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Committee Detail

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”


HHS - 1041 - Vaccines and Related Biological Products Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameVaccines and Related Biological Products Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number1041
Original Establishment Date12/31/1979Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*16
Current Charter Date12/31/2021Designated Fed Officer Position Title*Director, DSAC, Center for Biologics Evaluation and Research, FDA
Date Of Renewal Charter12/31/2023Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Prabhakara
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Atreya
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPh.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(240) 402-8006
Effective Date Of Authority*12/31/1979Designated Federal Officer Fax*
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*prabhakara.atreya@fda.hhs.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot Applicable
How does cmte accomplish its purpose?*The Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are experts in immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. One member is technically qualified and identified with consumer interests and one non-voting member represents the point of view of industry.
How frequent & relevant are cmte mtgs?*The committee held 9 meetings in FY21 and estimate that this committee will hold 10 meetings in FY22.

The Committee receives information regarding the scope and mission of the research programs from the Office of Vaccines Research and Review (OVRR). All discussions are related to components of the Strategic Plan and FDA's Critical Path to New Medical Products.
October 2, 2020 – The committee met in open session via web conference to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020-2021 southern hemisphere influenza season.

Agency Action: CBER/OVRR approved strain change supplements for licensed influenza vaccines to include the influenza vaccine strains recommended by the VRBPAC Committee in the 2020-2021 influenza vaccine formulation.

October 22, 2020 – The committee met in open session via web conference to discuss the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application was discussed at this meeting.

Agency Action: OVRR considered VRBPAC’s recommendations for safety and effectiveness data to support emergency use authorization of COVID-19 vaccines, including time of median follow-up for safety and effectiveness and the need for additional studies to further evaluate safety and effectiveness after EUA issuance.

December 10, 2020 – The Committee met in open session via web conference to discuss emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

Agency Action: On December 11, 2020, the FDA issued an EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.

December 17, 2020 - The committee met in open session via web conference to discuss emergency use authorization (EUA) of the Moderna COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.

Agency Action: On December 18, the FDA issued an EUA for the Moderna COVID-19 vaccine for the prevention of COVID-19 in individuals 18 years of age and older.

February 26, 2021 – The committee met in an open session via web conference to discuss emergency use authorization (EUA) of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older.

Agency Action: On February 27, the FDA issued an EUA for the Janssen Biotech Inc. COVID-19 Vaccine for the prevention of COVID-19 in individuals 18 years of age and older.

March 5, 2021 – The committee met in open session via web conference to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 – 2022 northern hemisphere influenza season.

Agency Action: CBER/OVRR approved strain change supplements for licensed influenza vaccines to include the influenza vaccine strains recommended by the VRBPAC Committee in the 2021-2022 influenza vaccine formulation.

June 10, 2021 – The committee met in open session via web conference to discuss data needed to support authorization and/or licensure of COVID-19 vaccines for use in pediatric populations.

Agency Action: The FDA will consider the recommendations of VRBPAC in authorizing vaccines for pediatric populations, such as studies to further characterize vaccine-induced adverse events and post-authorization/post-licensure studies to further evaluate safety and effectiveness.

September 17, 2021 - The Committee met in open session to discuss the Pfizer-BioNTech supplemental Biologics License Application for COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older.

Agency Action: The FDA will consider the recommendations of VRBPAC in authorizing booster doses for the appropriate age groups, for individuals 65 years of age and older, and those at high risk of occupational exposure to COVID-19.

September 30. 2021 - The Committee met in open session to hear an overview of the research programs in the Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) and, under Topic II, to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022 southern hemisphere influenza season.

Agency Action: Agency Action (Topic I): The Laboratory of Bacterial Polysaccharides (LBP), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) will continue its research on the characterization of polysaccharide conjugate vaccines. This research will inform the regulatory evaluation of vaccines submitted by manufacturers.

Agency Action (Topic II): CBER/OVRR approved strain change supplements for licensed influenza vaccines to include the influenza vaccine strains recommended by the VRBPAC Committee in the 2021-2022 influenza vaccine formulation.
Why advice can't be obtained elsewhere?*Members of the committee are drawn from academia, research, and/or clinical practice. Their advice and input lends credibility to regulatory decisions made and helps those decisions stand up to intense public scrutiny. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensation.
Why close or partially close meetings?One of the nine meetings were partially closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).
Recommendation RemarksNo reports are required for this committee.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesYes
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve a new medical products.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Vaccines and Related Biological Products Advisory Committee enables the Agency to obtain required and frequently scarce professional services from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of the public health for which it is difficult to assign a financial value.Grants Review CommentNA
Number Of Recommendations*118Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made approximately 118 recommendations from FY2003 through FY2021.Access Agency WebsiteYes
% of Recs Fully Implemented*84.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access GSA FACA WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*The Agency usually does. Product approval issues are first released to the sponsor. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters issues are available publicly when implemented.Narrative Description*FDA's strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tabacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Vaccines and Related Biological Products Advisory Committee supports FDA's mission and strategic action plan by reviewing and evaluating available data relating to the safety and effectiveness of vaccines and related biological products, which are intended for, use in the prevention, treatment, or diagnosis of human diseases. The Committee also considers the quality and relevance of FDA's research programs which provides scientific support for the regulation of these products. The Committee supports FDA's mission by using science-based efficient risk management in all of its activities. The Committee recommendations provide the most health promotion and protection at the least cost for the public. This Committee assists the Agency in ensuring timely, high quality, cost-effective processes for review of new technologies/pre-market submissions, effective communication and working relationships with stakeholders to enhance U.S. and global health outcomes, accurately analyzing risks associated with medical products, facilitating the development and availability of medical countermeasures to limit the effects of a terrorist attack on the civilian and military populations, protecting the safety and security of biologics, especially vaccines, all key components of FDA's strategic plan objectives.
The committee estimates to hold 10 meetings in FY22.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Date Cost Last Modified4/18/2022 2:21 PMEst. Fed Staff Support Next FY* 
Federal Staff Support (FTE)* Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Category
Area
Emergency
Emergency Preparedness and Management
Food and Drugs
Food and Drugs
Health
Treatment
Medicine
Diseases
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-040259Vaccines and Related Biological Products Advisory Committee2021
 COM-038534Vaccines and Related Biological Products Advisory Committee2020
 COM-036406Vaccines and Related Biological Products Advisory Committee2019
 COM-034610Vaccines and Related Biological Products Advisory Committee2018
 COM-002056Vaccines and Related Biological Products Advisory Committee2017
 COM-002567Vaccines and Related Biological Products Advisory Committee2016
 COM-004074Vaccines and Related Biological Products Advisory Committee2015
 COM-004451Vaccines and Related Biological Products Advisory Committee2014
 COM-006260Vaccines and Related Biological Products Advisory Committee2013
 COM-006564Vaccines and Related Biological Products Advisory Committee2012
 COM-008342Vaccines and Related Biological Products Advisory Committee2011
 COM-008887Vaccines and Related Biological Products Advisory Committee2010
 COM-010340Vaccines and Related Biological Products Advisory Committee2009
 COM-010852Vaccines and Related Biological Products Advisory Committee2008
 COM-011882Vaccines and Related Biological Products Advisory Committee2007
 COM-012593Vaccines and Related Biological Products Advisory Committee2006
 COM-014054Vaccines and Related Biological Products Advisory Committee2005
 COM-014782Vaccines and Related Biological Products Advisory Committee2004
 COM-015901Vaccines and Related Biological Products Advisory Committee2003
 COM-016793Vaccines and Related Biological Products Advisory Committee2002
 COM-017781Vaccines and Related Biological Products Advisory Committee2001
 COM-018506Vaccines and Related Biological Products Advisory Committee2000
 COM-019703Vaccines and Related Biological Products Advisory Committee1999
 COM-020312Vaccines and Related Biological Products Advisory Committee1998
 COM-021727Vaccines and Related Biological Products Advisory Committee1997