fast tracking vaccine licensing by mock-up
Continued from here.
In answer to a question on a different thread, this is about which companies might be making vaccines.
A summary from WHO source gives 28 different clinical trials under way by 13 different companies.
The 2 big ones at the moment as far as I know are Chiron (recently acquired by Novartis) and GSK.
Since there is a wide variation in how far clinical trials have progressed, one way to keep track of which company might be in front would be to look at the EMEA mock-up dossier applications. This is a process of fast-tracking pandemic vaccines in Europe by allowing companies to submit results based on a ‘mock-up’ vaccine, so that as many of the issues as possible can be resolved/approved ahead of a pandemic. This will allow a much faster approval time when a pandemic strain appears.
One point of note: there is an important conceptual difference between the position taken by EMEA (European medicines Agency) and the US FDA. The EMEA views pandemic vaccine as fundamentally different from seasonal flu vaccines requiring new full authorization whereas FDA views it as an extension or variation of seasonal flu vaccines.
On the surface, one might think the EMEA position would pose more obstacles as full authorization is required. However, EMEA’s position allows and requires adjustments to objectives and approaches that are more appropriate to a pandemic than a seasonal vaccine, eg antigen-sparing procedures and the use of adjuvants or novel technology.
This approach takes into consideration the very different requirements and problems during a pandemic than during seasonal flu. This together with the mock-up dossier procedure allows companies to design vaccines specifically for pandemic use that will fulfill entirely different criteria than the seasonal vaccines.
Interesting announcement in the news today:
“Glaxo aims to file bird flu vaccine in October”
Quote from article:
Europe’s biggest drugmaker, which started clinical trials of two experimental vaccines in March, has previously said it expected a protective shot would be ready for manufacture by the end of the year. <snip> Several drugmakers are working to develop vaccines against the H5N1 strain of bird flu, but Glaxo believes it may have an advantage because it is using special adjuvants — additives put into vaccines that boost the immune system.”
InfoLady – at 10:35
“Glaxo aims to file bird flu vaccine in October”
Yes, that seems to be the EMEA mock-up dossier application.
Closed to maintain Forum speed.
I am re-opening this thread so that we can put all discussions of candidate pandemic vaccines on one thread (hopefully).
will we be able to buy some vaccine at a Canadian online pharmacy as we can buy Tamiflu there or can’t it be stored at home ?
Current summary of candidate vaccines that have been discussed on this forum:
anonymous – at 15:33 “will we be able to buy some vaccine at a Canadian online pharmacy as we can buy Tamiflu there or can’t it be stored at home ?”
None of these vaccines are ready for market. Even if they are, the quantities will be so limited that governments are likely to ration them extremely carefully, IMO.
For newbies and anyone else who haven’t read this series, the first part of this series Vaccination Strategies For H5N1 Pandemic contains information on general considerations for pandemic vaccination, which are different from normal vaccination.
Bump so everyone knows I’m trying to consolidate some pandemic vaccine discussions. Thanks
“With the current state of science, vaccines are still the best bet for influenza control.”
I’m sorry, BARDA, http://tinyurl.com/ny4e3 makes vaccines the most dangerous type of influenza control. I know a vaccine is your personal focus, anon_22. I hope you allow yourself the ability to change your choice as BARDA kicks in and hiding vaccine information from the public becomes legal. I encourage all readers to research BARDA and the possible side effects of vaccines. A pandemic is bad enough. We really don’t need unchecked human experiments.
I am against dismantling the Freedom of Information Act and do not trust big Pharma to “do the right thing” as Vioxx and other medical episodes suggest. However, if we are talking about an autism prevalence of 2 to 6 per 1000 when most people get lots of vaccinations or a pandemic that infects 50% and kills 10–50% of those infected, then I think the balance must be towards saving tens of millions of lives in the US and hundreds of millions or billions world wide. I think it is completely legitimate to try to ensure a reasonable degree of safety, but some of the approaches (H5N1 proteins on cold viruses) seem very unlikely to cause major damage as a side-effect. I would not FORCE anyone to get a vaccination, but we need to proceed and try to add to the arrows in our quiver.
INFOMASS,
“if we are talking about an autism prevalence of 2 to 6 per 1000 when most people get lots of vaccinations or a pandemic that infects 50% and kills 10–50% of those infected,”
The public has no idea if those numbers are correct. Currently, there are many professionals who believe the number of serious, long term, reactions to vaccines is much higher. BARDA will simply make the current practice of not reporting or sharing this information legal. Once again, we have no idea what percent of the public has a bad reaction to vaccines. The public has no idea how safe or unsafe a vaccine will be. I suppose that’s the point.
“but we need to proceed and try to add to the arrows in our quiver.” Not at the expense of other, wiser, choices.
Sarah: Can you cite peer reviewed studies which compare the “serious long-term reactions” caused against the reduction in morbidity and mortality that vaccinations help ensure? It is a question of costs and benefits, though you are right that any damage done should be public and not secret. On the other hand, the fact that many schools require vaccinations to prevent outbreaks underlines that vaccinations do not just protect one person but also play a role in “herd immunity.”
“It is a question of costs and benefits, though you are right that any damage done should be public and not secret.”
How can you compare cost and benefits, if you don’t have accurate information (BARDA)?
“cite peer reviewed studies” There are studies. Do a simple google search. There are several medical professionals who suspect “serious long-term reactions”.
“herd immunity” is a fantasy. It’s main objective is keeping vaccine researchers employed. Their “studies” reflect a strong desire to keep their jobs. Nasty, dangerous, circle. Once again, I encourage all readers to do their research. I’m off to the beach. Have a great day everyone!
I would like to comment from a different angle on the subject of vaccines.
1) there have been several studies that have indicated that seasonal flu vaccines have had a less than stellar record…probably due to the fact that the virus is unstable genetically and changes faster than the vaccine can be produced.
2) there have been several attempts to produce H5N1 vaccines already…these attempts have been an obvious failure across the board.
3) we should all remember that just because at some point in the future, you can produce an immune response to a molecule in the vaccine does not mean that the vaccine in any way protects against the virus.
4) there have been examples of vaccines that were not protective because the immune response stimulated had nothing to do with preventing infection.
I remain unconvinced that they will produce a vaccine with other than minimal effects for this coming pandemic.
Tom DVM; The cell culture technique is novel and unproven in practice, but does have the potential to add new proteins and ramp up production quickly, and so MIGHT respond to your point #1, and for that reason MIGHT respond to your point #2. I am not competent to respond to your #3 and #4 with respect to a possible H5N1 vaccine, but the undoubted fact that we might fail does not mean we cannot succeed. If we get through this flu season (a very big IF), it is likely that vaccine production and technology would be in better shape for 2007–08. So, you may well be right that vaccines will not work, but surely it is better to try to produce them on the chance they will have a protective effect? I had been trying in previous posts to have a discussion about costs and possible benefits of a vaccine. Sarah is surely right that secrecy and a government crash program (with no threat of damage suits) that is heavily influenced by drug corporations does not bode well for efficient public health choices. But I am not aware of studies that show the costs of successful vaccines for serious diseases are higher than the costs of averted illness and death. But I am happy to read them if they exist.
INFOMASS, Start with the studies on Autism and vaccines. I happen to believe the studies that see a connection. Then move on to the thousands of other reports, stories and studies that question vaccines and their safety/efficiency.
“Sarah is surely right that secrecy and a government crash program (with no threat of damage suits) that is heavily influenced by drug corporations does not bode well for efficient public health choices.”
“Efficient public health choices”. Efficient? It’s dangerous. Once again, I encourage all readers to research vaccines and long term side-effects. Use Google, etc. The information is out there. It simply has to be uncovered. The public needs to understand how unlikely it is that a vaccine will “save” humanity. The money and energy used to chase this “solution” can be used to develop other tools and infrastructure. This has been discussed here before. Hope you are well Tom DVM.
I would like to point out that I am a different Sarah from this one… I post articles to the news thread. Let me rename myself SarahS (formerly posting as Sarah).
Sarah at 16:38: When the CDC writes, “The weight of evidence indicates that vaccines are not associated with autism” and the National Acadamy of Sciences, Institute of Medicine says that epidemiological evidence does not support the link, YOU have to provide peer reviewed articles and not write, “Google it”! Furthermore, I am asking for a study that WEIGHS costs and benefits of vaccination. Are you suggesting that MMR doesn’t work? Or that polio or smallpox have not been nearly eradicated or eradicated vaccines? It may be that some autism is caused by vaccines and there are certainly other side-effects, but that does not mean the cost/benefit balance is against them, though in some cases it may be. Your responses are those of a true believer, not of a scientist. I am willing to read but not to put on a tin foil hat.
The truth is out there. Sorry INFOMASS. Once again, Google it. Vaccines/danger/long term effects. Very interesting reading. The reports make some people very upset. Too bad. I want my tax dollars to focus on real solutions. Not flawed, protected, false, weak, science. I’m going back to lurker mode. I’m well aware of the climate here. Good luck, public. Google, Google, Google. To be clear, I’ve done a lot more then that. So have many, many, professionals.
Sarah and INFOMASS,
We’ve had discussions about this before. This is a free forum and you are very welcome to share your view of vaccinations pros and cons. However, my intention, which perhaps I did not make clear, was to use this thread to explore specific issues around pandemic vaccine production, efficacy, risk, regulatory process etc. If you want to discuss whether vaccinations in general are a good idea, please use or start a different thread.
In other words, please use this thread for what kind of pandemic vaccine, rather than whether one should vaccinate.
Otherwise, the discussions on this very complex issue of comparing different vaccines will become fragmented and very confusing for those seeking specific information on different vaccines. We’ve been there before. Please let us avoid that again.
Thank you for your co-operation.
From the general vaccination thread
Bronco Bill – at 17:35
Okay…let’s start this off with one question: At this time, August 30, 2006, is there an effective HUMAN vaccine against HPAI H5N1 infection? Yes, or No.
Many discussions seem to waver of course, not just on FW, but on many other boards about whether or not there is, there may be, there isn’t, or there cannot be, a vaccine available.
BBB,
At this time, there are various vaccines that have successfully produced antibody responses in human trials. The degree of response varies, but a few have had enough seroconversion to fulfill FDA or European regulatory criteria for seasonal vaccine efficacy.
However, antibody response is only one indicator of immunogenicity, although the experience from seasonal flu vaccine is that there is quite good correlation between antibody to HA and protection.
The only way to know whether a vaccine is effective against H5N1 is really to expose someone to the virus and see if they are protected. Since this is ethically inappropriate, currently we have no data whatsoever proving exactly how much seroconversion would be sufficient to be protective and therefore which one of these vaccines being investigated will work. Many distinguished scientists are making educated guesses, but that’s all they are. Until a pandemic strain actually emerges and spreads, we won’t know.
And that is not even including how much cross-immunity there might be between the vaccine strain and the circulating strain.
Then you have to add possible adverse reactions, which again in the case of new formulations we will have very limited safety data. I personally am particularly concerned about the use of oil-emulsion based adjuvants like MF59.
Bottom line, it is a matter of weighing all risks against all benefits. Not an easy task.
So the answer to your question is, Yes and No. Depending on what your definition of ‘effective’ is.
anon-22 Are you aware of WHO’s proposal for the use vaccine made at animal vaccine facilites to vaccinate people? If so what is your opinion about this?
Darn-it. Should have included, IN case of emergency.
anon-22 Are you aware of WHO’s proposal for the use vaccine made at animal vaccine facilites to vaccinate people in case there is an emergency need? If so what is your opinion about this? Thank you. Sonny
Yes, these have been discussed especially in the case of China, which has huge antigen generating capacity for avian vaccines. However, the degree of purification required for human use is far more than for poultry use, as you can imagine. The difficulties involved in vastly increasing capacity for purification are, according to Klaus Stohr of the WHO, not something that can be overcome easily, making this idea probably not very viable. However, it IS something to keep in mind.
anon_22: Sorry for topic drift. Has any H5N1 vaccine been proven effective in mice or other lab animals that can be tested? And, in your opinion, is the virus changing so fast that any selection of proteins or strains would prove ineffective in a 3 month vaccine (from protein selection to vaccination)?
Sarah,
I think your contributions are very relevent and I, for one, thank you for making them. This is supposed to be a “free forum” and not just a lecture series.
anonymous – at 10:57
In case you didn’t know, the discussions started by Sarah is now continuing at the General Vaccinations discussions thread.
This is re-posted from the General Vaccination Discussion Thread:
Leo7 – at 03:14 Anon 22:
Gary Matsumoto has written that the GSK bird flu vaccine contains monophosphory lipid A which is the same ingredient combined with squalene he originally wrote about for TRI Max in Gulf war vets. The GSK doesn’t have the squalene but as you know the lipid mentioned above has a list of problems on it’s own.
GM says the danger remains as a cross reaction that initinates autoimmunity. I was surprised because when I first tried to research the proprietary ingredient all I could reference was it was from tree bark. So there, lets X that one off our master list.
Some here might protest, but hey there’s a man offering over 20,000 for anyone, orignally he just asked doctors, to drink the ingredients added to vaccines and so far no takers. If you won’t go drink the concoction don’t complain about the GSK vaccine going off our master list. Let me know if anyone here would like to drink the concoction and I’ll share the website with you.
Sadly, the vaccine A controversy continues….
Did you write to Matsumoto? Yes, I knew that the GSK has that kind of formulation, but didn’t have time to look it up again, thanks. I am not too concerned about GSK because it will take so long for their adjuvant to get licensed that but MF59 is currently still the frontrunner for pandemic vaccine formulation, and that scares me.
Anon 22: Someone else wrote to him and he answered on his message board. It seems that this will be a never ending conflict doesn’t it? I think we should stay focused and monitor the adjuvants being used. At least if we take the shots we know what we’re getting into.
Leo7,
The problem is bigger than that. The government will have to decide which vaccine to go for in the not too distant future. At the moment, the only vaccines that appears to have a fair degree of immunogenicity are the MF59-adjuvanted subunit inactivated (egg-based) vaccine, and the new protein vaccine FluBlok. The problem is the egg-based vaccine companies like Novartis and Sanoffi have powerful lobbies, and I don’t know how a new kid on the block can compete with them. Legislators need to be told that there are credible alternatives, otherwise they will just let the FDA fast-track MF59 as the ‘best’ answer to a pandemic vaccine.
sorry that was me.
annon 22. We have to forget vaccines and move on…they didn’t work, they don’t work and they are not going to work in the future.
The writing is on the wall for this pandemic…we are wasting valuable resources with no return on investment. We have to wait for the technology to catch up with the problem…
…and the biggest problem with infuenza is that it is to genetically unstable…it is a chamelion…changes faster than you can produce a vaccine against it…in my opinion of course. /:0)
Tom DVM – at 18:34 “annon 22. We have to forget vaccines and move on…they didn’t work, they don’t work and they are not going to work in the future.”
Well, that is not my opinion. It is not impossible to find an H5N1 vaccine that ‘works’ ie prevent infection in a significant (how many?) proportion of peope. It is quite a bit harder to get one with the least adverse reaction and relatively good efficacy, AND available in the timeframe, AND be able to persuade the right people to back it.
Things don’t come easily on this planet. Almost all successful scientific pursuits are built on past failures or partial successes.
Personally, I think it is important to keep an open mind about what might happen BUT at the same time guard against the most adverse of consequences. That is where the difficulty lies, trying to determine what might be the least bad of all bad options.
Cos that’s all that we will have, come a pandemic. Barring a miracle, there will be no good options for mitigating a pandemic in the near future.
annon 22. Even if I agree that they will work and I don’t because there were three recent studies that all indicated they don’t work…I would produce them but of course I didn’t save them after I read them. Two were widely reported in MSM in winter 2005 and one from Ontario Canada was from last spring.
However, even if I agreed that they provided some protection, they aren’t going to produce more than 200 million doses at peak capactiy so there is little overall benefit for the cost.
I want supportive therapies instead…give me antibiotics, oral electrolytes etc…they should stop wasting our monies on their pet projects…the magic pills…antivirals and vaccine.
We are going to lose the first 5% no matter what we do…I want to save the next 10% whose deaths will be completely preventable and will be on their heads if they don’t start to stockpile the really important stuff…in my opinion.
Well, Tom, you and I have had this discussion several times. It is not mutually exclusive. Antibiotics and all that are important too. But we cannot base spending decisions on personal preferences. If the vast majority of people in your country are still pro-vaccine (as evidenced by the annual scramble for limited flu vaccine supplies), then you will have to accept that is how they will spend some of that money, and try to find other funding for antibiotics.
It is called living in a democracy. :-)
Absolutely my friend…and that is the best thing about science and the philosophy of science…it is a democracy too…
…and that’s where our friends in China fall down…so to speak…they think we can have totalitarian science.
By the way, do you want to switch sides and argue the other side of the debate next time? /:0)
What side, Tom?
I have posted negative comments on vaccines, when they are negative. I don’t have a side.
Read my ‘attacks’ on some named scientists including the mighty Carl Ayling on the MF59 thread.
“If the vast majority of people in your country are still pro-vaccine (as evidenced by the annual scramble for limited flu vaccine supplies),” Could that be because the public doesn’t have accurate data? Is that called living in a Democracy? Anon_22, why does the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and its members want BARDA? How will this serve a democracy?
Sarah, your arguments are circular and your points have been made numerous times. If you have ‘accurate data’ for the public, or if you believe in the data that you get, fine. I don’t however think there is a need to address again the question about PhRMA, as a) I can’t speak for them, I don’t know them, and b) I’ve already hazarded a guess that they have commercial interests. Whether this serves democracy or not is something that you will have to work out within your political structure (me being non-American), and beyond the scope of this forum.
This forum is for the purpose of discussing issues related to influenza pandemic. This thread was started to discuss general considerations about vaccines. These considerations include political problems and commercial imperatives. Beyond that acknowledging and understanding that, I don’t see how we can seek here to solve the world’s problems.
annon 22. 20:08
That was my point.
So now I’m confused. Which side again?
LOL
Sarah Thanks for your comments.
I am a veterinarian. When I go into a herd of cattle, vaccinations are not open to free choice and it is not a democracy.
There are not going to be vaccination police who are going to throw us on the ground to vaccinate us.
I have made my choice as I assume you have. My family is not going to be vaccinated in a pandemic or purchase or recieve antivirals because I have little faith in either of these ‘magic pills’ that researchers and regulators love so much because its fun!!
I almost died from a delayed vaccine reaction that went on for ten days before diagnosis so please accept my next comments on that basis.
My daughter was born after my experience (had a couple of others with other vaccines as well). She recieved all of her childhood vaccines…I white knuckled it but went ahead anyway…because I believe fervently in vaccines.
I understand your concerns about the carriers etc. and annon 22 has the exact same concerns for good reason…but the benefits of vaccination far outweigh the risks…when the vaccine actually works.
Unfortunately, influenza vaccine doesn’t work so the benefit in this case does not exceed the risk.
Just one more small piece of advice. I respectfully disagree with some of what you have said…and I respectfully disagree with some of what Racter said…and I respectfully disagree with some of what annon 22 has said etc.
It is okay to disagree but it must be respectfull even when others may not be…because the stakes are to high and we both love science.
Thanks again for you input and keep up the good work.
annon 22. BINGO!!!!!
/:0)
Anon_22, “your arguments are circular” Right, I was attacked for suggesting reader’s research vaccines on their own. I was attacked for suggesting the use of Google, by a clown who was pulling reports of the net to support his own argument. I responded to each post that was directed at me. Just like I’m doing now. Is this a violation of the wiki rules? I didn’t think so. IMHO, BARDA is being pushed by some of the same people trying to create a pandemic vaccine. You have shared some current vaccine data and technology. Are some of the institutions you are following involved in the support of BARDA? Do you think the public deserves to know this? American, European, etc.
TomDVM, I simply want all the information available. I believe the public deserves it. We do pay for it! I’m not an “antivax”. I’m also not an android. I make health decisions based on several factors. I’m amused by the Racter’s of the world. They simply can’t bear “civilians” taking control of their own health. He enjoys sauntering into threads and attacking the participants. A good public spanking will do him good.
Sarah, right or wrong, you are just being rude.
“Are some of the institutions you are following involved in the support of BARDA? Do you think the public deserves to know this? American, European, etc.” I just want an answer. Like Racter stated, we are trying to save lives here.
Sarah.
A good public spanking would probably do me good too…but I would rather you didn’t.
You and Racter passionately believe in you individual approaches to vaccination…and that is a good thing…we’ve had enough of half-hearted opinions and efforts by my friends at the…..
I like you…I like that you are righteous…just don’t be righteously indignant…
…it takes away from content of what you want to get across.
Sarah: I may or may not be the “clown” who objected to your instruction to “Google it” as I “pulled reports off the net” to “support my own position” which changes as I read more reports. There are thousands of net citations of varying degrees of reliability. I tried to pick one that was cautious about vaccines and one that was “establishment” (CDC/National Academy of Sciences). I asked you to lead us to citations you regarded as reliable studies. Your consistent response is to “Google It!” and I find that unhelpful. If you wish to persuade rather than bully, it would be helpful to lead us to those who demonstrate in a reasonable way what you assert. There are a lot of goofballs on Google from both sides and rather than spend weeks working through them all, a little judgment would help us.
“Your consistent response is to “Google It!” and I find that unhelpful” then use Yahoo. TomDVM, you’re cool. As you know, the only way individuals can appreciate this complex topic, is to tackle the material themselves. There are many entities with agendas that make this difficult. It’s my hope I inspired some to start the journey. I’m sure I pissed off a couple gate keepers. Go forth public, gather and solve.
Please move these general vaccine discussions to the other thread and save this one for pandemic vaccine. Thanks!
“appreciate this complex topic, is to tackle the material themselves” this was directed toward “pandemic vaccine”. Anon_22, can you share what companies are involved in pandemic vaccine development? Your sources? I can contact a friend and find out if the companies have/are supporting BARDA. This may help when considering the data.
Sarah,
The ones that have been discussed are on my post at 15:34 above with links. These are the ones that I know of. I know that there are plenty of others but as far as I can tell they are further behind in their development. You can probably find them by checking every now and then at the EMEA site by searching for ‘core dossier application’ like this one for the non-adjuvanted GSK vaccine , or at the FDA site.
For the FDA’s approach/thinking on pandemic vaccine, this is a must-read: presentation on Accelerating the development & availability of vaccines for a pandemic or other emerging threats: present and future.
Notice that MF59-adjuvanted H5N1 vaccine is the only one quoted as an example of efficacy. That’s why I suspect it’s the frontrunner, and that’s why it is worrying.
Sorry, if you think BARDA is worrying (which I agree), MF59 is even more so. AND BARDA is the horse that’s left the barn, MF59 is not.
Just my $0.02. :-)
Sarah, Not trying to be cynical, but I suspect every single vaccine company would support BARDA. I mean, why would they not? Unless they think it’s not enough! But then I AM cynical. :-)
“why would they not?” Because it’s dangerous. “They” I’m hoping there are a few “good ones” left in the bunch that still want to help humanity. Thanks, anon_22. This is going to be a rough ride.
Sarah – at 08:24 “why would they not?” Because it’s dangerous. “They” I’m hoping there are a few “good ones” left in the bunch that still want to help humanity. Thanks, anon_22. This is going to be a rough ride.
Unfortunately, CEO’s of commercial entities have to look after the bottomline. Or they will find themselves without a job very quickly. The shareholders will see to that, and that includes all the pension funds etc. :-(
The only way this kind of thing can be overcome is strong regulatory oversight, and governments taking back control of public health. Unfortunately, the lobbyists in DC appear to run the country more than those you elected, who allow that to happen by abstaining from paying attention to what is being passed.
Going at the edge of being off-topic, but in the interest of filling in gaps in people’s understanding.
sorry that was me.
“strong regulatory oversight”
Bump, unfortunately that horse died in about 1983–84.
It left instructions for its tombstone…the inscription reads…
Epidemiologists say: Thin out sick chickens.
Virus says: Thin out stupid people.
Bump, I understand. Sad, indeed.
“Much of the support for the bill comes from Pharmaceutical Researchers and Manufacturers of America (PhRMA) and its members. In the 2002 election cycle, PhRMA contributed $3,505,052 to politicians, with 95% going to Republicans. The top recipient in the Senate was the bill’s sponsor, Senator Richard Burr, who received $288,684, according to the non-partisan Center for Responsive Politics.
Senator Burr said the legislation “creates a true partnership” between the federal government, the pharmaceutical industry and academia to “walk the drug companies through the Valley of Death” in bringing a new vaccine or drug to market.
Exemptions from open records and meetings laws would streamline the development process, safeguard national security and protect the proprietary interests of drug companies, say Republican backers of the bill.[1]”
[edit] Opposition
This post is moved from a different thread to consolidate discussions.
Vaccine Based on Weakened Live H5N1 successful
little5atl – at 15:28
From:
http://www.nih.gov/news/pr/sep2006/niaid-11.htm
When tested in mice and ferrets, experimental vaccines based on live, weakened versions of different strains of the H5N1 avian influenza virus were well-tolerated and protected the animals from a deadly infection with naturally occurring H5N1 flu viruses. The findings, which appear in the September 12 issue of PLoS Medicine, are also encouraging, the researchers say, because they demonstrate the ability to create a vaccine based on one particular strain of the H5N1 flu virus that could potentially protect against different emerging H5N1 flu strains.>><<
Read more at the link above..
anon 22. They are starting to play with fire…and they are starting to scare me…I have seen many train wrecks with this type of vaccine that worked perfectly in the lab and didn’t (under statement) in the field.
I am starting to get the impression that the ‘snake oil’ salesmen are starting to line up at the door…winking and saying under their breath…We are going to make a lot of money out of this.
This is a live attenuated vaccine. The only licensed live attenuated seasonal vaccine currently is Flumist. I know the Russians are working on some.
This particularly one has only finished animal trials, so it will be a while before they are ready.
anon 22 That is a good thing. Surprisingly given the lack of vaccine production in the past, it seems vaccine experts are popping up in almost every country affected by H5N1…and each one of them is now producing their own vaccines…I hope they test them fully before using them.
I believe that H5N1 vaccines in poultry and pigs are exacerbating the problem…and the use of untested vaccines have pretty well resulted in sealing any escape hatches we had left to beat this virus…
We humans are the masters of the world…we have conquered nature…just look at our vast technology…as we vaccinate our poultry and pigs…meanwhile Mother Nature looks on and smiles.
Tom, you are in an optimistic mood today. :-)
/:0) I don’t even like the mention of live H5N1 vaccine.
…and I did say Mother Nature was smiling!!
anon_22 – at 15:49 This particularly one has only finished animal trials, so it will be a while before they are ready.
From the NIH article: “In June 2006, NIAID and MedImmune launched a Phase 1 study to evaluate the safety and immunogenicity of a live, attenuated H5N1 vaccine based on the 2004 H5N1 virus strain. The study, which is being performed in an isolation unit at Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, is evaluating the safety and immunogenicity of the vaccine in approximately 20 healthy individuals between the ages of 18 and 49. Results from that study are not yet available.”
Question for Tom DVM: Is there a type of vaccine that you would regard as mostly safe? Put aside, for a moment, the question of effectiveness. Of course, nothing is absolutely safe and if there is low effectiveness, then essentially no risk is worth taking. I also understand that some people are more likely to have vaccine reactions than others, so their calculation may be different from other people’s. That is why I am asking you if any vaccine “style” is lower risk.
Hi Infomass. I think you should ask both anon 22 and Monotreme and JV and Grace RN and the other medical people on flu wiki…in fact that is not a bad question for another thread at some point…because it is important.
I am all for the statement…If it doesn’t hurt then no harm done…Like many other problems this one is multi-faceted and hard to describe…but pharmaceutical ethics has been rather murky and has been getting murkier over the past five years…I’m sure you have heard the same stories I have…
…The vaccines produced during a pandemic are going to be produced in panic mode by a reduced workforce…almost every country in the world has had a vaccine delay this year without a pandemic threatening all of their families…
…Therefore, in light of the preceeding marginal overview, I would say that killed vaccines are safe…live vaccines are not…especially when putting a live H5N1 vaccine that can replicate into humans…not good…obviously not good.
Killed vaccines as long as they killed them properly should be relatively harmless…vaccine reactions will always be there…
…but remember at full production and taking over production that would have gone to seasonal vaccines…I think the full capacity is 200 million vaccinations for a population of 6.5 billion…
…and these vaccines won’t be avaliable until most of the damage from the pandemic is done…and yet all their resources are going to vaccines (won’t work) and antivirals (don’t work).
Tom DVM: Thank you. I guess I hope that they figure out a way to create a killed vaccine that would be easier to produce in large amounts faster than the old current egg based method we still use. But it is a lot to figure out in a very short period of time. I share your concerns about both the drug companies and the government.
INFOMASS – at 19:06 “Tom DVM: Thank you. I guess I hope that they figure out a way to create a killed vaccine that would be easier to produce in large amounts faster than the old current egg based method we still use.”
I believe the HA protein vaccine is it.
anon 22. Thanks I hope you are right and even better…I hope they have time to do…all required studies to prove beyond a shadow of a doubt that it works and it doesn’t have excessive rates of vaccine reaction.
As I am sure you would agree…the last thing we would need is an untested, unproven vaccine produced under the extremes of a pandemic.
Here’s the link to the discussion on recombinant haemagglutinin vaccine
Currently, for those vaccines that are almost close to ready for market, I would personally rank this for safety as well as having half a chance of getting enough to cover a large percentage of people in time, if TPTB get their act together and focus on science and not the politics of DC lobbyists.
The second one would probably be the Sinovac inactivated whole virus with alum as adjuvant, although I don’t know how likely it is that it will be available for folks outside of China, unless they complete their research pretty quickly and is willing to sub-license the process to other countries. I’m rather skeptical at the moment.
I wouldn’t trust anything with oil-emulsion based adjuvants, although if it was a choice between that and death, well, maybe…..
Just my 2C, at the moment.
Time to revive this thread. The information about MF-59 adjuvant and oil-emulsion adjuvants made me so very uncomfortable. So when I came across information about using virosomes in a vaccine, both as adjuvant and vehicle for delivering influenza antigens, my ears perked up a bit. The technology is already approved
There is an influenza vaccine using the virosome system commercially available and approved in 40-some countries (not sure about the U.S.), it is called Inflexal V. The manufacturer claims it has no preservatives, and has a good safety profile, excellent tolerability, and high immunogenicity. Information about it is here and here. There are numerous studies available about Inflexal and virosomal-based vaccines, which can be accessed at PubMed using search words “Inflexal” or “virosome”.
One 2005 study briefly gives this info.
Vaccine. 2005 Jul 8;23 Suppl 1:S39–49. Clinical experience with inactivated, virosomal influenza vaccine.
“…All three studies explored the long-term persistence of antibodies after vaccination with virosomal influenza vaccines. Immunogenicity declined over time but remained high at 4, 6 and 12 months post-vaccination compared to baseline, indicating that adequate seroprotection is achievable for the duration of the influenza season.” (PMID: 16005120)
If anyone has further information about efficacy of this vaccine method, or availability in various countries, please jump in. Not being a person to run out and get a vaccine at every turn, if the influenza threat became very serious - given this information I would choose the virosome-based vaccine over others that contain potentially harmful adjuvants and/or preservatives. And besides, protection appears to last longer.
Arrrgh, sorry for disjointed post above, had an interruption!