The U.S. government awarded Sanofi $226 million to expand its state-of-the-art flu vaccine manufacturing facilities as part of the nation's ongoing effort to move production away from the 70-year-old antiquated process of using chicken eggs and better prepare for the next big pandemic.
The company markets Flublok, the only quadrivalent recombinant protein-based seasonal influenza vaccine approved by the U.S. Food and Drug Administration.
Flublok is an exact copy of the influenza virus coat protein and is not subject to the egg-adapted mutations associated with low vaccine effectiveness, Sanofi said.
NIAID Director Anthony Fauci
The company obtained the vaccine when it acquired Protein Sciences Inc. in 2017.
The vaccine is produced using baculovirus technology in cells from the Spodoptera frugiperda, or the fall armyworm, a caterpillar.
Using modern cell culture technology allows for quicker production of large quantities of hemagglutinin, the protein identified as key to stimulating immunity to influenza, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.
At a Dec. 4 Capitol Hill hearing, Fauci and other U.S. flu experts urged Congress, the administration and the biopharmaceutical industry to invest more in novel vaccine manufacturing technologies and to expand their facilities in the U.S.
Robert Kadlec, assistant secretary of preparedness and response at the U.S. Department of Health and Human Services, revealed to lawmakers that his agency planned to do just that, though he did not disclose the details at that time.
Fauci has said recombinant DNA technologies would be the tool for getting to a universal flu vaccine — a product that could provide robust, long-lasting protection against multiple subtypes of influenza, rather than a select few.
The six-year $226 million HHS contract is intended to help Sanofi expand and retain its recombinant vaccine manufacturing capacity to produce Flublok in the U.S.
The funds under the public-private partnership between the company's vaccine unit, Sanofi Pasteur, and HHS' Biomedical Advanced Research and Development Authority, or BARDA, are expected to used to help the manufacturer retrofit its facilities in Swiftwater, Pa.
The agreement includes an option for an additional facility at the Swiftwater site to be retrofitted to produce adjuvant, an ingredient that helps vaccines work better. In addition, the contract includes options for the development and licensure of an adjuvanted, recombinant pandemic influenza vaccine and give HHS access to the vaccine production capacity for up to 25 years after the manufacturing facilities are completed.
Sanofi is expected to double its recombinant protein-based influenza vaccine manufacturing capacity in the U.S. under the contract, HHS said.
The agency estimated the company could provide nearly 100 million doses of recombinant influenza vaccine for use during a pandemic.
David Loew, executive vice president of vaccines at Sanofi, noted his company has a longstanding relationship with BARDA and said it is committed to advancing its influenza vaccine technology and manufacturing in the U.S.
The contract is part of a broader U.S. initiative to build on ongoing efforts to make a better flu vaccine.
Making technologies that quickly and safely produce effective influenza vaccines is fundamental to responding to an influenza outbreak, including a pandemic, BARDA Director Rick Bright said in a Dec. 9 statement.
Keeping vaccine manufacturing in the U.S. is also essential, he said.
The question is not if, but when the next influenza pandemic will occur, "carrying potentially devastating consequences for public health and the U.S. economy," Bright said. "Better, faster vaccine technologies produced in the U.S. will improve access, protect more people and ultimately strengthen our nation's health security."