HHS has awarded a five-year $97 million contract aimed at streamlining production of U.S. influenza vaccine supplies -- a move heartily welcomed by one family physician infectious disease expert.
The award to sanofi pasteur will support development of human cell-based, rather than chicken egg-based, technology for producing flu vaccine. The contract with HHS also calls on sanofi pasteur to devise plans to establish a U.S.-based manufacturing facility to produce the new cell culture vaccine.
"This action begins the process of speeding up influenza vaccine production, improving surge capacity and scaling up U.S. manufacturing capability," Secretary Michael Leavitt said in an April 1 HHS news release on the deal with sanofi pasteur. "As a result, this should allow the U.S. to have influenza vaccines in a more timely, less laborious manner, and it provides another tool for responding to and controlling a global influenza pandemic."
The current method of producing vaccine takes almost nine months to complete. After scientists select the flu virus strains they anticipate will be the predominant circulating strains for a given flu season, they have to adapt those strains to grow in fertilized chicken eggs and then incubate the eggs -- millions of them -- to produce sufficient quantities of virus. The strains are then combined into a single vaccine product.
Using a cell-culture approach to producing flu vaccine would obviate the need to adapt the strains for implantation and incubation in chicken eggs. The new technique would permit rapid response to a surge in demand for vaccine, such as might be seen during a flu pandemic, because the cells could be frozen in advance and thawed as needed to produce large quantities of vaccine in a relatively short time.
In addition, said the HHS news release, using a cell-based production method would allay fears about risks associated with the egg-based route, such as how poultry diseases or an agricultural terrorism event could affect to the flu vaccine supply. And finally, patients would no longer have to forgo vaccination because of allergies to eggs.
"Probably the most important aspect of this is that we are finally talking about expanding the production of vaccine," said FP Jonathan Temte, M.D., Ph.D., of Madison, Wis. Temte is associate professor of family medicine at the University of Wisconsin, Madison, and an infectious disease researcher who has served on a CDC working group on pandemic influenza. He also is a member of the AAFP Commission on Clinical Policies and Research.
Given that chicken embryo-based production has remained the standard for decades, Temte noted, "this is a quantum leap and may allow a more responsive system."
That becomes particularly important, he added, when dealing with an illness such as avian influenza. Because the pathogen responsible for producing that disease preferentially preys on chickens -- rapidly killing off its host -- "you can't grow it in eggs very well."
As for the other points HHS raised: "Whereas egg allergy is a small factor, it does cause problems," Temte said.
Overall, however, Temte applauded the move. "A more rapid and efficient system of production can ensure a more dependable supply of vaccine in the future," he said.
