DURHAM - Here's an ironic update for anyone who was concerned about his family's safety a few months ago, when everyone was talking about a deadly bird flu pandemic and government officials said there was no vaccine available.
Just recently, a pharmaceutical company announced it had developed a new, and possibly much better, vaccine to prevent bird flu. The company, GlaxoSmithKline, says it's ready to produce enough vaccine for 80 million Americans, which would go a long way toward heading off a crisis.
I have spoken to people from GlaxoSmithKline. Human trials of the "vaccine" have already begun (this is more in reference to the patients in Belgium). There is no mention of funding needed to conduct these trials.
GlaxoSmithKline initiates human trial programme with two H5N1 pandemic flu vaccines
GlaxoSmithKline (GSK) announced today the start of an international clinical trial programme to test two pandemic vaccines against the H5N1 strain of the avian influenza virus in humans. This dual approach reflects the company’s commitment to provide health authorities with concrete options to face the threat of a pandemic.
A clinical trial just initiated in 400 healthy adult volunteers in Germany is testing a pandemic flu vaccine using a classic alum adjuvant to improve individual’s immune response and possibly allow a lower amount of antigen to be used per dose. This trial supports a dossier GSK submitted to European regulators in December 2005. Should a pandemic flu strain be identified by the World Health Organization, a variation to the dossier would allow rapid European registration and production of a pandemic vaccine.
In parallel, a clinical trial conducted in Belgium in 400 healthy adults is testing a candidate pandemic flu vaccine that contains a novel adjuvant system. GSK is hopeful that a vaccine formulated with this novel adjuvant will further enable individual’s immune system to respond to different H5N1 virus strains, offering a broader protection against the threat of a pandemic. GSK’s novel adjuvant technology is also expected to further reduce the amount of antigen needed per dose, increasing the number of doses the company could make available worldwide. Such a vaccine would offer governments additional options of stockpiling and vaccinating ahead of a pandemic outbreak.
Both trials are testing the vaccine’s safety and ability to boost individuals’ immune response against H5N1. Tested vaccines are made from inactivated (killed) H5N1 virus. Different dose levels are being studied. Volunteers are to receive two vaccinations approximately three weeks apart. The studies will allow GSK to select an optimal dose and formulation for subsequent safety trials in groups at high risk of complications following influenza infection, such as children and the elderly.
Preliminary results from the clinical trials are expected in the third quarter of 2006. GSK plans to have a pandemic flu vaccine in production before the end of the year.
Jean Stéphenne, President of GSK Biologicals, the vaccine division of GSK said: “We are moving forward with clinical trials of vaccines which could prove a vital part of the world’s response to a flu pandemic. While the first vaccine candidate aims at mounting a strong defence against a pandemic outbreak, the second vaccine may offer governments a preferred option to proactively stockpile and begin vaccination before the onset of a pandemic, significantly increasing the speed of a public health response in the event of an outbreak.”
Emmanuel Hanon, GSK head of Flu operations worldwide explained:“We believe that vaccinating populations with the appropriate H5N1 vaccine will help educate the body’s immune system and reduce expected morbidity and mortality associated with a pandemic. This means that if the current bird flu virus mutates to allow human-to-human transmission, a vaccinated person will be better prepared to combat the H5N1 pandemic flu virus.”
H5N1 avian influenza infections lead to severe disease in both birds and humans. Public health experts fear that the virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic. Influenza pandemics are global outbreaks that involve viruses to which humans have little or no immunity. H5N1 is one such flu virus strain.
GlaxoSmithKline, a leader in Flu treatment and preparedness
GlaxoSmithKline has an active research and development program targeted at both seasonal and pandemic influenza and has recently committed over a billion pounds ($2 billion) to expand capacity for manufacturing flu vaccine and its anti-viral influenza treatment Relenza® (zanamivir for inhalation).
GSK was the first company to submit a “mock-up” dossier for a pandemic vaccine with traditional alum adjuvant to European regulators in December 2005. Under new European rules, the vaccine was given accelerated review status. Should a pandemic flu strain be identified by the World Health Organization, a variation to the dossier would allow rapid registration and production of a pandemic vaccine more closely matched to the circulating pandemic strain.
In North America, GSK recently acquired a major influenza vaccine manufacturer, ID Biomedical Corporation. This acquisition provides GSK with a significant increase in flu vaccine manufacturing capacity. The production capacity of the newly acquired Canadian facilities - combined with GSK’s expanded vaccines manufacturing plant in Dresden, Germany - is expected to reach around 150 million doses per year by 2008. These numbers are based on production of trivalent seasonal influenza vaccine. The production capacity of a monovalent flu pandemic influenza vaccine can be expected to be significantly higher.
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit: www.gsk.com.
However if one wanted to invest directly in GlaxoSmithKline :
European Analyst/ Investor enquiries: |
Duncan Learmouth |
(020) 8047 5540 |
|
Anita Kidgell |
(020) 8047 5542 |
|
Jen Hill |
(020) 8047 5543 |
|
David Mawdsley |
(020) 8047 5564 |
GSK is also the producer of Relenza. It is an alternative anti-viral - which is much more difficult for the current human pathogenic Avian strains to develop a resistance to. Developing a vaccine for the current form of human Avian would be in most cases inneffective to new mutated highly virulent pathogen which does not exist yet. A new vaccine (except as cited in a type of reserach which focuses on parts of the the virus common to many strains) would probably need to be developed.
One researcher at one source quoted me a very off-the-cuff amount of $500 per dose cost, it fairly large amounts were manufactured. Whether this is directly to purchaser of large quantities or to each patient (unlikely) considering the value, this is not over the top.
There is sizable grant money available from national Federal health coffers for vaccine and research.
Public health officials want more test results before approving the vaccine for widespread use, which is reasonable. But they haven't offered the company a contingent contract to begin producing vaccine quickly if the results are favorable.
All of us researchers and research institutions compete and desire federal grants.
Why not? Because our country' system for producing vaccines doesn't allow that -- just one of many ways in which the system remains broken.
Some real research needs to be done here. For one, Congressional Representatives and Senators can introduce funding bills and it is a common practice to make money available, sometimes immediately (given a national security or national health emergency). Is our system broken? Do we need to start sendng money directly to "whom?" to speed up the process? Or would it be more effective to directly contact congressional people from your district, make them aware of your concerns, and have them push for funding?
Little has changed since the Institute of Medicine, in a 2003 report, called for a new financing system to encourage companies to develop and distribute vaccines. That report was followed by widely publicized vaccine shortages, and then by the bird flu problem, which highlighted the urgent need for action. Yet the problem persists.
This is a highly sweeping statement. For one, there has been a massive mobilization at all levels of government to deal with a possible Avian pandemic. CDC, WHO, and Homeland consisting of countless workers are on this 24/7. Most of the time you will never know when or what they have done to protect the country, but their efforts have stopped, as was publicized recently attacks and saved millions of lives. Not only are 30 institutions we know of working and some testing vaccines, but around the world top researchers have taken on this problem head on and tackling the problem.
In someways, since SARS, Katrina, and now the outbreak of human Avian, massive plans as well as programs have been put in place to deal with these issues. As much has changed in some sectors, not all visible to the public, as has changed in fighting "hostile anti-American groups" before 9/11.
As a physician and health economist, and also as a parent, I would welcome the opportunity to start protecting my family on my own.
I think the term "human being" would sufficient trying to save lives. True I could say with an expectant wife, and a huge family group, etc. But the inference here is that our own people and research teams are not up to the task with the backing they have to create a vaccine. It has already been done. There several. Financing for testing? Human trials are being done in several companies. Billions of dollars are already being invested. This is so interesting worded so that you can "prepay" to be sure that you will be sure to get your dose, because if you do not, you may not get it.
For instance, I would be happy to buy a bird flu treatment kit for my family that would include doses of medication that we would only use in a pandemic. If the medications expired and I had to buy another kit next year, I would still be glad that I had acted to protect my family. State Medicaid programs could make the same option available to those who cannot afford to pay for this "insurance."
Sounds like some pretty fancy marketing to buy something which is untested and may not even be developed.
How about prepayment? I could buy my influenza vaccine dose in advance, and manufacturers could be assured of a significant market before production. I would receive discounted pricing from my vaccine provider of choice.
This is like saying there will be a huge chunk of money in a bank account for X person to develop the vaccine which assures us that someone will develop it. Am I missing something here? You have 30 companies working at top speed to develp this at least.
It may have been the opinion, and has been heavily publicized that the development of a vaccine for Avian would not be as profitable and therefore has resulted in many companies balking at this, in the past - but looking towards the purchase of 400,000,000 doses of Tamiflu is hardly a low market item. Also, in the case of current outbreaks which are present in foreign countries you are looking at already existing market of the nations which already have the disease.
Prepayment, subsidizing research, marketing division of a known university? Some of the most difficult problems in our country will be the production and distribution of the vaccine once it is developed. The current mode would be vaccine or anti-viral innoculation sites whose locations will be kept secret until the substance has been transported, is under armed guard, and will be given by health professionals.
In recent trials of Tamiflu given in improper dose and course, resistant organisms developed in the first group. Given the fact that a Pandemic may be crippling to our postage service, delivery services of all kinds, shipments of the drugs may be stolen and there will be no mailback rebate coupon or product support line - no need to belabor the point.
It has been an interesting thread. It would be a comforting thought to have a nice little vaccine kit sitting there, but unless we can develop a vaccine which can anticipate and is effective against what is coming, billions of dollars worth of money, salaries, and grants may go into something which simply doesn't work.
There is a market for wine futures and "dread disease" insurance. Why not a futures market on vaccines? I could buy my dose in advance and share in the risk of development. Manufacturers would be assured of a significant market before taking on the costs of production. They would also receive some advance financing. That's a lot more than a company like GlaxoSmithKline gets under the current system.
Open for shots on this one, but it would be more likely for insurance companies to exclude a massive pandemic as an "Act of God" type clause with either capped medical coverage (what exactly are they going to do if they have no safe vaccine?) They certainly aren't going to get higher premiums and more money to pay for this. So I guess we are hearing, for your "donation" you will be first in line to get a "brand new vaccine kit." When the "big one" (earthquake) hit in California and I was actually with a patient at the time on the 7th floor of Kaiser Hospital in the "Unit" a lot of "earthquake insurance" packages blossomed forth.
Unfortunately, the deductables, and the wording of the contracts was such that the value of the home (deprecieated and then decreased even more) provided no realistic protection.
One does not want to be too harsh, but it is akin to a disease announcement being made and the Instant Tellers being either shut down or miniscule withdrawals allowed. All of this works in business as usual environment, but it is unlikely if there are complications - and that is what the military and government are looking at - people are not likely to behave themselves.
We could apply the same approach for threats besides bird flu, notably including bioterrorism possibilities such as smallpox or anthrax that are remote but present a high risk. Again, I'd be willing to spend my own money to protect my family from these biological agents, purchasing the supplies myself and thereby easing the burden on the public purse. If others joined me, we would thereby expand the market, making it more attractive for manufacturers to produce supplies. Government would assume responsibility for those unable to buy supplies privately.
Where is this "own money" going to go? Is there an online downloadable business plan for this venture?
These approaches are not the only market-based alternatives to our current broken system. Once we start looking at the problem with new eyes, it's possible to identify a variety of approaches to encourage more companies to get involved while enhancing the public health.
The bottom line is this: The current system is broken. I'm willing to pay for vaccines. You might be, too. So long as the government steps up to its responsibility to protect those unable to pay, we should stop spinning our wheels and try to find ways for each of us to take steps toward preventing the next public health crisis.
I probably need some clarification here. In a national pandemic with an emergency vaccine, I doubt we are going to be processing Medicaid numbers.
Conclusion of Comment : I am sure that this is mostly, it sounds like a great idea. I sounded like a great idea when the Red Cross was shipping food to Africa and the rebels were unloading from the boats and using to feed their armies. We don't even have a Pandemic and already insurance companies, marketing firms, Wall Street, and banks are hustling with contingency plans. Call me unrealistic. If we can, I am sure the government, state, local - whoever will be trying to supply water, food, and hopefully vaccine as best we can. Anyone who tells you that you can buy a pre-paid reservation for a save your familiy virus kit.
OPINION:
no thanks.