
                          Day2: 
                Wed, Jun 15 8:30 AM
 - 5:00 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.    


 
**6/14/2022 - Day 1** 

	Youtube: https://youtu.be/GbNpaZeDPiA**6/15/2022 - Day 2**

	Youtube: https://youtu.be/Ixm4UmldTGQ


**Day 1**

**Day 2**



**Agenda**
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will meet in open session to discuss the following: On June 14, 2022, under Topic 1, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age. On June 15, 2022, under Topic II, the committee will meet in open session to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age..

**Meeting Materials**
FDA 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, any background material will be made publicly available at the time of the advisory committee meeting, and 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-2022-N-0904

FDA is establishing a docket for public comment on this meeting.  The docket number is FDA-2022-N-0904.  The docket will close on June 13, 2022. Submit either electronic or written comments on this public meeting by June 13, 2022. 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. ET at the end of June 13, 2022.  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 June 7, 2022, will be provided to the committee. Comments received after June 7, 2022, and by June 13, 2022, will be taken into consideration by FDA. In the event that the meeting is cancelled, 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-2022-N-0904 for “Vaccines and Related Biological Products; 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:** Prabhakara Atreya or Sussan Paydar, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 240-506-4946, or via email at 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 Agency’s website at https://www.fda.gov/advisory-committees and scroll down to the appropriate advisory committee meeting link or call the advisory committee information line to learn about possible modifications before joining the meeting.

**SUPPLEMENTARY INFORMATION:** Consistent with FDA’s regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to the need for prompt discussion on Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine to include the administration of a primary series to infants, children, and adolescents 6 months through 17 years of age, and also to amend the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of a primary series to infants and children 6 months through 4 years of age.

**BACKGROUND 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 at the at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. 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.

**PROCEDURE:** On June 14-15, 2022, from 8:30 a.m. to 5 p.m. ET, the meeting is open to the public. 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 June 7, 2022, will be provided to the committee. Comments received after June 7, 2022, and by June 13, 2022, will be taken into consideration by FDA.

**ORAL PRESENTATIONS:** Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. ET. 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 and email addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before 6 p.m. ET on June 8, 2022. 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 June 10, 2022.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

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 Prabhakara Atreya or Sussan Paydar (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website for procedures on public conduct during advisory committee meetings.

**Webcast Information**
CBER plans to provide a free of charge a live webcast of the Vaccines and Related Biological Products Advisory Committee meeting https://youtu.be/GbNpaZeDPiA and https://youtu.be/Ixm4UmldTGQ. 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**

Prabhakara Atreya (240-506-4946) or Sussan Paydar: 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.Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

**Official 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 OrganizationVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting- James Hildreth- Acknowledgment of Financial Interest
              pdf               (187.36 KB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting- James Hildreth- Waiver to Allow Participation
              pdf               (274.38 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Draft Agenda
              pdf               (285.25 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Draft Roster
              pdf               (350.96 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Draft Roster
              pdf               (329.05 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document - Sponsor (Moderna)
              pdf               (4.99 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document- FDA- COVID19 Moderna Vaccine For Use in Pediatrics
              pdf               (2.43 MB)
              FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Draft Agenda- Revised
              pdf               (306.14 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Voting Question- Moderna
              pdf               (86.32 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Voting Question- Moderna
              pdf               (111.66 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document- Sponsor- Pfizer- COVID19 Vaccine for Pediatrics
              pdf               (1.35 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Voting Question- Pfizer
              pdf               (120.28 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document- FDA- Pfizer- COVID19 Vaccine for Pediatrics
              pdf               (902.21 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Voting Question- Pfizer- Revised
              pdf               (121.44 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Presentation- COVID19- epidemiology in children and adolescents ages 6 months - 17 years
              pdf               (2.12 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Presentation- COVID19- Safety Surveillance of Vaccines in Children and Adolescents
              pdf               (872.63 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14,2022 Meeting Presentation- COVID-19 vaccine coverage and effectiveness during Omicron for children and adolescents
              pdf               (1.80 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Presentation- FDA- Moderna COVID19 Vaccine for 6-17 Years
              pdf               (617.39 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Presentation- Sponsor- Moderna COVID19 Vaccine for 6-17 Years
              pdf               (1.78 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Presentation- Update on myocarditis following mRNA COVID-19 vaccination
              pdf               (2.69 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Briefing Document- Sponsor- Pfizer- COVID19 Vaccine for Pediatrics- Addendum
              pdf               (1.94 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Presentation- COVID19- FDA Review of Effectiveness and Safety of Moderna Vaccines in 6mo to 5yr
              pdf               (888.52 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Presentation- COVID19- FDA Review of Effectiveness and Safety of Pfizer Vaccines in 6mo to 4yr
              pdf               (1,016.50 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Presentation- COVID19 Intorduction Vaccine for 6mo-5yr
              pdf               (612.08 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Presentation- Sponsor- Moderna COVID19 Vaccine for 6mo-5yr
              pdf               (1.90 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Presentation- Sponsor- Pfizer COVID19 Vaccine for 6mo-4yr
              pdf               (1.18 MB)
              Non-FDAVaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Final Agenda
              pdf               (243.46 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Final Roster
              pdf               (370.22 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Final Roster
              pdf               (225.78 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Summary Minutes
              pdf               (243.16 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Summary Minutes
              pdf               (236.50 KB)
              FDAVaccines and Related Biological Products Advisory Committee June 15, 2022 Meeting Transcript
              pdf               (2.06 MB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Transcript
              pdf               (2.08 MB)
              FDAVaccines and Related Biological Products Advisory Committee June 14, 2022 Meeting Presentation- COVID19- FDA Review of Effectiveness and Safety of Moderna Vaccines in Children and Adolescents
              pdf               (722.84 KB)
              FDA

                                                                                  Content current as of:
      08/19/2022
         
                   
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  VaccinesHealth Topic(s)
			  CoronavirusBack to Advisory
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