It seems like you can’t turn around these days without seeing another vaccine story on the wires. Novartis has announced its cell culture vaccine technology has successfully passed its clinical trials and is preparing for regulatory approvals. Instead ofusing eggs to grow the vaccine seed strain, Novartis is using dog kidney cells which are permissive for influenza virus growth. By-passing eggs allows freedom from a precarious pathogen-free egg supply and faster start-up time from when the pandemic strain is identified. Novartis says it has successfully scaled up production methods and plans “to be the first to market with this product.” (Bloomberg)
This all sounds good (and it would be great if we weren’t under such time pressure), but the details show this stuff isn’t just around the corner:
Because it’s not limited by the number of available eggs, the cell-based method can be scaled up more quickly than the traditional method. Novartis said the North Carolina plant could produce as many as 50 million shots against seasonal flu by 2011, and up to 150 million shots for pandemic flu.
The company also is investing in its Marburg, Germany, site to expand European capacity for flu vaccines using the cell- culture technique.
U.S. health officials want to develop the ability to make at least 300 million doses of vaccine against a pandemic strain within six months of an outbreak. (Bloomberg)
So the US wants 300 millioin doeses and Noovartis thinks they might be able to produce 150 million from their US plant in 2011. ‘Nuff said.
Which brings me to another announcement. AP is reporting that the biotech company Viacal has announced successful experiments on ferrets for their H5N1 DNA vaccine (see this post for more on DNA vaccines). The important part of this trial is that they needed only a single dose:
Vical Inc., a developer of gene-based therapies, on Friday said a trial of its single dose avian influenza DNA vaccine candidate provided 100 percent protection in ferrets against a lethal strain of bird flu.
The San Diego-based company said previous studies have shown that two doses of the vaccine candidate provided total protection in mice and ferrets against the H5N1 avian influenza virus, commonly known as bird flu.
Vical said its DNA vaccine candidate uses two influenza virus proteins plus the H5 avian influenza virus surface protein and is formulated with the company’s patented Vaxfectin adjuvant, a sort of catalyst.
The company hopes to begin human testing as soon as possible. (AP)
This sounds like good news, too. If you go to the Vical Press Release, however, you will also find this:
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether results in mouse and ferret studies will be predictive of results in human studies; whether Vical or others will continue development of the pandemic influenza DNA vaccine candidate; whether H5N1 or other strains of avian flu will emerge as pandemic threats; whether the company’s DNA vaccine candidate will be effective in protecting humans against H5N1 or other strains of avian flu; whether development of an avian flu vaccine would lead to development of a seasonal flu vaccine; whether the flu vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market the flu vaccine or any other product candidates; whether Vical or its collaborative partners will succeed in marketing the flu vaccine or any other product candidates; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements. (PRNewswire)
‘Nuff said. Again.