Nursing News:
Protein Sciences to expand testing of new þu vaccine

By Julie Schmit
While the USA heads into flu season with a shortage of vaccine, a handful of companies are pushing ahead to develop a potentially faster way to make them. Thursday, Protein Sciences, a small, Connecticut-based biotech company, said it had received the Food and Drug Administration¹s approval to conduct advanced testing of its cell-culture flu vaccine in 500 people in the USA, ages 18 to 49. The company¹s vaccine is made in cell cultures instead of eggs. That difference could shorten the typical six- to eight-month production time required to make egg-based injected flu vaccine.
If Protein Sciences¹ trial is successful, more testing will likely occur next year, says Chief Operating Officer Manon Cox. The company hopes to have a vaccine for the U.S. market by 2007, she says. While 2007 might prove too optimistic for the privately owned, 38-employee firm, it might not be for some bigger companies. The best-case scenario is that cell-based flu vaccine will be available in the USA in two or three years, says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health.
There are several advantages to cell-based manufacturing. Faster production would strengthen national defenses against an unexpected flu strain. People who are allergic to eggs, who cannot take today¹s egg-based vaccines, could take the new ones.
Economics has been a barrier to developing cell-based flu vaccine, says David Webster, industry consultant with the Webster Consulting Group. The current process, though it relies on millions of eggs, ³is cheap,² and the U.S. flu vaccine market hasn¹t been big enough to support big, new investments. Other vaccines, such as ones for polio and rabies, already are grown in cell cultures. Flu vaccine experts, including Webster, expect the current shortage to increase interest in new flu vaccines.
Who will be first to market is the question. Aventis Pasteur, the company supplying nearly all of the USA¹s flu vaccine this year, partnered with European biotech firm Crucell to develop a cell-based flu vaccine. Next month, they will announce a more detailed timeline for the testing that precedes FDA approval, says Crucell spokesman Thomas Redington.
Solvay Pharmaceuticals, also based in Europe, has a cell-based flu vaccine that is licensed but not marketed there. It is building a manufacturing plant and considering options for the U.S. market, the company says. Chiron and Baxter International are also investing in cell-based flu vaccines. Chiron was supposed to supply almost half of the USA¹s flu vaccine this year until British authorities quarantined its vaccine because of contamination. Another company pursuing cell-based flu vaccines is Canada¹s ID Biomedical, which supplies more than 75% of flu vaccine to the Canadian market. Last month, it announced that it had been awarded a $9.5 million federal grant to develop its cell-culture flu vaccine.
Reprinted USA TODAY 2004