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Committee Detail

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
Committee Type*ContinuingDesignated Federal Officer Email*serina.hunter-thomas@fda.hhs.gov
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?*October 4, 2017 – The Committee met in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2018 southern hemisphere influenza season.Agency Action: The recommendations made by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) were considered in the Agency’s decision regarding regulatory actions on influenza vaccine strains to include in the 2017-2018 formulation for the southern hemisphere influenza season. November 7, 2017 - The Committee met in open session to discuss and make recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations.Agency Action: The FDA considered the advice of the committee regarding Pfizer’s Staphylococcus aureus vaccine in future communications with the sponsor regarding their clinical development plan. March 1, 2018, Topic I, the Committee met in open session to hear an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, FDA. Topic II, the Committee met in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 influenza season. Agency Action: In July 2018, CBER/OVRR approved strain change supplements for licensed influenza vaccines to include in the 2018-2019 formulation for the northern hemisphere influenza season recommended by the VRBPAC Committee. May 17, 2018, Topic I, the Committee met in open session to discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. Topic II, the Committee met in open session to hear an overview of the research program in the Laboratory of Respiratory Viral Diseases, Division of Viral Products, Office of Vaccines Research and Review. Agency Action: Recommendations made during this meeting informed regulatory considerations and dialogue with sponsors regarding ongoing clinical development of GBS vaccines.
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?*Four meetings (two open, and two partially closed) were held in FY 2018. 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. For FY 2019, 5 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?N/A
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 ResourcesNo
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 product.
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*100Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made approximately 100 recommendations from FY2003 through FY2018. See 20a of the Annual Report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%Access Committee WebsiteNo
% 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*20.00%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 CommentThe 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* 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
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
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

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 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
 COM-034610Vaccines and Related Biological Products Advisory Committee2018