The U.S. Department of Health and Human Services (HHS) issued a six-year, $226 million contract today to increase capacity to produce recombinant influenza vaccine in the United States. The contract is in accordance with the September 19, 2019 presidential executive order to enhance national security and the public health by modernizing influenza vaccines and technologies.
The work will take place through a public-private partnership between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and Sanofi Pasteur, a global pharmaceutical company with U.S. headquarters in Bridgewater, NJ.
“Influenza viruses can spread rapidly around the globe, infecting hundreds of millions of people in just weeks, making technologies that quickly and safely produce effective influenza vaccines fundamental in responding to an influenza outbreak,” said BARDA Director Rick Bright, Ph.D. “Keeping vaccine manufacturing in the United States is essential to protect Americans from pandemic influenza and to save lives. Better, faster vaccine technologies, produced in the U.S. will improve access, protect more people and, ultimately, strengthen our nation’s health security.”
Recombinant vaccine technology can produce new vaccines faster than traditional egg-based technology. Currently, Sanofi Pasteur is the only company with a seasonal recombinant influenza vaccine licensed in the United States and with the resources to leverage this technology for pandemic influenza preparedness.
To expand and retain domestic recombinant influenza vaccine capacity, Sanofi Pasteur will retrofit vaccine manufacturing facilities in Swiftwater, Pennsylvania. When the project is completed, it will double Sanofi’s recombinant protein-based influenza vaccine manufacturing capacity in the United States. The agreement with Sanofi Pasteur includes options for an additional facility at this site to be retrofitted to produce adjuvant; development and licensure of an adjuvanted, recombinant pandemic influenza vaccine; and HHS access to the vaccine production capacity for up to 25 years after the manufacturing facilities are completed. As a result of this agreement, Sanofi Pasteur could provide nearly 100 million doses of recombinant influenza vaccine for use during a pandemic.
An adjuvant is an ingredient used in some vaccines to help create a stronger immune response in people receiving the vaccine, meaning that adjuvant helps vaccines work better. Vaccines containing adjuvants are tested for safety and effectiveness in clinical trials before they are licensed for use in the United States, and when approved, they are continuously monitored by the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention.
About HHS, ASPR, and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, devices, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Since 2007, 52 BARDA-supported products have achieved regulatory approval, licensure or clearance. For more about ASPR and BARDA, visit here and to learn more about partnering with BARDA, please visit here.