Where the Science Jobs Are - Winter 2009

H1N1: A shot in the arm for the pharmaceutical industry

During the past year, the H1N1 virus tragically claimed an estimated 4,000 lives within the United States, as well as 7,820 abroad. In response, earlier this year, the Centers for Disease Control suggested that thousands of Americans should receive vaccinations. However, to date, only one-third of those Americans have actually received their vaccinations.

The recent shortage of H1N1 vaccinations in the United States has highlighted the need for novel, more dependable vaccine development technologies. The national government is currently investigating more efficient manufacturing methods, including cell culture, in order to expedite vaccine production. As of now, the only FDA approved method for growing viral material for H1N1 vaccines is through the usage of chicken eggs. However, a cell culture method would significantly reduce production time, thereby showing that the traditional chicken egg method may no longer be the best option.

Meanwhile, although various companies have complained about receiving little profit from flu vaccines in the past, global demand and governmental subsidies are currently helping the business become more appealing.

Here are a few examples:

• The Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism has recently asked the national government to begin spending $3 billion a year on the production of vaccines and medications, in order to improve their efficiencies.
• In 2009, the National Institute of Allergy and Infectious Diseases will spend $262 million on influenza research, including research on a new generation of vaccines that can be created without growing a virus.
• The Department of Health and Human Services recently awarded a $35 million contract to Protein Sciences Corporation of Meriden, Connecticut to develop a novel flu vaccine that does not depend on growing a virus. Rather, the vaccine inserts genetic material from a flu virus into another virus that infects insect cells. The infected insect cells then produce proteins that are used to create a vaccine for humans.
• Backed by $487 million in federal funding, Novartis has initiated construction on the first large-scale cell-culture manufacturing plant in the United States, located in Holly Springs, North Carolina. The Novartis plant will not only produce flu vaccines in dog kidney cells, but will also have the capacity to manufacture 50 million doses of seasonal flu vaccines and 150 million doses of pandemic vaccines for the United States within six months of the declaration of a pandemic.
• Baxter has also expressed interest in building a cell-based vaccine manufacturing plant in the United States in order to produce seasonal and pandemic flu vaccines. Timing of the plant’s construction will depend on the outcome of a government-funded clinical trial of its cell-based product. Baxter also produces H1N1 vaccines for Europe, where the cell-based method is approved.
• Finally, European vaccine makers are expected to realize substantial fourth quarter sales from H1N1 vaccines: GSK estimates $1.7 billion in the fourth quarter, with similar numbers anticipated for the first quarter 2010. In the meantime, Novartis expects $700 million in fourth-quarter sales while Sanofi-Aventis anticipates $500 million in sales revenue.

Vaccines have historically been deemed as low priorities within the pharmaceutical industry. However, as chartbuster drugs become harder to obtain and impending generic competition on a number of current products increases, drug makers will continue to build various vaccine plants. As the national government becomes more willing to subsidize such endeavors, the United States may indeed witness resurgence in vaccine research and manufacturing in the near future.