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  4. Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement - 10/14/2021 - 10/15/2021
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Advisory Committee Meeting

Event Title
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Announcement
October 14 - 15, 2021

Scheduled

Date:
October 14 - 15, 2021
Day1:
- ET
Day2:
- ET

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: 

  • Day 1

 

  • Day 2

 

Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Under Topic 1, the committee will meet in open session to discuss the Emergency Use Authorization (EUA) of the ModernaTX Inc. COVID-19 vaccine for the administration of an additional dose, or “booster” dose, following completion of the primary series, to individuals 18 years of age and older. On October 15, 2021, under Topic II, the committee will meet in open session to discuss the Emergency Use Authorization (EUA) of the Janssen Biotech Inc. COVID-19 vaccine for the administration of an additional dose, or “booster” dose, to individuals 18 years of age and older.

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, 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-2021-N-0965.

The docket will close on October 13, 2021. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 13, 2021. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before October 12, 2021, will be provided to the committee. Comments received after October 12, 2021, and by October 13, 2021, will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications, submissions, 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-2021-N-0965 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 Kathleen Hayes, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 240-818-7798, 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.

On October 14, 2021, oral presentations from the public will be scheduled between approximately 12:45 p.m. Eastern Time and 1:45 p.m. Eastern Time and approximately between 11 a.m. and 12 noon Eastern Time on October 15, 2021.

Those individuals interested in making formal oral presentations should notify CBERVRBPAC@fda.hhs.gov and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before 6 p.m. on October 8, 2021.

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 October 12, 2021.

Webcast Information
CBER plans to provide a free of charge a 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. 

The online web conference meeting will be available at the following links listed above.

Contact Information

  • Prabhakara Atreya or Kathleen Hayes: 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.

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.

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 Organization
Vaccines and Related Biological Products Advisory Committee Meeting October 14-15, 2021 Briefing Document Addendum - Sponsor pdf (310.15 KB) Non-FDA
Vaccines and Related Biological Products Advisory Committee Meeting October 14, 2021 Draft Agenda pdf (77.91 KB) FDA
Vaccines and Related Biological Products Advisory Committee Meeting October 15, 2021 Draft Agenda pdf (105.02 KB) FDA
Vaccines and Related Biological Products Advisory Committee Meeting October 14-15, 2021 Briefing Document - Sponsor (Moderna) pdf (899.54 KB) Non-FDA
Vaccines and Related Biological Products Advisory Committee Meeting October 14-15, 2021 Briefing Document - Sponsor (Janssen) pdf (6.47 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Draft Roster pdf (203.44 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Briefing Document - Sponsor Errata pdf (96.75 KB) Non-FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Briefing Document - FDA (Moderna) pdf (853.38 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Waiver to Allow Participation - James Hildreth pdf (104.06 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Acknowledgement of Financial Interests- James Hildreth pdf (67.82 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Briefing Document - FDA (Janssen) pdf (871.51 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14-15, 2021 Meeting Overview Document pdf (81.08 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting Presentation - Booster Protection Across Ages -Data From Israel pdf (1.94 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting Presentation - FDA Review of Effectiveness and Safety of ​Moderna COVID-19 Vaccine ​(mRNA-1273) Booster Dose Emergency Use Authorization Amendment pdf (4.09 MB) FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting Presentation - Moderna COVID-19 Vaccine Application for Emergency Use Authorization of a Booster Dose pdf (603.22 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting Presentation - Safety and Immunogenicity of a 50 µg Booster Dose of mRNA-1273 (Moderna COVID-19 Vaccine) pdf (1.14 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting Presentation - Surveillance Updates of Myocarditis/Pericarditis and mRNA COVID-19 Vaccination in the FDA BEST System pdf (880.37 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting - Discussion Question pdf (46.59 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting - Voting Question pdf (48.61 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 14, 2021 Meeting Presentation - Welcome Remarks by Dr. Peter Marks pdf (421.36 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting Presentation - DMID 21-0012 - Heterologous Platform Boost Study - Mix and Match pdf (3.62 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting Presentation - Emergency Use Authorization (EUA) Amendment for a Booster Dose for the Janssen COVID-19 Vaccine (Ad26.COV2.S) pdf (1.88 MB) Non-FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting Presentation - FDA Review of Effectiveness and Safety of ​Janssen COVID-19 Vaccine ​(Ad26.COV2.S) Booster Dose Emergency Use Authorization Amendment pdf (3.56 MB) FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting Presentation - Janssen COVID-19 Vaccine Application for Emergency Use Authorization of a Booster Dose pdf (555.94 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting Presentation - Review of Post Authorization Safety Data for Janssen COVID-19 Vaccine pdf (599.85 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting Presentation - Review of RWE to Assess the Effectiveness of a Single Dose of Janssen COVID-19 Vaccine (Ad26.COV2.S) pdf (502.82 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting - Voting Question pdf (43.27 KB) FDA
Vaccines and Related Biological Products Advisory Committee October 15, 2021 Meeting - Discussion Question pdf (40.71 KB) FDA

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