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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.


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 Year2019Committee 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 Date12/31/2017Designated Fed Officer Position Title*Center for Biologics Evaluation and Research, FDA
Date Of Renewal Charter12/31/2019Designated Federal Officer PrefixCAPT
Projected Termination Date Designated Federal Officer First Name*Serina
Exempt From Renewal*NoDesignated Federal Officer Middle NameA
Specific Termination AuthorityDesignated Federal Officer Last Name*Hunter-Thomas
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixM.S.A., R.N.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*240-402-5771
Effective Date Of Authority*12/31/1979Designated Federal Officer Fax*301-595-1307
Exempt From EO 13875 Discretionary CmteExempt: Consumer Product Safety CmteDesignated Federal Officer Email*serina.hunter-thomas@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 Committee 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?*In FY-19 the Committee held 4 meetings (two open, and two partially closed) were held in FY 2019. The Committee receives information regarding the scope and mission of the research programs from the Office of Vaccines Research and Review. All discussions are related to components of the Strategic Plan and FDA's Critical Path to New Medical Products.

October 3, 2018 – The Committee met by teleconference in open session to discuss and make recommendations on the strain selection for the 2019 Southern Hemisphere Influenza season. Agency Action: In February 2019, CBER/OVRR approved a strain change supplement for a licensed influenza vaccine to include the influenza vaccine strains recommended by the VRBPAC Committee in 2019 southern hemisphere influenza vaccine formulation.

November 8, 2018 – The Committee met in open session to hear updates of the research program in the Laboratory of DNA Viruses (LDV), Division of Viral Products (DVP), Office of Vaccine Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Agency Action: The research programs of the Laboratory of DNA Viruses in the Division of Viral Products continue to provide information, approaches, and assays that facilitate the introduction of new vaccines against infectious diseases. These diseases are both current, such as seasonal influenza viruses, but are also against emerging infectious viruses such as Zika virus, Chikungunya virus, Middle East respiratory syndrome coronavirus, and Nipah virus among others. In addition, the research programs address potential concerns with vaccine safety.

March 6-7, 2019 - The Committee met in open session for Topic I: To discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2019-2020 influenza season. Under Topic II: Presentation of the Laboratory of Retroviruses (LR) and Laboratory of Immunoregulation (LIR), Division of Viral Products (DVP), Office of Vaccine Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). Under Topic III: The committee met in open session to discuss and make recommendations on the safety and effectiveness of Dengue Tetravalent Vaccine (Live, Attenuated) [Dengvaxia] manufactured by Sanofi Pasteur. Agency Action (Topic I): In July 2019, CBER/OVRR will approve strain change supplements for licensed influenza vaccines to include the influenza vaccine strains recommended by the VRBPAC Committee in the 2019-2020 influenza vaccine formulation. Agency Action (Topic II): The research programs of the Laboratory of Retroviruses continue to be pursued to understand the safety and effectiveness of vaccines against influenza, RSV, Zika, Ebola, and HIV with emphasis on humoral responses against key membrane proteins and novel adjuvants as well as novel cell substrates. The goals of the Unit on Viral Immunology and Pathogenesis is to develop new and improved technologies for comprehensive evaluation of the humoral immune responses and effectiveness of novel vaccines against viral diseases, and to decipher the added value of adjuvants. Also, development of in vitro assays based on human cells that could help in screening of novel adjuvants and help to predict their safety in vivo. The Unit of Molecular Retrovirology is focused on improving safety of vaccine cell substrates through new technologies for detecting novel adventitious (unwanted) viruses, including exogenously introduced and endogenously expressed viruses that could pose a potential risk for human infection and potentially raise public health concerns. The Unit is also developing in vitro models to investigate simian foamy virus infection in humans and also continues to work with a NHP model for investigating foamy virus natural infection. The research programs of the Laboratory of Immunoregulation in the Division of Viral Products study the generation, characterization, and immunogenicity of viral protein antigens to aid the review of the safety, purity, and immunogenicity of viral vaccines. Projects investigate how viral surface proteins initiate viral infection and the antibody responses that protect against infection and disease. Viral vaccine platforms being investigated include recombinant proteins and particles, nucleic acids, and replicating viral vectors for enhancing immune responses, with a focus on HIV and influenza antigens. Assays to measure immune responses to vaccine antigens are also being developed and used to develop correlates of protection. This research provides the reviewers with the necessary expertise for providing expert technical evaluation of data in FDA submissions for viral vaccines and allows reviewers to interact with vaccine manufacturers to facilitate the development of safe and effective viral vaccines. Agency Action (Topic III): The recommendations made by VRBPAC are being considered in the Agency’s decision regarding approval of Dengue Tetravalent Vaccine (Live, Attenuated) (DENGVAXIA) manufactured by Sanofi Pasteur.

March 22, 2019 – The Committee met in an open session via teleconference to discuss and make recommendations on the H3N2 Strain Selection for the Influenza Vaccines for the 2019 – 2020 Influenza Season. Agency Action: In July 2019, CBER/OVRR will approve strain change supplements for licensed influenza vaccines to include the H3N2 influenza strain recommended by the VRBPAC Committee in to the 2019 – 2020 influenza vaccine formulation.

For FY 2020, 4 open meetings and 1 partially closed meeting are planned.
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?Two of the four 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*105Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made approximately 105 recommendations from FY2003 through FY2019. See 20a of the Annual Report for specific accomplishments.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.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$22,838.00Est Payments to Non-Fed Members Next FY*$171,665.00
Payments to Federal Members*$9,562.00Est. Payments to Fed Members Next FY*$44,159.00
Payments to Federal Staff*$461,946.00Estimated Payments to Federal Staff*$302,017.00
Payments to Consultants*$3,987.00Est. Payments to Consultants Next FY*$77,165.00
Travel Reimb. For Non-Federal Members*$10,893.00Est Travel Reimb Non-Fed Members nextFY*$31,088.00
Travel Reimb. For Federal Members*$2,489.00Est Travel Reimb For Fed Members*$2,508.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$7,366.00Est Travel Reimb to Consultants Next FY*$19,229.00
Other Costs$119,412.00Est. Other Costs Next FY*$79,470.00
Total Costs$638,493.00Est. Total Next FY*$727,301.00
Federal Staff Support (FTE)*2.75Est. Fed Staff Support Next FY*1.90
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-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