Novartis fast production, cell-culture flu vaccine OK'd by FDA
The FDA today gave Novartis ($NVS) the go-ahead for a seasonal flu vaccine that is made from animal cell culture instead of chicken eggs, a process that can turn out vaccine pronto in the event of a pandemic.
Novartis says the technology, which is used with some other kinds of vaccines, can produce product within weeks instead of the months it can take to grow it in chicken eggs. The Swiss company will use a cell-culture system derived from the kidney of a dog, The Wall Street Journal said. This will shave about four weeks off the process compared to using eggs and eliminates the need to keep a stock of eggs.
"Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way," said Andrin Oswald, who heads the Novartis vaccines and diagnostics division.
According to the FDA, a study found Flucelvax 83.8% effective in preventing influenza when compared to a placebo. It is approved for those who are at least 18 years old. Novartis told The Wall Street Journal a limited amount of the vaccine would be available for this year's flu season.
The vaccine will be moved to Novartis' Holly Springs, NC, plant when it is approved for production. Novartis is building the plant with about $500 million in support from the U.S. government. Novartis and other companies are getting U.S. funds for vaccine production with the agreement that if a pandemic should occur, the U.S. could say how much of what vaccines would be produced. Novartis says the joint investment in the technology and plant is about $1 billion. It said the use of sterile rooms in the plant will also reduce the risk of impurities getting into the vaccine.
While the FDA was touting the new vaccine process in the U.S., in the U.K. there is a debate raging over the effectiveness of the seasonal flu vaccine campaign, The Telegraph reports. It focuses on a report from the Center for Infectious Disease Research & Policy (CIDRAP) in Minneapolis, MN, that says national campaigns that convince citizens that flu vaccines are "highly effective" has kept better vaccines from being developed. Michael Osterholm, CIDRAP director, says he recommends vaccination, "But we have over-promoted this vaccine. For certain age groups in some years, its effectiveness has been severely limited relative to what has been previously reported."
- read the Wall Street Journal story (sub. req.)
- here's the Novartis release
- and here's the FDA announcement
- read The Telegraph story
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