FDA Advisory Committees - FDA Center for Biologics Evaluation and Research (CBER) - Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Upcoming Meetings
On Thursday May 16, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines.
Past Meetings
On March 5, 2024, the Vaccines and Related Biological Products Advisory Committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee [VRBPAC] meeting for October 5, 2023. During the meeting, the committee will discuss the Strain Selection for the Influenza Virus Vaccines for the 2024 Southern Hemisphere Influenza Season.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on June 15th 2023, to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Thursday May 18, 2023. The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), submitted by Pfizer, with a requested indication, in Biologics License Application (BLA-125768) STN 125768/0), for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals.
On March 7, 2023, the VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2023--2024 influenza season.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Wednesday March 1, 2023. The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of AREXVY (Respiratory Syncytial Virus Vaccine, Recombinant, Adjuvanted), manufactured by GSK, with a requested indication, in BLA 125775 (STN 125775/0), for active immunization for the prevention of LRTD caused by respiratory syncytial virus RSV-A and RSV-B subtypes in adults 60 years of age and older.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Tuesday February 28, 2023. The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine), submitted by Pfizer, with a requested indication, in Biologics License Application (BLA) 125769 (STN 125769/0), for active immunization for the prevention of acute respiratory disease and lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Thursday, Jan 26th, 2023, to discuss the future vaccination regimens addressing COVID-19.
The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on October 06, 2022, to discuss the Strain Selection for the Influenza Virus Vaccines for the 2023 Southern Hemisphere Influenza Season.
The US FDA has scheduled an Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for Thursday, September 22, 2022 to discuss a Biologics License Application (BLA - 125739) for Rebyota (Fecal Microbiota, Live), with a requested indication to reduce the recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI infection.
The USFDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Tuesday, June 28, 2022 to discuss whether and how the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified.
The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Wednesday 15, June 2022. The committee will meet in open session to discuss an Emergency Use Authorization (EUA) request made by Moderna for a COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age.
The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Tuesday 14, June 2022. The committee will meet in open session to discuss an Emergency Use Authorization (EUA) request made by Moderna for a COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age.
The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Tuesday 07, June 2022. The committee will meet in open session to discuss an Emergency Use Authorization (EUA) request by submitted by Novavax for a COVID-2019 vaccine (NVX-CoV2373) to prevent COVID-19 infections in individuals 18 years of age and older.
The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on March 03, 2022 to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for influenza season of 2022 – 2023 influenza season.
The US FDA on February 15, 2022 has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss a request to amend the Emergency Use Authorization (EUA) of the Pfizer-BioNTech’s COVID-19 mRNA vaccine for administration to children 6 months through 4 years of age.
The committee will meet discuss Pfizer Inc.’s request to amend its Emergency Use Authorization (EUA) to allow for the use of the Pfizer-BioNTech COVID-19 vaccine in children 5 through 11 years of age.
On October 14, 2021, the committee will discuss the proposed Emergency Use Authorization (EUA) of the Moderna COVID-19 mRNA vaccine for the administration of a booster dose, following completion of the primary series, to individuals 18 years of age and older. On October 15, 2021,, the committee will discuss the proposed EUA of the Janssen Biotech Inc. COVID-19 vaccine for the administration of a booster dose, to individuals 18 years of age and older.
The committee will discuss the Pfizer-BioNTech application for a booster shot of its mRNA COVID-19 in individuals 16 years of age and older.
The committee will provide a status update on its approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
The Committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2021 – 2022 influenza season
The committee will discuss the proposed 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.
The committee will 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.
The committee will 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.
On March 4, 2020, under Topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.
The committee will discuss and make recommendations on the development of chikungunya vaccines.
On October 9, 2019, under topic I, the Center for Biologics Evaluation and Research’s (CBER) VRBPAC will meet in open session to hear an overview of the research programs in the Laboratory of Hepatitis Viruses (LIR) and the Laboratory of Vector-Borne Viral Diseases (LVVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA. Also, on October 9, 2019, under topic II, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2020 southern hemisphere influenza season.
OOn March 22, 2019, in follow-up to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019-2020 seasonal influenza vaccines, the Center for Biologics Evaluation and Research reconvened the VRBPAC to discuss and make recommendations specifically on the H3N2 strain. The VRBPAC previously met on March 6, 2019, and made recommendations on the selection of all other strains to be included in seasonal influenza virus vaccines for the 2019-2020 influenza season. The committee unainimously agreed (10 of 10 members) with the WHO’s recommendation.
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
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 product for which the Food and Drug Administration has regulatory responsibility.
The committee will make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.