If there is a Pandemic with anything like the current 50% plus case fatality rate (God Forbid), the private companies making vaccines will have a weak hand and they know it. While "ownership" of the company may be outside the country the vaccine production facilities are in, as they say, "possession is 9/10 of the law".

When true life and death is involved, a country will do anything to secure a potential life-saving vaccine. This could be "nationalizing" the facilities (a complete takeover of the business), a temporary "protective custody" of the facilities (enforced by the military), or as Helen Branswell indicated in the above article:

No one involved wants to play such naked power games, so therefore the "negotiations" going on in Canada (and no doubt, elsewhere). The companies have a very weak hand in such negotiations. About all they can get out of this is money, while resisting pressure from their countries of origin to "bring the vaccine home", and bribes from other countries to place them first on the list.

There is also going to be pressure on the Companies (and agreements) from/with the U.S., which is financing most of the Pandemic vaccine R & D., and has a population of 300 million or so to protect (and currently only one vaccine producing plant).

Additionally, the WHO and Third World Countries are already starting to pressure the Companies to make Pandemic vaccine available for poor countries.

The stakes in this game are huge; life and death, gobs of money, International Politics, and business survival. Everything will be on the line if a Pandemic hits in the next few years. With too many people and too little vaccine, agreements will be broken, and wars may be fought for access to some vaccine plants.

Italy's population should get first access to any Pandemic vaccine made within their borders (or else), however, there might be growing pressure and danger from Italy's neighbors for the precious Pandemic vaccine.

Those two vaccine plants could be a blessing, and a curse, during a crisis that could last a year or more.


 

http://english.people.com.cn/200608...828_297478.html

 

Seems interesting, shares jumped 13% at opening on Nasdaq ( symbol SVA); Sinovac seems to be ahead now.

Preliminary Result of Phase I Clinical Trial Shows That Sinovac's Pandemic Influenza Vaccine (H5N1) has High Safety and Immunogenicity Profile
Monday August 28, 8:30 am ET

BEIJING, Aug. 28 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. (AMEX: SVA - News), announced that the preliminary result of the Phase I clinical trial on Pandemic Influenza Vaccine (H5N1), which is supported by the Ministry of Science and Technology of the People's Republic of China, co-developed by Chinese Centers For Disease Control and Prevention (CDC) and Sinovac Biotech Co., Ltd., was discovered recently. The result proves that the vaccine with different dosages can induce an immune response, of which the vaccine contained 10ug antigen has been proved to have the best immunogenicity with the sero positive rate of 78.3%, which exceeds the EU CHMP criteria for seasonal influenza vaccines (greater or equals to 70%). There is no serious adverse event reported on.


Additionally, the Company will reconstruct the seasonal influenza vaccine plant to expand the production capability for pandemic influenza vaccine (H5N1) to 20 million doses per year and thereby it allows the company to have enough stockpiling capability of vaccines for the influenza pandemic.
The project is attracting a lot of Government attention. The National Development and Reform Commission has decided to provide financial support to the project.
The reconstruction project for Sinovac's seasonal influenza vaccine plant is expected to be completed in 2007. The reconstructed plant can also be used for the production of seasonal influenza vaccines. It is reported that the seasonal influenza vaccines manufactured in the plant will be launched into the market this autumn.
On November 22, 2005, the State Food and Drug Administration (SFDA) approved Sinovac to commence a phase I clinical trial on its proprietary Pandemic Influenza Vaccine (H5N1)... On December 21, 6 volunteers in the first group were vaccinated with the testing vaccines. The Clinical Trial was conducted with compliance with the requirements of receiving volunteers' consent and approval from ethic committee and the design of randomization and double blindness. In June of 2006, the code-breaking procedure of the Phase I clinical trial was completed under the witness of the Ministry of Public Health of People's Republic of China and the supervision of the State Food and Drug Administration (SFDA), the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), Centers For Drug's Examination and Evaluation, and the Data Safety and Monitor Board.
The result showed that all of the four different dosages of antigen used in the clinical trial can induce an immune response. Among the four dosages, the vaccine with 10ug antigen has been proved to have the best immunogenicity with the sero positive rate of 78.3%, which exceeds the EU CHMP criteria for seasonal influenza vaccines (greater or equals to 70%). There is no serious adverse event occurred on the 120 volunteers vaccinated with the vaccine. According to the results of Blood routing Test, Clinical Biochemistry Test, Urine Routing Test, and the observation of systemic and local adverse reactions, it is proved that the vaccine is well-tolerated.
The Pandemic Influenza Vaccine for Phase I clinical trial is an inactivated whole virion vaccine. The virus strain used for the development of the vaccine is NIBRG-14, which is recommended and provided by World Health Organization (WHO). The virus strain was a reassortant strain prepared using reverse genetics, which is non-pathogenic. The vaccine is adjuvanted with aluminum hydroxide, which can enhance the vaccine's immunogenicity to human bodies, reduce the antigen content for certain level of immunogenicity, and cover larger population.
It is announced by the management of Sinovac that they are preparing for the application for Phase II clinical trial on Pandemic Influenza Vaccine (H5N1) with Chinese Centers For Disease Control and Prevention (China CDC).
About Panflu(TM)
Sinovac's Panflu(TM) is an inactivated whole virus vaccine with adjuvant. Four antigen dosages levels were tested in the Phase I clinical trial and all of them induced an immune response in the volunteers. The vaccine with 10ug antigen content demonstrated the best immunogenicity, with a sero-positive rate of 78.3%, which exceeds the criteria for assessment of vaccines established by Committee for Proprietary Medicinal Products of the European Union.
International Cooperation
The National Institute for Biological Standards and Control (NIBSC) provided Sinovac with a reassortant H5N1 virus strain to be used in the vaccine R&D process.

http://biz.yahoo.com/prnews/060828/cnm015.html?.v=5

Disclaimer: poster does not have shares SVA . 

Some more info on the same with an extra bit that wasn't in the article you linked. While the key word in the highlighted passage is "might be useless" it's
a pretty big might.

http://www.thanhniennews.com/health...=8&newsid=19390
Initial tests show China's bird flu vaccine safe for humans


A bird flu vaccine that Chinese researchers are developing for humans was safe and effective after successful preliminary clinical tests, state media have said.
Trials of the vaccine were launched last December and some 120 Chinese volunteers have since received shots of the experimental immunization against the deadly virus, the Xinhua news agency said Monday.

The participants, previously reported to be healthy people aged between 18 and 60 from Beijing, have shown "no serious adverse reactions," researchers were cited by Xinhua as saying.

Results showed that the vaccine successfully stimulated the production of antibodies in the participants to fight the virus, Xinhua cited the vaccine manufacturer, Beijing-based pharmaceutical firm Sinovac Biotech Co., as saying.

The company jointly developed the inoculation with China's Ministry of Science and Technology and China's Center for Disease Control and Prevention.

Sinovac said the 10 microgram dosage of the vaccine proved most effective, stimulating 78.3 percent protective antibodies, exceeding the European Union standard of 70 percent for a flu vaccine, according to Xinhua.

Another phase of clinical trials will need to be conducted before the vaccine can be approved. It was expected to take at least a year before the vaccine finishes its two-phase clinical trials.

If approved, it will first be used on high-risk groups such as veterinary and laboratory workers and poultry farmers in afflicted regions, a company official had said.

It would also be cheaper than normal flu jabs.

Various companies around the world are trying to develop a vaccine against the virus, but the World Health Organization's top official in China has said vaccines might be useless in the event of a bird flu pandemic as the virus would have mutated.

It was difficult to predict how the virus would mutate and it could take months before a new vaccine was then produced, the official has said.

The H5N1 virus circulates among wild birds and poultry and can be passed to humans, normally those who come into contact with such animals. The disease has killed about 140 people, mostly in Asia, since 2003.

Twenty-one people in China have contracted bird flu, and 14 of them died, with the most recent fatality occurring in July, according to official figures. 

__________________ 
If you stand for nothing, you'll fall for anything. 

Silent spread of H5N1 in vaccinated poultry.

Savill NJ, St Rose SG, Keeling MJ, Woolhouse ME.
Centre for Infectious Diseases, University of Edinburgh, Ashworth Laboratories, The King's Buildings, Edinburgh EH9 3JT, UK. nick.savill@ed.ac.uk

International debate on the merits of vaccinating poultry against the H5N1 influenza A virus has raised concerns about the possibility of an increased risk of between-flock transmission before outbreaks are detected. Here we show that this 'silent spread' can occur because of incomplete protection at the flock level, even if a vaccine is effective in individual birds. The use of unvaccinated sentinels can mitigate, although not completely eliminate, the problem.

PMID: 16915278 [PubMed - in process]

http://www.ncbi.nlm.nih.gov/entrez/...l=pubmed_docsum

I suppose this "silent spread" could happen between vaccinated humans. Still better then nothing... 

 

Drifter, yes, vaccine may be useless, but most people don't think so.
IMO all these news are importante because:
- demonstrate the interests of vaccine companies
- any test and experiment taken now will be very preciuos in the future: it's a step ahead
- vaccine manufacturer are tring to find better and faster ways to produce vaccine, IMO we are 1 year away from the "final" cell vaccine easy and fast to produce

BTW stockpiling current vaccines are probably a wise option for now: obviously the best vaccine will be produced when the virus will be H2H, but most think that it will not be completely different from today one (it will be H5 anyway) so current vaccine can probably save a lot of lives anyway. That's to say: with current vaccine you will be ill, but probably you will not die.

That's what I think about this, and why I "track" all vaccine development 

justathought very interesting article.
It's also interesting to see that current global production capacity is 0.5 billion doses for year, of course insufficient for blocking a pandemic even if immediately available. We need cell based vaccines ASAP 

not too many information about this... sorry

http://www.forbes.com/business/feed...afx2981662.html

 

Sanofi/Pasteur is building a vaccine plant right now in France with facilities for cell based culture (PERC.6 Crucell). Should be ready early next year.

Edit: It is a facility for massproduction: 20.000 liters in one run, that is millions of flu shots. Sanofi will build another 20.000 liter facility in the USA. 

Wednesday August 30th, 2006 / 8h28

Edited Press Release
AMSTERDAM -(Dow Jones)- Scientists at Akzo Nobel's Nobilon International human vaccines business working to fight the threat of a global bird flu pandemic have received a major boost following the signing of a cooperative research and development agreement with the Centers for Disease Control and Prevention (CDC) in the United States.
The agreement-co-signed with Nobilon's international partner, Australian-based BioDiem Ltd-involves the development of a live attenuated cold-adapted cell culture vaccine against the H5N1 strain of the avian influenza virus.
According to experts at the World Health Organization, a live vaccine would offer better and broader protection in the event of a pandemic outbreak.
In 2004, the two companies agreed a licensing deal for BioDiem's cold-adapted intranasal flu vaccine and this technology will now be advanced through pre-clinical development at the CDC in its high-security laboratories in an effort to develop a vaccine which will protect against highly pathogenic avian influenza viruses that pose a pandemic threat.
"This is an extremely important collaborative agreement which could prove crucial in our efforts to develop a vaccine for one of the world's leading health risks," said Toon Wilderbeek, Akzo Nobel's Board member responsible for Pharma.
"A key challenge for developers of potential pandemic vaccines is sufficient supply. One of Nobilon's main areas of cutting-edge expertise is in cell culture production to provide benefits of scale-up, speed and efficiency. This is vital to any effective vaccination program."
The cooperative research-to be carried out over two years at Boxmeer in the Netherlands and Atlanta in the United States-will generate, characterize and evaluate in pre-clinical models, live attenuated cold-adapted influenza vaccine (LAIV) candidates against influenza H5N1 viruses.
A live attenuated influenza vaccine has been shown to have a number of advantages. It can trigger a broader immune response than inactivated influenza vaccines in children, as well as allowing for a single dose of a smaller amount of vaccine to provide meaningful protection, compared with currently available inactivated vaccines.
The U.S. government has also recently acknowledged that cell culture production of influenza vaccines may provide a superior service compared with the traditional supply based on embryonated eggs. This is because the production timeline may be shortened and vaccine production may be increased with fewer delays.
Pharmaceutical development company BioDiem's existing agreement with Nobilon gives the Akzo Nobel business access to BioDiem's technological expertise in influenza vaccines. Nobilon also has exclusive rights to manufacture, market and sell BioDiem's intranasal influenza vaccine in a number of key world markets.

http://www.akzonobel.com/com/News/N...f0-507f6f0cee0a 

Attached Images

 

Very very thanks Dutchie!
From your image I see a cell vaccine is already here (Influvac TC). Isn't it? 

It is a cell vaccine (dog cells, MDCK) for "normal" flu, see

http://www.clinicaltrials.gov/ct/se...u&submit=Search

The FDA compared different cell lines, they have some questions among others about tumorigenicity (cancer). It seems that MDCK cells have stronger tumorigenicity than human cells (PERC.6) see slide show FDA:

http://www.fda.gov/ohrms/dockets/ac.../5-4188S1_1.PPT 

There could be a huge risk in rushing some of these new vaccine technologies into production.

We could dodge the H5N1 bullet, only to find out there were long-term consequences like cancer, infertility, birth defects, etc.

What a choice in an emergency:

Millions of short deaths on the one hand, or millions of long term deaths or serious adverse effects, on the other....


 

Agreed, we should not rush. I think you are painting a to dark a picture:
if MDCK cells have strong tumorgenicity, other cells like PERC.6 dont have this problem. 

True, Dutchie. It is only a dark-side picture if we run out of time for adequate testing and development. It does concern me to see the vaccine development field flooded with money, pressed for results, and the drug companies protected from liability. I know time is of the essence, but I hope the industry can balance profit and political pressure with public safety (or the dark-side picture may be tested).

I do believe that effective vaccines are the ultimate answer to the H5N1 threat. If there is no H5N1 Pandemic, we will be able to face other challenges in the future with better technology and vaccine production facilities.


 

Adequate testing, that is of utmost importance; the protection from liability is a shame indeed! 

New Vaccine Against Bird Flu

Article Date: 31 Aug 2006 - 0:00am (PDT)


A new vaccine against bird flu being developed by an Australian company is a step closer today with the announcement that CDC Atlanta will conduct pre-clinical trials on a candidate vaccine developed by Melbourne biotechnology company BioDiem and Dutch company Akzo Nobel's Nobilon.

The flu virus changes every season. So today's flu vaccines are grown in chicken eggs each year using a killed version of the current influenza virus doing the rounds. It's a slow process - too slow if a pandemic bird flu emerges.

If it passes the trials, BioDiem's vaccine will have several advantages.

It is a live vaccine and their seasonal flu vaccine based on the same technology has been shown to give broader protection against influenza virus variants in comparison with an inactivated flu vaccine. So while an inactivated pandemic flu vaccine would have to be remade to be effective each time the flu virus genetically changes, BioDiem's flu vaccine would be expected to still provide meaningful protection.

The new vaccine can be grown in cell culture, so it can be mass produced faster. The current vaccine is made in eggs - a time consuming process taking at least three to four months - and the world capacity for vaccine production in eggs is limited, particularly if the chickens are infected.

It will require just one dose and will give coverage within a day of administration. The inactive vaccines in development require two shots three weeks apart and then take two weeks to give protection.

The new vaccine would also be administered as a nasal spray, allowing fast distribution and no needles.

The US CDC at Atlanta is amongst the world's foremost authorities in emerging disease threats so it's exciting that they have agreed to run the pre-clinical trials.

http://www.scienceinpublic.com 

Attached Images

 

Questions surround China bird flu vaccine

HONG KONG (Reuters) - China is working on a bird flu vaccine for humans and initial test results suggest it is safe and effective, but a leading expert is treating the news with caution, saying more details and independent checks are needed. Government-backed Beijing Sinovac Biotech Co. said this week it had developed a H5N1 vaccine for humans, using a strain of the virus that had been found in recent years in Vietnam.
In the first clinical trial that ended in June, 120 volunteers were injected with the experimental vaccine and none showed "serious adverse reactions". Their blood and urine showed the vaccine was safe for human use, Sinovac said in a statement.
Four different dosages of the vaccine were used, but the one with 10 micrograms appeared to be most effective, stimulating 78.3 percent of protective antibodies. The company gave no other details on the vaccines.
But an expert greeted the news with caution and asked if independent laboratories had carried out tests for antibodies.
"Lots of tests are needed to evaluate the effectiveness of any experimental vaccine," said microbiologist Guan Yi at the University of Hong Kong, who has studied the virus since it made its first known jump to humans in Hong Kong in 1997.
"Vaccines made elsewhere have to be tested and verified by dozens of independent laboratories at every stage. This is the acceptable standard," he said.
The Chinese vaccine was jointly developed by the Chinese Centers for Disease Control and Prevention and supported by China's Ministry of Science and Technology.
Pharmaceutical companies around the world are trying to develop a vaccine for the H5N1 virus, which experts fear could mutate into a form that can pass easily among humans, possibly killing millions. For the moment, the virus remains essentially a disease in birds.
Flu viruses mutate constantly and experts fear that any pre-pandemic vaccine that is designed now might not confer enough protection against the eventual pandemic strain, if it emerges.
RATIONALE
Questions surround the positive test results from China.

"How many of the participants developed antibodies?" Guan asked.

He questioned the rationale for using the Vietnam strain as a basis for the vaccine because different strains are circulating in Indonesia, northern China, Europe, the Middle East and Africa.
"This strain is different from the one in Indonesia and new ones that have emerged in other places," Guan said, calling for a more systematic and mature criteria on selecting the vaccine strain and the manufacturing process.
"The vaccine could bring a small reaction for other H5N1 strains, it won't be completely ineffective. But when you create a vaccine, you try to make one that confers the most widespread protection, but the coverage of this one is narrow," he said.
Sinovac, meanwhile, has plans to refurbish and expand its existing plant for seasonal flu vaccine to produce up to 20 million doses a year of pandemic flu vaccine from 2007.

http://today.reuters.co.uk/news/art...C1-ArticlePage2 

Even though this is about SARS it also mentions application in regards to AI.
http://www.dailypennsylvanian.com/v...0/44f64cfe171a1
News Brief: Penn researchers develop SARS vaccine
August 30, 2006


A clinical gene vaccine to combat a severe respiratory disease has been developed in a cooperation between Penn and Sun Yat-sen University in Guangzhou, China. The vaccine, the first gene vaccine for severe acute respiratory syndrome, is expected to be launched pending additional testing. It has already been tested on animals and was researched at Penn. SARS, an infectious disease, was found in parts of Asia and across the world in 2003. In addition to the SARS vaccine, the joint project is intended to work on vaccines against AIDS, avian flu and other epidemics. - By Alanna Kaufman 

__________________ 
If you stand for nothing, you'll fall for anything. 

http://www.mytelus.com/news/article...ticleID=2380299

 

Here is the NIH release.

http://www.nih.gov/news/pr/sep2006/niaid-11.htm

Live H5N1 Avian Flu Virus Vaccines Show Protection in Animal Studies 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.

Senior investigator Kanta Subbarao, M.D., M.P.H., and co-chief Brian Murphy, M.D., both of the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), led the research. The study was the result of a cooperative research and development agreement between NIAID and MedImmune Inc., of Gaithersburg, Md.

“This is an excellent example of the NIH and industry working together to find scientific solutions to potential public health problems,” notes NIH Director Elias A. Zerhouni, M.D. “Developing a vaccine that could protect against a potential influenza pandemic is a top priority for all of us.”

“If an influenza pandemic were imminent or under way, we would need a vaccine that could stimulate immunity quickly, preferably with a single dose,” says NIAID Director Anthony S. Fauci., M.D. “The encouraging findings of this study suggest that vaccines based on live but weakened versions of the H5N1 avian influenza virus may quickly stimulate protective immunity. We are further exploring this live, attenuated vaccine strategy as one of several tools that we hope to have available in the event of an influenza pandemic.”

As of September 8, 2006, there have been 244 confirmed human cases of H5N1 infection and more than half of those were fatal, according to the World Health Organization (WHO). Public health officials worry that the H5N1 virus will evolve to become easily transmissible among people, potentially sparking an influenza pandemic, because humans have no pre-existing immunity to the H5N1 viruses.

The NIAID and MedImmune research team created three vaccines by combining modified proteins derived from virulent H5N1 flu viruses with proteins from an artificially weakened (attenuated) flu strain. The virulent H5N1 viruses were isolated from human cases in Hong Kong in 1997 and 2003, and Vietnam in 2004. The attenuated flu vaccine strain, which also serves as the basis for MedImmune’s FluMist® influenza vaccine, was lab-grown in progressively colder temperatures (“cold-adapted”) to prevent the resulting vaccine viruses from spreading beyond the relatively cool upper respiratory tract. Large quantities of the resulting cold-adapted viruses were grown in chicken eggs.

The safety of the vaccine viruses was evaluated in chickens and mice. In chickens, the H5N1 vaccine viruses were not lethal, while each of the three strains of the “wild-type” (naturally occurring) H5N1 viruses were. Similarly, the vaccine viruses were not lethal in mice, but the 1997 and 2004 strains of the wild-type H5N1 viruses were. The 2003 strain of the H5N1 wild-type virus was not tested in mice because the researchers found that the virus was lethal in those animals only at very high doses. Because the wild-type H5N1 viruses have been shown to replicate in animal lungs and brains, the researchers tested the ability of the 1997 and 2004 strains of the vaccine viruses to replicate in mice and ferrets as an additional safety measure In mice, the vaccine viruses replicated in the respiratory tract but did not spread to the animals’ brains. In ferrets, the H5N1 vaccine viruses did not replicate in the lungs or the brain.

To evaluate the protective ability of the vaccines, the researchers gave the mice a single dose of vaccine virus via nose drops. All of these mice survived infection with the 1997 and 2004 H5N1 wild-type viruses, including two more recent strains of the H5N1 virus found circulating in Vietnam and Indonesia in 2005. Further, mice that received a second dose of vaccine 28 days after the initial inoculation demonstrated a stronger and more rapid immune response and almost complete protection from respiratory infection when exposed to the naturally occurring H5N1 viruses. Ferrets exhibited similar results when given two doses of the vaccine viruses.

“It is impossible to predict how the H5N1 virus will evolve or which strain, if any, will cause an influenza pandemic. To be prepared, we need to select a vaccine capable of inducing an effective human immune response against a range of H5N1 viruses that may emerge in the future. This study shows that such cross-protection can be achieved in small animals,” says Dr. Subbarao. “The next step is to evaluate in people the safety and immune response induced by these vaccines to see if they produce cross-reactive antibodies that are likely to protect against different H5N1 viruses.”

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.

The concept of using cold-adapted flu viruses to create flu vaccines, as detailed in the study in PLoS Medicine, was developed by scientists at NIAID and the University of Michigan School of Public Health (http://www3.niaid.nih.gov/news/focu...ion/flumist.htm).

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov. 

__________________ 

"When someone loves you, the way they say your name is different. You just know that your name is safe in their mouth."
Billy - age 4

stephanie

 

Two years ago this month (U.S.); WHERE WE WERE THEN:

WHERE WE ARE NOW:

So the U.S. currently has enough H5N1 vaccine (of questionable effectiveness) stockpiled for the military and 4 million lucky people out of a population of approximately 300 million, and we are among the better prepared....


 

More about the promising Glaxo low dose vaccine (something to watch):


 

http://www.futurepundit.com/archives/003728.html

 

http://medicine.plosjournals.org/pe...al.pmed.0030360

Promising Preclinical Results With Live Attenuated Avian Flu Vaccines 

more about using current facilities for new cell vaccines:

http://www.medicalnewstoday.com/med...hp?newsid=51953

 

Without more information it is not possible to determine how solid Lash's recommendations are.

1. He says the U.S. can currently make 250 to 300 million doses of pandemic flu vaccine in 6 months. How much vaccine is he figuring in each dose? Last year it was estimated that the one vaccine producing plant in the U.S. could turn out approximately 20 million flu doses per month.

I had always assumed that those were three-way flu doses; 15 mcg. of vaccine per strain of flu (3x15), for a total of 45 mcg. per dose. However, in almost three months of flat out Vietnam 2004 H5N1 vaccine production for the U.S. stockpile, approximately 10 million vaccine doses of 90 mcg. each, were made last September to January (when the plant was not tied up with annual flu vaccine production). That would be the equivalent of 20 million 45 mcg. doses of vaccine, or 60 million 15 mcg doses of vaccine in approximately 3 months. It looks like the current U.S. vaccine production capacity is approximately 20 million 15 mcg. doses of vaccine per month.

If 20 million doses of vaccine at 15 mcg. per dose can be made in a month, then 120 million doses of 15 mcg. vaccine could be made in 6 months. If each dose of H5N1 vaccine contained only 7.5 mcg. of vaccine, then 240 million doses could be made in 6 months, etc. So how many mcg. of H5N1 vaccine per dose is Lash hypothesizing?

2. Lash also says, "With research into different processes for purifying the vaccine, it would not be necessary to renovate facilities". Plans are already underway to renovate and expand existing facilities and build new ones. How long will research into different processes for purifying the vaccine, etc., take?

While Lash may have some good ideas, I think he is about a year late. The U.S. and other nations, as well as drug companies, have already invested hundreds of millions of dollars in vaccine facility expansion and construction. Money that can't be unspent, and plans that will not be delayed.


 

Initial human trials of bird flu vaccine in Russia a success
RIA Novosti - 16:09 | 25/ 09/ 2006

ST. PETERSBURG, September 25 (RIA Novosti) - The first Russian trials of a human vaccine against the H5N1 bird flu virus was a success, a Russian research institute member said Monday.

Marina Yerofeyeva, a lab head at a research center specializing in flu viruses, said three of the six tested versions of the vaccine proved successful, and researchers will now select the most appropriate one.

"There will be two assessment criteria," Yerofeyeva said. "The first is vaccine safety, i.e. volunteers' response to a vaccine in question. The other criterion is the number of immune bodies a vaccine produces in volunteers' blood tests."

Three versions of two types of the vaccine were tested on six groups comprising 20 volunteers each, and none of the volunteers complained of complications or serious disorders after they were injected with the serum, Yerofeyeva said.

Yerofeyeva said two or three vaccine versions will be tested on larger volunteer groups of about 100 people in the next stage of the effort against the disease. Scientists fear the virus could mutate into a form transmissible between humans, sparking a global pandemic.

The disease has spread worldwide since it was first spotted in Asia in 2003, and has claimed dozens of human lives. No human fatalities have been reported in Russia.

This year, an epidemic of the deadly virus broke out in five Siberian and 11 southern regions, resulting in the deaths and culling of about 1.5 million birds.

Several research centers will be involved in the second phase, and commercial production of the vaccine can begin after its completion, the researcher said.

"I believe the problem will be resolved, and that vaccine production will be launched by next spring," Yerofeyeva said.

She said the vaccine is likely to be given mainly to people in high-risk groups, including poultry farm workers, hunters and veterinary workers.

Seems the Chinese and the Russians are both on track for 2007/2008. 

Public release date: 25-Sep-2006

NIH/National Institute of Allergy and Infectious Diseases

H9N2 avian flu vaccine paired with adjuvant provokes strong human immune response at low doses.

When combined with an immune-boosting substance called an adjuvant, low doses of an experimental vaccine against a strain of avian influenza (H9N2) provoked a strong antibody response in human volunteers, report scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The clinical trial of 96 adults was conducted at the NIAID-supported Viral Respiratory Pathogens Research Unit at Baylor College of Medicine, Houston, and was led by Robert L. Atmar, M.D. The results are now online in Clinical Infectious Diseases.

"The results of this clinical trial add to the growing body of information demonstrating the potential value of adjuvanted avian influenza vaccines," says NIAID Director Anthony S. Fauci, M.D. An adjuvant is a substance that is added to a vaccine to boost the body's immune response to the vaccine's antigen. "In the event of an influenza pandemic, adjuvanted vaccines could provide a way to extend a limited vaccine supply to more people," he adds.

In 1999, two children in Hong Kong became infected with H9N2, a strain of avian influenza that had not previously been detected in humans. Humans have little or no natural immunity to a virus--such as H9N2 or the more deadly H5N1 avian influenza--that historically has circulated only in birds. If H9N2 or H5N1 were to acquire the ability to spread easily from person to person, an influenza pandemic could result, health experts say.

In 2004, NIAID directed Novartis Vaccines and Diagnostics (formerly Chiron Corporation) to produce 40,000 doses of an experimental H9N2 vaccine at its vaccine manufacturing facility in Siena, Italy. Some of the vaccines were formulated with Novartis's MF59 adjuvant. (See http://www3.niaid.nih.gov/news/news...s/2004/h9n2.htm.)

Dr. Atmar and his colleagues tested the vaccines in volunteers aged 18 to 34 in this Phase I clinical trial. Phase I vaccine trials assess candidate vaccines' safety and ability to stimulate an immune system response, and are not designed to determine whether the vaccine would prevent infection by naturally occurring virus. The researchers vaccinated 48 volunteers with non-adjuvanted H9N2 vaccine (made from inactivated virus) at one of four dosages--3.75, 7.5, 15 or 30 micrograms. An additional 48 volunteers received MF59-adjuvanted vaccine at one of the same four dosages. Volunteers were vaccinated twice, with inoculations spaced 28 days apart.

An avian flu vaccine, like the seasonal flu vaccine, should stimulate antibodies, which help ward off infection if the vaccinated person later encounters the flu virus. In general, the higher the level of antibodies made in response to a vaccine, the more protective the vaccine is, Dr. Atmar notes.

"In our trial, a single inoculation of adjuvant-containing H9N2 vaccine, even at the lowest dosage, generated a good antibody response," says Dr. Atmar. By comparison, the seasonal flu vaccine contains 15 micrograms each of three different circulating flu strains--much higher than the 3.75 micrograms of H9N2 flu virus contained in the lowest dose vaccine tested in this trial. Furthermore, he adds, a single dose of the adjuvanted H9N2 vaccine was as good as two doses of the vaccine without adjuvant.

Currently, MF59 is licensed for use as a vaccine adjuvant in Europe but not in the United States. The results of this trial, says Dr. Atmar, suggest that MF59 is deserving of further study.

http://www.eurekalert.org/pub_relea...a-haf092506.php

http://www.clinicaltrials.gov/ct/sh...0380237?order=1 

Sanofi pasteur Broadens Pandemic Preparedness With First Clinical Trial of Novel Cell-Based H7N1 Vaccine
Tuesday September 19, 9:14 am ET


LYON, France, Sept. 19 /PRNewswire-FirstCall/ -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, has within the framework of FLUPAN, a collaborative research project funded by the European Commission, generated the first clinical trial lot of a new generation of H7N1 pandemic vaccine. This trial will broaden sanofi pasteur's pandemic preparedness program initiated with the development of H5N1 vaccines

The H7N1 vaccine was produced at sanofi pasteur's Marcy l'Etoile facility in France using the PER.C6® cell-based technology from its partner CRUCELL N.V., allowing an alternative production process expected to offer advantages over traditional manufacturing methods.

This phase I clinical trial, initiated today in Bergen, Norway, is the first to assess the safety and ability to generate an immune response of a split, inactivated prototype pandemic H7N1 vaccine produced on cells.

[full article]:
http://biz.yahoo.com/prnews/060919/nytu029.html?.v=68 

Sanofi pasteur Cell Culture-Based Seasonal Influenza Vaccine Enters First Clinical Trial


SWIFTWATER, Pennsylvania & LYON, France, September 26 /PRNewswire/ --

- Flu Vaccine Based on New Technology Within U.S. Government Preparedness Program

Sanofi pasteur, the vaccines business of the sanofi-aventis Group (NYSE: SNY), initiated its first clinical study today with a new generation of seasonal influenza vaccine produced using cell culture technology. This trial represents one of the company's initiatives to diversify flu vaccine manufacturing technologies.

The trial conducted in the United States is part of a contract awarded by the U.S. Department of Health and Human Services (HHS) to accelerate the development of a new cell culture-based influenza vaccine.

"This trial will assess the safety and ability to generate an immune response of a cell culture-based vaccine that could provide an important alternative to traditional egg-based flu vaccines," said Dennis Morrison, MD, Clinical Investigator at the first trial site, Bio-Kinetic Clinical Applications, Inc. in Springfield, Missouri. The clinical study is the first step toward Sanofi pasteur filing a Biologics License Application with the Food and Drug Administration (FDA) to support development of a cell culture-based trivalent split inactivated seasonal influenza vaccine.

The phase I clinical trial will be conducted on 100 healthy adults, 18-64 years of age. Half of the study participants will receive the cell-based vaccine and the other half a traditional egg-based control vaccine. "We are pleased to participate in a study that evaluates next-generation influenza vaccines," said Cynthia Strout, MD, Clinical Investigator at the second trial site, the Coastal Carolina Research Center in Mt. Pleasant, South Carolina.

This vaccine was developed using PER.C6(R) cell culture technology, licensed from Dutch biotechnology company, Crucell N.V. Cell culture technology could allow Sanofi pasteur to diminish dependence on eggs while offering a reliable production technology.

The production scale potential of the PER.C6 cell line has been demonstrated in a successful bioreactor run of 20,000 litres. This project breaks new ground in vaccines technology by demonstrating effective large scale production capacity using cell culture on a commercial scale. This scale-up process was achieved under a subcontracting agreement between sanofi pasteur and Lonza Biologics plc, a biotechnology contract manufacturer and subsidiary of the Lonza Group.

[full article]:
http://www.prnewswire.co.uk/cgi/news/release?id=179919 

Interesting development, will take some years for clinical trials


'Protecting virus' offers instant flu protection & converts flu infections into their own vaccines

Published in M2 PressWIRE on Wednesday, 04 October 2006 at 09:42 GMT
Copyright (C) 2006, M2 Communications Ltd.

Research led by Professor Nigel Dimmock at the University of Warwick is developing an entirely new method of protecting against flu. This has been shown to protect animals against various strains of flu, and could offer protection against the full range of influenza A infections, including H5N1 and any new pandemic or epidemic strains infecting humans. The 'protecting virus' provides instant protection, and completely prevents flu symptoms developing by slowing influenza infection rates to such an extent that the harmful infection becomes a vaccine against that very form of influenza. It can also counter an actual infection and offer protection if given up to 24 hours after first infection (and possibly longer).

Existing vaccination methods depend on stimulating the body's immune system, so that white blood cells produce antibodies that attach to the surface of the virus and start the process of killing it. This works well for many diseases, such as smallpox, polio and measles, but is much less effective with influenza, as the coat of the flu virus is continually changing. Vaccination against one strain of flu, for instance H3N2, is totally ineffective against another, such as H5N1. This is especially problematic when a new pandemic strain emerges, as all existing vaccines are likely to be totally ineffective.

Professor Dimmock has spent more than two decades investigating an entirely new method, that uses a 'protecting virus'. This has now been shown to provide instant protection against all flu symptoms and to slow the development of an influenza infection to such an extent that harmful infections are transformed into a vaccine against that form of influenza.

'Protecting virus' has a significant alteration to one of the virus's genes. The genetic material of a flu virus consists of 8 individual segments of single stranded RNA. Professor Dimmock's protecting influenza virus has a huge but specific deletion of around 80% of the RNA of one of these 8 strands.

This deletion makes the virus harmless and prevents it from reproducing by itself within a cell, so that it cannot spread like a normal influenza virus. However, if it is joined in the cell by another influenza virus, it retains its harmless nature but starts to reproduce - and at a much faster rate than the new influenza virus. This fast reproduction rate - spurred by the new flu infection - means that the new invading influenza is effectively crowded out by the 'protecting virus'. This vastly slows the progress of the new infection, prevents flu symptoms, and gives the body time to develop an immune response to the harmful new invader. In effect the protecting virus converts the virulent virus into a harmless live vaccine.

Research indicates that the 'protecting virus' would have the same beneficial effect whatever strain of influenza is infecting you. This is because the coat of the virus is irrelevant to the protection process - the effect works on the virus genes inside the cell. It thus promises to be a highly effective tool when combating the spread of any new strain of virus, as well existing strains. One could give it as a preventive measure without the need to tailor it to a particular flu strain or mutation. This has obvious benefits when dealing with the sudden outbreak of a major epidemic, as one would not need to know the exact make up of the new strain before deploying the protecting virus making it much more useful than vaccines, which are effective only against particular existing strains of virus. In addition it protects instantly, whereas protection generated by conventional flu vaccination takes 2-3 weeks to become fully effective. Experiments so far show that a single dose of protecting virus can be given 6 weeks before an infection with flu virus and be effective. This could also have a substantial advantage over anti-viral drugs that only give less than 24-hour protection. Another advantage is that influenza virus does not appear to become resistant to 'protecting virus', although drug-resistance is a serious problem with many microbes.

'Protecting virus' also protects when given up to 24 hours after infection (and possibly longer). It is thus able to counter an actual infection. It could therefore also be used as a treatment for family and other direct contacts of infected individuals.

'Protecting virus' is easy to administer as it targets the same cells as any other flu virus and uses the same method to enter the cell. Laboratory work to date has used a drop of saline containing the protecting virus, squirted up the nose. Aerosol administration, used already for some vaccines, would be another way and is more user-friendly than injections.

The protecting virus could also be a useful treatment for domestic animals. Ducks get a gut infection and chickens a combined gut and respiratory infection, so it may be possible to simply deliver the protecting virus to them in their drinking water. One dose should protect a chicken for weeks. Flu is a major problem in the horse racing industry and in domestic horses. It also has very recently become a problem in domestic dogs in the USA and domestic cats are susceptible to H5N1 virus.

The Warwick research team has now filed a patent on the protecting virus and they are exploring ways of taking 'protecting virus' through human clinical trials and testing on birds. The University has established a company - ViraBiotech - to help advance those aims. This may involve venture capital support, and collaborations with pharmaceutical companies, to enable this novel technology to be rigorously tested in a wide range of animals and humans, and using a wide range of influenza strains.

Note for editors: In normal circumstances the University would not press release research that has not been fully published (although all the preliminary work has been published in internationally acclaimed, peer-reviewed scientific journals), or tested on birds and humans, until such milestones had been passed. However given the current heightened global concern about the risks of influenza outbreaks the University thought it was important to alert people to this research at the earliest opportunity to enable the researchers to find support to allow early human trials and bird testing

http://www.m2.com/m2/web/story.php/...02571FD002E6077 

Same subject, different article, but considering the claims and the source, I thought I'd post it despite the dupfactor.

Breakthrough may mean end to flu misery for millions, says scientist
Yorkshire Today - 04 October 2006

Chris Benfield
Science and Technology Correspondent
Science may have come up with a way to stop flu.

Warwick University professor Nigel Dimmock has spent 20 years looking for a general antidote to flu viruses and says he is now ready to make one on a large scale.

He is sure it would work against H5N1 – the new strain of bird flu which has been causing worldwide concern – and its variants.

And he is ready to start trials on humans, farm chickens and other animals governments and businesses might want to protect.

The university is launching a company in which it and Prof Dimmock have a stake, ViraBiotech, to raise money for trials and preparations for manufacture.

In theory, a human flu-preventer based on the Warwick discoveries could be ready in three years.

It would not wipe out flu viruses, but it could stop the epidemics which disrupt economies and cost lives when a virus mutates and spreads suddenly.

It could also prevent run-of-the-mill misery and cost arising from the 144 viruses already established in humans and animals such as pigs, poultry and horses.

Prof Dimmock's method promises to work against all viruses in the Influenza A category – the family which causes most trouble – and it might also work against some Influenza B.

It involves "protective viruses" – incomplete imitations of a full flu virus, which occur naturally along with the viruses they mimic.

Nobody knows what they are for, in evolutionary terms, but one theory is that, by competing for resources, they stop the damaging virus from killing its host too quickly.

Prof Dimmock, 66, is an expert on what happens when a protective virus gets into a host before the real thing.
On its own, it cannot reproduce, because there is a bit missing from one of its strands of RNA, the genetic material which carries the codes for building cells.

When a real virus arrives, they team up and both reproduce, but the dummy virus works faster, because it is smaller. It swamps the "nasty" version, so the body can develop antibodies before damage is done.

Prof Dimmock has seen the process in laboratory cultures, mice and ferrets. A dose is effective for six weeks and should cost no more than existing vaccines and anti-viral drugs.

He now has a protective virus from the Influenza A family which he can reproduce consistently and check for quality. But he stresses that genetic modification is not involved.
"It is a naturally occurring product," he said yesterday.

The system could lead to similar medicines against colds, hepatitis and other viral illnesses.

An independent expert, John Oxford, head of virology at three London hospitals, said the idea had "huge potential". 

Baxter says bird flu vaccine safe in early trial

Wed Oct 4, 2006 1:36 PM BST

CHICAGO (Reuters) - Baxter International Inc. said on Wednesday preliminary results from an early trial of its vaccine for pandemic bird flu using modern cell-based manufacturing techniques suggest the vaccine is safe and well tolerated.

The clinical trial of the experimental H5N1 pandemic vaccine in 270 healthy adults in Austria and Singapore suggest the vaccine has similar side effects to those reported for seasonal flu vaccines, the company said.

"This is the first clinical demonstration that a candidate H5N1 vaccine can induce antibodies that neutralize widely divergent strains of H5N1," said Noel Barrett, vice president of Global research and development for Baxter's vaccines business.

"These preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic," he said in a statement.

The company plans to begin a late-stage clinical trial of the vaccine early next year.

http://today.reuters.co.uk/news/art...lth-C4-Health-4 

Posted by Christian on Russia thread. I post it also here because can be important for vaccine thread.

http://www.curevents.com/vb/showpos...41&postcount=23

 

INTERVIEW - China to start 2nd trial for bird flu vaccine soon
Reuters AlertNet - 12 Oct 2006 08:14:54 GMT

By Tan Ee Lyn
BEIJING, Oct 12 (Reuters) - A Chinese company that is developing a H5N1 bird flu vaccine for humans plans to kick off a second clinical trial before the end of the year and will have its production capacity expanded ten-fold by mid-2007.

"The second clinical trial should be over by July or August next year, just before the flu season begins," Yin Weidong, managing director of state-backed Beijing Sinovac Biotech Co., told Reuters in an interview on Thursday.

He tried to ease concerns over using a strain of the virus found in Vietnam in the vaccine, saying it would offer some protection against other H5N1 strains.

The company needs to obtain the approval of the State Food and Drug Administration (SFDA) for the second trial and will file its application with the agency within the next two weeks.

"The government values this project very highly and it will get going faster," Yin said. He added that the World Health Organisation had provided advice in the first clinical trial and would probably do so again in the second trial.

Sinovac ran its first clinical trial involving 120 volunteers in Beijing this year.

It published its findings in The Lancet medical journal in September, saying the experimental vaccine was effective and well tolerated at low doses.

It used whole-virus vaccine in 1.25, 2.5, 5 and 10 microgram amounts, but the 10 microgram dose was found to be most effective in producing an immune response.

The volunteers, aged between 18 and 60, did not suffer serious side effects, but some experienced pain, swelling and fever.

The second trial will have a wider age limit, taking in people below 18 and over 60, but Yin said the drug administration would make the final decision.

Apart from Beijing, Sinovac will look for volunteers in two other cities, most likely in southern China. There will be two dosages: 5 and 10 micrograms.

By mid-2007, Sinovac will have expanded its production capacity to 20 million doses from a current 2 million, but when the vaccine goes into production will hinge on how soon it secures orders.

Sinovac and several companies around the world are in a race to develop a vaccine to combat what experts fear would be a flu pandemic triggered by the H5N1 bird flu virus, which has killed 148 people since late 2003.

Although it remains a disease among birds, scientists say it could wreak havoc and kill millions if it mutates and learns to transmit efficiently among humans.

Some experts, however, question the rationale behind designing these "pre-pandemic vaccines" based on a H5N1 strain found in Vietnam in recent years, saying they might not protect against other H5N1 strains and the eventual pandemic strain.

At least two other H5N1 strains have become geographically more widespread; with one spreading across not only Asia, but parts of Europe, Africa and the Middle East.

But Yin said there should be some amount of cross protection
"Even though the virus is changing, it is still H5N1. We are facing one enemy," he said. . 

Updates on Pandemic Flu Vaccine Trials to be Presented at 44th Annual IDSA Meeting
National Institutes of Health - Thursday, October 12, 2006

Preliminary results from clinical trials testing two different pandemic flu vaccine approaches — one a prime-boost strategy using different subtypes of H5N1 vaccines, the other an H5N1 vaccine delivered into the skin (intradermal) rather than the muscle — will be presented at the 44th Annual Meeting of the Infectious Diseases Society of America being held in Toronto Oct. 12-15. The presentations are scheduled for a late-breaker session on Friday afternoon, Oct. 13th.

Funding for the trials comes from the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. Reporters may call the NIAID News Office at 301-402-1663 to speak with NIAID Director Anthony S. Fauci, M.D., who is available to comment and provide perspective on these preliminary findings.

Preliminary Results Suggest Priming Boosts Immune Responses to Variant H5N1 Vaccine

Presentation time: Late-Breaker Session, Friday, Oct. 13, 2006, 5:00 p.m.
Presenter: Nega Ali Goji, M.D., University of Rochester Medical Center, Rochester, NY

If a pandemic influenza strain was identified, it would likely take several months to make a vaccine against it, and stimulating protective immunity with the vaccine would likely require more than one dose. Giving people two doses of H5N1 influenza vaccine as a pandemic is evolving would be logistically difficult, however, so researchers have been urgently investigating alternative strategies.

One such alternative is to prime people ahead of time with a related vaccine so that only a single dose of vaccine is required when the pandemic emerges. A team of researchers led by University of Rochester Medical Center investigators Nega Ali Goji, M.D., and John J. Treanor, M.D., recently tested this hypothesis. They compared the immune response to a single 90-microgram dose of one variant of avian flu vaccine in two groups of adults: those who had received a different variant of H5N1 avian flu virus vaccine some eight years earlier and those without pre-exposure to any H5N1 virus or vaccines.

In late 1997-98, soon after the first case of direct bird-to-human transmission of an H5N1 flu virus occurred in Hong Kong, NIAID funded the production of an experimental vaccine made from the Hong Kong virus and tested it in a small clinical trial conducted at the University of Rochester in healthy adults (see reference). Thirty-seven individuals who received two doses of the Hong Kong H5N1 vaccine in that trial served as the “primed” population in the current study.

The booster dose in the current study — an experimental inactivated H5N1 virus vaccine produced for NIAID by sanofi pasteur, the vaccines business of the sanofi-aventis Group of Paris — is based on an H5N1 flu virus from Vietnam. The Hong Kong virus is related to the Vietnam virus but belongs to clade 3, which refers to its branch on an evolutionary tree of the H5N1 viruses in Asia, while the Vietnam virus belongs to clade 1.

In their trial, the Rochester team found that more than twice as many of the individuals who had received the priming dose of clade 3 H5N1 vaccine responded with substantial antibody levels to a single dose of clade 1 H5N1 vaccine than did those with no prior H5N1 exposure. Dr. Treanor says that these early but promising data indicate that priming with an antigenic variant vaccine before a pandemic occurs may be one strategy used to help control a pandemic.

“These preliminary findings need to be confirmed in larger studies, but they offer the intriguing possibility that pre-pandemic priming with existing H5N1 vaccines may boost the immune response to a different H5N1 vaccine tailor-made years later to thwart an emerging human influenza pandemic,” says Dr. Fauci.

Third Dose of Intramdermal H5N1 Vaccine Well-Tolerated but does Not Improve the Immune Response

Presentation Time: Late-Breaker Session, Friday, Oct. 13, 2006, 5:15 p.m.
Presenter: Shital M. Patel, M.D., Baylor College of Medicine, Houston, TX

Previous studies have suggested that lower dosages of seasonal flu vaccine given intradermally may work as well as higher dosages of the same vaccine given intramuscularly, enabling public health officials to “stretch” available doses of vaccine in a time of shortage. To test this principle with an H5N1 pandemic flu vaccine, NIAID initiated a vaccine trial to compare immune responses generated by an H5N1 vaccine given by the intradermal or the intramuscular route. The H5N1 vaccine formulations were produced for NIAID by sanofi pasteur.

Wendy Keitel, M.D., Shital M. Patel, M.D., and their Baylor College of Medicine colleagues conducted the trial. Results of their initial two-dose study among 100 participants indicated that antibody responses among volunteers given 3 or 9 micrograms of vaccine intradermally were similar to the antibody responses seen among volunteers given 15 micrograms intramuscularly: 4 percent, 5 percent, and 12 percent of volunteers, respectively, had a significant increase in antibody levels after two doses. Those given 45 micrograms by the intramuscular route, however, showed a significantly higher response rate: 56 percent of volunteers in this group responded.

In the current study, the Baylor team enrolled 77 healthy adults between the ages of 18 and 40 who had previously received two doses of the same vaccine one month apart and gave them a third dose of vaccine 6 months later to see if it boosted their antibody response. The participants, again divided into four groups, received either 3 or 9 micrograms intradermally or 15 or 45 micrograms intramuscularly. The dosages of vaccine were limited by the formulations available.

According to Dr. Patel, a quarter or less of the participants in the study groups given the vaccine intradermally or intramuscularly at 15 micrograms had a significant antibody response after the third dose, while nearly two-thirds of the volunteers in the group that received 45 micrograms intramuscularly had a similar response. For each dosage by either route of administration, the results show that giving a third dose of the vaccine 6 months later increased antibody titers to levels similar to those achieved after the first two doses.

“This small pilot study demonstrates that multiple doses of an inactivated H5N1 vaccine given by either the intradermal or the intramuscular route are safe and well tolerated,” says Dr. Fauci. “It also provides a strong rationale for testing higher dosages of H5N1 vaccine given intradermally.” Plans are under way to directly compare the immune responses generated by vaccinating either into the skin or into the muscle with an H5N1 vaccine containing higher levels of the same amount of antigen.

NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The National Institutes of Health (NIH) — The Nation's Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Reference: JJ Treanor et al. Safety and immunogenicity of a recombinant hemagglutinin vaccine for H5 influenza in humans. Vaccine 19, 1732-37 (2001). 

H5N1 clinical trials
From Wikipedia, the free encyclopedia
H5N1

H5N1 clinical trials are clinical trials concerning H5N1 vaccine; which is to say they are investigations concerning H5N1 vaccine in humans intended to discover pharmacological effects and identify any adverse reactions.[1]

Contents

1 Current Status of H5N1 Candidate Vaccines
2 Individual studies
2.1 Revaccination - January 2006
2.2 A/H5N1 in adult - February 2006
2.3 H5 booster after two doses - June 2006
2.4 H5 in the elderly - August 2006
2.5 H5 in healthy adults - November 2006
2.6 Bird flu - November 2006
2.7 Pandemic flu - January 2007
2.8 Children - February 2007
3 See also
4 Sources
5 Further reading

[edit]

Current Status of H5N1 Candidate Vaccines

http://en.wikipedia.org/wiki/H5N1_clinical_trials 

Sanofi bird flu vaccine may offer wider protection

Wed Oct 18, 2006 1:55 PM BST

PARIS (Reuters) - French drug maker Sanofi-Aventis said on Wednesday tests on its experimental H5N1 bird flu vaccine show it offers protection against more strains of the virus than initially thought.

"These encouraging results show the capacity of a pre-pandemic vaccine to offer broad protection by inducing the formation of antibodies capable of neutralizing the most recent strains of the H5N1 virus," Sanofi said in a statement before a bird flu conference in Vienna.

It said the strains included those that appeared in Turkey and other eastern European countries in 2005 and 2006 and which continue to circulate in southeast Asia.

Sanofi has signed several contracts with governments in Europe and the United States in order to produce a bird flu vaccine in case of a worldwide pandemic. France will also buy 1.4 million doses of the vaccine that has already been tested.

http://today.reuters.co.uk/news/art...TIS.xml&src=rss

Vaccin planned ready in 2009: we'll see then... 

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