The U.S. Department of Health and Human services announced recently that the Food and Drug Administration has approved a new seasonal flu vaccine that promises to make responding to a flu pandemic faster.
“The process is nimble enough to be used for seasonal as well as potentially for pandemic flu vaccine because the technology does not depend on an egg supply or on the availability of modified influenza virus for production like traditional egg-based vaccine manufacturing does,” according to a statement issued by Nicole Lurie, HHS assistant secretary for preparedness and response (ASPR).
Calling it “a landmark in influenza vaccine history,” Lurie credited the breakthrough to a public-private partnership between ASPR’s Biomedical Advanced Research and Development Authority (BARDA) and the Protein Sciences Corporation of Meriden, Conn., the makers of “Flublok,” as it is currently branded.
Flublok consists of a protein, hemagglutinin, from the virus. Putting the gene for hemagglutinin into a virus that infects insect cells makes the protein. Those cells, from the fall armyworm, are grown in culture and churn out the protein. Neither eggs nor the live virus are used.
The armyworm, so called because of its habit of infesting and destroying crops the way army ants do, except that Spodoptera frugiperda morphs into a moth that has less consequence for farmers in North American than in Africa or Asia. Its cells are commonly used in biomedical research for recombinant protein expression using insect-specific viruses called baculoviruses. This binary protein expression system has many desirable characteristics and is widely used for vaccines for other diseases.
According to the New York Times, Protein Sciences, a privately held company, first applied for approval nearly five years ago. It was turned down twice, in part because of the novelty of using insect cells.
“Every time, we were asked to do more and more studies to prove that this cell substrate was safe,” Ms. Cox told the Times.
The company was close to bankruptcy in 2009 when it received a federal contract worth tens of millions of dollars to help develop its vaccine.
Lurie said BARDA has been working with the vaccine industry since 2006 to develop faster, more versatile ways of meeting the demand for flu vaccines. Production typically lags a year behind supplies because vaccine manufacturers need such a long start-up period for new vaccines. They base production goals on orders received the year before. Because vaccines have to target new strains of flu each year, any surplus production from the current year cannot be held over for the next year. Overestimating the amount of vaccine needed in a given year is a costly business decision for a company to make and they make only as much as they have orders for. When pandemics occur, such as we are experiencing this year and in the past, health officials are faced with rationing limited supplies for the most vulnerable, such as the very young, the very old and people with compromised immune systems.
“This new way of making flu vaccine is an example of the Obama administration partnering with industry to move innovative technology forward to the market,” said Lurie. “Our goal in ASPR is to drive innovative development of effective and cost-efficient vaccines, drugs, diagnostics and medical equipment to protect public health during emergencies.”