HHS Announces New Way To Make Flu Vaccine
HHS Secretary Kathleen Sebelius announced that the department will pursue advanced development of new way to make influenza vaccine. The work will be done by Protein Sciences Corporation, Inc., of Meriden, Conn., under a new $35 million contract. The contract could be extended up to five years at a total cost of approximately $147 million.
“The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S.-based vaccine for seasonal and pandemic flu,” Secretary Sebelius said. “We want to use the technology to help our nation respond to emerging infectious diseases.”
With this new technology, known as recombinant influenza vaccine, a gene would be extracted from a flu virus and placed into an insect virus called baculovirus, which does not affect people and can multiply quickly to high levels in insect cells. The cells are purified to become a basic part of a human vaccine.
Using this method, vaccine candidates, clinical investigational lots, and commercial-scale vaccine production may be available faster than by using traditional vaccine production methods. Because the basic cells can be frozen and stored indefinitely, manufacturing large quantities of a vaccine is also faster using this recombinant technology.
The new contract will be administered by the Office of Biomedical Advanced Research and Development Authority (BARDA) within HHS and will support Protein Sciences Corporation, Inc., in advanced development activities needed for potential Food and Drug Administration (FDA) approval to use this new technology for producing flu vaccines.
If this new technology is demonstrated to be safe and effective and the FDA licenses the new technology for flu vaccines, the contract requires the company to establish domestic manufacturing capability to provide a finished vaccine within 12 weeks of pandemic onset and to produce at least 50 million doses of pandemic flu vaccine within six months of pandemic onset.
Today’s award aligns with the National Strategy for Pandemic Influenza Implementation Plan, which calls on HHS to develop and procure medical countermeasures for pandemic influenza or for potentially pandemic strains, such as the recent novel H1N1 flu virus.