Novartis cut the ribbon on a new North Carolina vaccines facility to munch fanfare Tuesday. However, products from the plant won't hit the shelves for a couple of years. Furthermore, high-speed techniques that bypass the lengthy process of incubating viruses to make vaccine are years away, according to a Wall Street Journal report.
The new Novartis plant is one element in the U.S. government's attempt to modernize vaccine production. The plant will employ new technology to grow flu viruses in vats of cells derived from dog kidneys--an approach that could shave four to six weeks off the time needed to make each shot when compared with the chicken-egg approach. But the company still must carry out tests on its equipment and the vaccine before it can start mass production. And the WSJ cites warnings from scientists who say that flu viruses that grow slowly in eggs may also grow slowly in cells, meaning production may not be much faster.
It isn't clear how many benefits cell-culture technology will offer. For example, GlaxoSmithKline received a $274 million HHS contract in 2007 to develop cell-culture vaccine and to build manufacturing capacity for it, but in a September interview, the head of the company's vaccine business said the technology is about a decade away from being "mature" enough for use, according to the WSJ article.
Protein Sciences recently appeared before an FDA advisory committee to tout the benefits of its innovative flu vaccine FluBlok, which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells. The committee voted 6-5 that the company hadn't adequately demonstrated the safety of the vaccine.
- read the WSJ article