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Administration for Strategic Preparedness and Response
10/4/24
The Administration for Strategic Preparedness and Response’s (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) is providing approximately $72 million to CSL Seqirus, Sanofi, and GSK to complete the next steps in influenza A(H5) vaccine manufacturing as part of national preparedness.
“This announcement is an illustration of the work we do at ASPR everyday to help the country prepare for and respond to disease outbreaks,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “These awards ensure the country has access to additional pandemic influenza vaccines should they be needed now or in the future.”
Under existing agreements, CSL Seqirus, Sanofi, and GSK will fill and finish additional doses of their influenza A(H5) vaccines from bulk storage into ready-to-use vials or pre-filled syringes so that vaccine will be ready to distribute if needed. The companies also will manufacture additional bulk influenza antigen - the component of vaccines that stimulates an immune response - from seed stocks that are well matched to circulating strains.
In addition, Sanofi will preserve a continuous domestic egg supply so that the company is ready to manufacture egg-based influenza vaccine, such as H5 influenza vaccine, at any time of the year. BARDA has worked with Sanofi since 2006 to ensure the ongoing capability to produce egg-based pandemic influenza vaccines year-round.
“Although the risk to Americans from influenza A(H5) virus infection remains low, we’re leaning forward with our preparedness efforts,” said BARDA Director and Deputy Assistant Secretary for Preparedness and Response Gary Disbrow, Ph.D. “As influenza A(H5) virus infections in domesticated animals continue to spread, the risk for human infection could rise. In an abundance of caution, we are taking steps to increase the amount of vaccine that could be immediately available if needed.”
These preparedness activities began in 2022 as soon as the first H5N1 influenza case was identified in Colorado. The steps announced today further strengthen and sustain the nation’s preparedness should vaccine be needed for any future influenza-related public health emergency.
Commonly called ‘bird flu,’ high pathogenicity avian influenza (HPAI) viruses cause serious illness and fatalities in domestic poultry and other wild birds and can spread to other species, as currently seen in U.S. dairy cattle. Recent influenza A(H5) infections in dairy farm workers and poultry workers in the U.S. have resulted in mild illness without spreading through the household or community.
Separately, BARDA is providing $121.4 million to CSL Seqirus for general pandemic influenza preparedness and vendor managed inventory (VMI) of additional adjuvant of the company’s H5 influenza vaccine. Adjuvant is used in some vaccines to help create a stronger immune response for people receiving the vaccine and can allow vaccines to be made with less antigen to aid in protecting more people in an influenza pandemic.
Since inception in 2006, BARDA has partnered with influenza vaccine manufacturers to support pandemic influenza preparedness and domestic rapid response capabilities.
BARDA also oversees the U.S. National Pre-pandemic Influenza Vaccine Stockpile (NPIVS), created in 2005 as part of the Influenza & Emerging Infectious Diseases - Pandemic Vaccines and Adjuvants Program. Through this program, BARDA constantly monitors epidemiological data to assess risk and rapidly evaluate, refine, and update vaccine preparedness inventories.
The awards announced today are part of the BARDA’s Pandemic Vaccines and Adjuvants medical countermeasure portfolio and support the ASPR/BARDA Pandemic Influenza Preparedness and Response Strategy and the National Pandemic Strategy.
10/4/24
The Administration for Strategic Preparedness and Response’s (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) is providing approximately $72 million to CSL Seqirus, Sanofi, and GSK to complete the next steps in influenza A(H5) vaccine manufacturing as part of national preparedness.
“This announcement is an illustration of the work we do at ASPR everyday to help the country prepare for and respond to disease outbreaks,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “These awards ensure the country has access to additional pandemic influenza vaccines should they be needed now or in the future.”
Under existing agreements, CSL Seqirus, Sanofi, and GSK will fill and finish additional doses of their influenza A(H5) vaccines from bulk storage into ready-to-use vials or pre-filled syringes so that vaccine will be ready to distribute if needed. The companies also will manufacture additional bulk influenza antigen - the component of vaccines that stimulates an immune response - from seed stocks that are well matched to circulating strains.
In addition, Sanofi will preserve a continuous domestic egg supply so that the company is ready to manufacture egg-based influenza vaccine, such as H5 influenza vaccine, at any time of the year. BARDA has worked with Sanofi since 2006 to ensure the ongoing capability to produce egg-based pandemic influenza vaccines year-round.
“Although the risk to Americans from influenza A(H5) virus infection remains low, we’re leaning forward with our preparedness efforts,” said BARDA Director and Deputy Assistant Secretary for Preparedness and Response Gary Disbrow, Ph.D. “As influenza A(H5) virus infections in domesticated animals continue to spread, the risk for human infection could rise. In an abundance of caution, we are taking steps to increase the amount of vaccine that could be immediately available if needed.”
These preparedness activities began in 2022 as soon as the first H5N1 influenza case was identified in Colorado. The steps announced today further strengthen and sustain the nation’s preparedness should vaccine be needed for any future influenza-related public health emergency.
Commonly called ‘bird flu,’ high pathogenicity avian influenza (HPAI) viruses cause serious illness and fatalities in domestic poultry and other wild birds and can spread to other species, as currently seen in U.S. dairy cattle. Recent influenza A(H5) infections in dairy farm workers and poultry workers in the U.S. have resulted in mild illness without spreading through the household or community.
Separately, BARDA is providing $121.4 million to CSL Seqirus for general pandemic influenza preparedness and vendor managed inventory (VMI) of additional adjuvant of the company’s H5 influenza vaccine. Adjuvant is used in some vaccines to help create a stronger immune response for people receiving the vaccine and can allow vaccines to be made with less antigen to aid in protecting more people in an influenza pandemic.
Since inception in 2006, BARDA has partnered with influenza vaccine manufacturers to support pandemic influenza preparedness and domestic rapid response capabilities.
BARDA also oversees the U.S. National Pre-pandemic Influenza Vaccine Stockpile (NPIVS), created in 2005 as part of the Influenza & Emerging Infectious Diseases - Pandemic Vaccines and Adjuvants Program. Through this program, BARDA constantly monitors epidemiological data to assess risk and rapidly evaluate, refine, and update vaccine preparedness inventories.
The awards announced today are part of the BARDA’s Pandemic Vaccines and Adjuvants medical countermeasure portfolio and support the ASPR/BARDA Pandemic Influenza Preparedness and Response Strategy and the National Pandemic Strategy.
