The Department of Health and Human Services chief Kathleen Sebelius said HHS would pay privately-owned Protein Sciences a minimum of $35 million to develop its recombinant (DNA) influenza vaccine for the swine flu pandemic, which may hit this fall.
The company is in late stage trials for a seasonal flu vaccine called Flublok. it plans to be making a swine flu vaccine in five weeks at its pilot production plant, CEO Daniel Adams has said.
Tiny Protein Sciences, Meriden, CT, which is now hiring scientists, joins the ranks of vaccine makers Sanofi-Pasteur, Glaxo and Novartis, which are making seasonal and swine flu vaccines for the government.
These manufacturers still grow vaccine in egg cells, a 50-year old process that takes about five months. Novartis has produced some swine flu vaccine using a mammalian cell-based technique that insiders say is not as productive as DNA technology, although Novartis' approach shaves time off the hen-based method.
Known as recombinant influenza vaccine, the technique Protein Science uses involves extracting a gene from a flu virus and placing it into an insect virus called baculovirus, whose DNA can be quickly cloned.
In addition to ramping up commercial production faster than the egg-growing (or mammalian cell methods), the cloning technology also allows cells to be frozen and stored indefinitely, HHS says.
If Protein Sciences' technology pans out, the contract with HHS could be extended up to five years at a total cost of approximately $147 million, HHS says.
"The technology has advanced in recent years to a point that we believe [DNA-based technology] could help meet a surge in demand for vaccine for seasonal and pandemic flu," Secretary Sebelius said. "We want to use the technology to help our nation respond to emerging infectious diseases."
HHS notes, "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 ...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."
Read DOTmed's coverage of this important topic:
Novartis First to Make H1N1 Vaccine Using New Cell Technology
WHO Declares Swine Flu Pandemic
Flu Slowing in Most Parts of U.S; Vaccine Makers Get $1 Billion
Swine Flu Virus Update--Where We Stand and How We Got Here
Delicate Balance of Life on Earth Revealed in Current Flu Spread
CDC Must Decide Whether to Ramp up New Flu Vaccine
Race to Find a Flu Vaccine Is On; Flu Remedies Profit
All Bets Are on Drug Stocks; Government Has Ample Supply