FACACLASSIC

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HHS - 1041 - Vaccines and Related Biological Products Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Vaccines and Related Biological Products Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	1041
Original Establishment Date	12/31/1979	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	16
Terminated This FY	No	Designated Fed Officer Position Title*	Designated Federal Officer, DSAC, Center for Biologics Evaluation and Research, FDA
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	12/31/2023	Designated Federal Officer First Name*	Cicely
Date Of Renewal Charter	12/31/2025	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Reese
Exempt From Renewal*	No	Designated Federal Officer Suffix	Pharm.D.
Specific Termination Authority		Designated Federal Officer Phone*	301-796-9025
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	cicely.reese@fda.hhs.gov
Effective Date Of Authority*	12/31/1979
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not 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, allergenics, 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, allergy and allergenic diseases, molecular biology, rDNA, virology; bacteriology, parasitology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, hypersensitivity reactions to vaccines, 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 3 meetings in FY25 and estimate that this committee will hold 5 meetings in FY26. 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. 1. October 5, 2023 – The committee met in open session via web conference to discuss the Strain Selection for the Influenza Virus Vaccines for the 2024 Southern Hemisphere Influenza Season. Agency Action: February 14, 2024, FDA approved Fluzone Quadrivalent, southern hemisphere and Fluzone Quadrivalent High-Dose southern hemisphere for the 2024 southern hemisphere influenza season. 2. March 5, 2024 – The committee met in open session via web conference to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2024-2025 Northern Hemisphere Influenza Season. Agency Action: On July 1, 2024, FDA approved 2024-2025 Unites States Formulation of Influenza vaccines for the 2024-2025 northern hemisphere influenza season. 3. June 5, 2024 (May 16, 2024), the committee met in open session to discuss and make recommendations on the selection of the 2024-2025 Formula for COVID-19 vaccines. Agency Actions: On August 22, 2024, FDA had four regulatory actions [approval/authorizations] on COVID-19 vaccines. COVID-19 Vaccines (2024-2025 Formula) Approval of Supplements to Biological License Applications: • Spikevax (COVID-19 Vaccine, mRNA) STN 125752/220 – Strain change to 2024-2025 Formula for use as a single dose in individuals 12 years of age and older • Comirnaty (COVID-19 Vaccine, mRNA) STN 125742/564 – Strain change to 2024-2025 Formula for use as a single dose in individuals 12 years of age and older Authorization of Amendments to the Emergency Use Authorizations: • EUA 27034, Pfizer-BioNTech COVID-19 Vaccine - Use of Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) in individuals 6 months through 11 years of age. • EUA 27034, Moderna COVID-19 Vaccine - Use of Moderna COVID-19 Vaccine (2024-2025 Formula) in individuals 6 months through 11 years of age. August 30, 2024 Authorization of Amendments to the Emergency Use Authorizations: • EUA 28237, Novavax COVID-19 Vaccine, Adjuvanted COVID-19 Vaccine - Use of Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) in individuals 12 years of age and older. 4. September 20, 2024-Topic I, the committee will meet in open session to discuss considerations related to the use of pertussis controlled human infection models [CHIMs] in clinical development of new pertussis vaccines. Topic II, the committee will meet in open session to hear an overview of the research programs of the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR). Agency Action: The Agency is discussing next steps following VRBPAC recommendations.
Why advice can't be obtained elsewhere?*	Members of the Committee are drawn from academia, research, and/or clinical practice. They provide advice and input that FDA considers as part of its regulatory decision-making process. 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?	There was one closed meeting to report for FY2025. The meeting was closed in accordance with 21 CFR section 14.27 (b), implementing 5 USC 552b(c)6), for the review of matters that would constitute a clearly unwarranted invasion of personal privacy if disclosed.
Recommendation Remarks

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	No
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve a new medical product or other regulatory decision-making.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	NA	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The 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 Comment	NA
Number Of Recommendations*	143	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made approximately 143 recommendations from FY2003 through FY2024.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The 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 Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The 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 Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	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.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:36 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Emergency Emergency Preparedness and Management Food and Drugs Food and Drugs Health Treatment Medicine Diseases

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