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.
"whether the flu vaccine or any other product candidates will be shown to be safe and effective;"...
...how does the old saying go...'do no harm'.
All statements by a publicly traded company whose stock is listed in the US have an announcement like that attached to them regarding "forward-looking statements." It's the law.
Alex. Thanks, I have read a lot of them.
This must be a very efficient company, I have never read one quite this complete before.
It would be nice to get independent verification of the Vical results. However, if they have a DNA vaccine that truly protects ferrets from H5N1, that is very good news. Under normal circumstances, human safety trials will take years. However, if a very severe pandemic occurs within the next year or two, trials could be speeded up. If the DNA vaccine worked in humans, it would be possible to scale up very rapidly. There is no technology other than DNA vaccines that could produce vaccine quickly enough to have a major effect on the first wave. Since the technology involved in producing DNA vaccines is simple, sufficient vaccine for much of the world's population could be produced quickly.
Maybe not quite a magic bullet, but as close as we are going to get.
We are all of course, extremely happy, for the ferrets, around the world.
However, there is still the possibility, that the mutated Bird Flu Virus, if and when it appears, is changed in such a way, that the stockpiled "New Vaccines" are totally ineffective against the mutated virus.
The huge stockpiles of these "new" vaccines are normally paid for by public funds in most countries, that NEED TO BE SPENT due to political reasons.
A good headline about a "New Vaccine" in the global press, is a great help in lubricating the process of purchase in the corridors of power in most countries.
This is still the case, if the magic words DNA, are attached to the said vaccines.
No one denies that there is a strong possibility, that all of these "new" vaccines could well be totally ineffective against the Real McCoy, that is of course, if the virus does mutate in to a human virus.
I am an investor, in what I believe to be the latest technology, related to the Global Bird Flu Problem and believe that all that we have today, is "the best shot possible" against the mutated virus, if and when it appears.
Please let us not use the term DNA, as a universal panacea, against an enemy that has yet to manifest itself. KC
(I love your modest title).
DNA vaccines predate H5N1. They are called DNA vaccines because, well, they are made out of DNA. This is not a marketing gimmick. It's a simple description of what they are.
My dear Monotone, "We" have been involved in the quest and the funding of Biotechnology and "DNA solutions" since the eighties.
I could be wrong, but I get a feeling from your youthful, "witty" and patronising tone, that you were more interested at that time, in other things.
Not a problem.
I am used to lots of great brains carrying on manual theoretical manipulations of their minds, while we get on with trying to find a real time solution to the problems.
We value our privacy and normally we keep a very low profile and try not to attract the attention of experts in the various fields, such as your self.
However, the world has changed a lot and we may have no choice but to open up a bit, if we are going to be able to add the best possible talent to any of our future projects. Not too happy with that though!
Well, I have no idea what you've just said.
There's nothing mysterious about DNA vaccines. A Google or PubMed search will demonstrate that. I don't work in the field myself, but there's nothing theoretical about them.
As for the rest... uh, go for it.
Studies on ferrets are not what they seem: this announcement only means that the vaccine has a positive effect on mammals.
There is only one source of lab ferrets, and they are all the same gene stock. If you buy one as a pet (not where banned, please) you buy another when it dies and the replacement will have the exact same personality.
If there is a big genetic component to disease response, and in this case there probably is, most or few of the ferrets will die. A 50/50 result is very unlikely.
To answer questions more interesting to sense of my own mortality, we would need multiple genestocks of animals with known medical characteristics. This would be achieved by performing the studies with multiple sets of mice from the various normal healthy genestocks available from lab breeders.
Could those with a solid background please comment on these assertions?
Ground Zero Homeboy,
I'm afraid I don't know much about ferret genetics. I didn't realize they were so inbred. It's hard to believe that they would be as inbred as lab mice, though. In any case, I think ferrets are generally considered a much better model than mice for influenza. There certainly could be a genetic component to susceptibility to influenza, including H5N1. However, I am not aware of any genetic factors that would influence expression of a DNA vaccine. The next step will be to test the DNA vaccine in humans (an outbred species, in most places, anyways ;-) ) and see if they generate an immune response.
If they do, then there is not much better evidence that can be obtained, pre-pandemic. Certainly, that evidence would as good as the evidence for any other H5N1 vaccine.