Chinese vax - Another vaccine sales pitch ?

[Mingus]

Thanks to Lyro of the French FT forum


Machine translated
CHINA - Vaccine in preparation
--------------------------------------------------------------------------------
The CHINESE VACCINE AGAINST the AVIAN FLU
AT the MAN SURE AND EFFECTIVE
August 28, 2006 (according to Xinhua Net)
the preliminary clinical trials of the Chinese vaccine against the avian flu at the man showed that this vaccine was sure and effective, to Monday with Beijing the researchers announced.
Beijing Sinovac Biotech Co. and the national Center of control and prevention of diseases published the results of the first phase of the clinical tests of the vaccine which they jointly developed.
Six volunteers took part in these tests carried out between November 2005 and on June 6, 2006 at the Hospital of the China friendshipJapan with Beijing.
Source: www.china.org.cn/french/256616.htm

[Mingus]

Re: The Chinese human vaccine against bird flu is effective and safe

http://www.pharmalive.com/News/Index...ticleid=368122

Preliminary Result of Phase I Clinical Trial Shows That Sinovac's Pandemic Influenza Vaccine (H5N1) has High Safety and Immunogenicity Profile



BEIJING, Aug. 28, 2006 /Xinhua-PRNewswire/ -- Sinovac Biotech Ltd. , 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 the 120 volunteers and it is proved that the vaccine is well tolerated and immunogenic.


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.
About Pandemic Flu
Signs of a possible pandemic flu have emerged in Southeast Asia, as lethal infections in poultry and humans, and infections of the H5N1 influenza virus strain continue to be reported. While there is no confirmed evidence of human-to-human transmission, there have been suspected cases identified in Indonesia in May 2005. It is feared that if the H5N1 influenza virus undergoes either a genetic alteration or recombination with a human influenza virus, a new subtype could emerge which could be both highly contagious and highly lethal in humans. Such a subtype could potentially cause a global influenza pandemic.
Most health officials estimate a flu pandemic could last a year or more, and millions of lives could be at risk. It is believed that one of the most effective countermeasures against pandemic flu is to manufacture mass quantities of vaccines as quickly as possible.
About Sinovac
Sinovac Biotech Ltd. is a Chinese biopharmaceutical company, focused on research, development and commercialization of vaccines designed to combat human infectious diseases. Sinovac's vaccines include Healive(TM) (hepatitis A), Bilive(TM) (hepatitis B) and Anflu(TM) (influenza). Sinovac has vaccines in clinical trials to combat avian influenza (bird flu) and SARS.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

[sharon sanders]

Re: The Chinese human vaccine against bird flu is effective and safe

Annoucement - PR Newswire is an advertising newsletter. It is bought and paid for by companies that have something to sell.

There is no verification that this vaccine is effective.

Thank you Mingus for bringing this situation to the forefront.

[Mingus]

Re: The Chinese human vaccine against bird flu is effective and safe

You are right in stating that the effectiveness and safety proof of this vaccine are weak (6 volunteers).
PRNewswire is a "pub"-like site but the story haved also been lauch by Xinhua wich is the govnt-backed news agency of china.

How can we understand this story who is spreading worldwide in the internet ?
I personnaly see it as a china's will to present his nation-based scientific effort to prepare china to the pandemic and to show some "effectiveness" of his scientific-community.
What is the real effectiveness of this vaccine, few one knows it and many political trick may be involved inside china as well.

I understand this as a vax only intended for "internal" china's use but I may be wrong.

But for sure, as a PRNewswire communiqué, they must look fo financing of something... ?

See the same as presented on others news.

____________

http://www.kfmb.com/story.php?id=61343
China: Tests Find Bird Flu Vaccine Safe
Last Updated:
08-28-06 at 7:38AM
BEIJING -- A Chinese-developed vaccine against the H5N1 strain of bird flu in humans has been found safe in the first round of tests, a government news agency reported Monday.

Researchers began work on the vaccine last year, and the government said it was ready to start mass production. But any vaccine would face more tests before it could be approved for human use.

Tests were conducted on six human volunteers at a Beijing hospital between November and June, the official Xinhua News Agency said.

Researchers said the vaccine "proved initially safe and effective," the official Xinhua News Agency reported. It gave no other details of the results, or of any plans for more testing.

The tests were conducted by the China Center for Disease Control and Prevent and a Chinese drug company, Beijing Sinovac Biotech Co., according to Xinhua.

Chinese authorities say the vaccine is meant for high-risk groups such as poultry workers.

The U.S. National Institute of Allergy and Infectious Diseases is also conducting trials on an H5N1 vaccine for humans.

China has suffered 14 human deaths from the H5N1 strain of flu _ the latest a farmer who died July 12 _ and dozens of outbreaks among its vast poultry flocks.

Experts fear the virus could mutate into a new strain that could spread easily from human to human, potentially causing a global pandemic.

[sharon sanders]

Re: Another vaccine sales pitch

Thanks Mingus for your detective work.

[Mingus]

Re: Another vaccine sales pitch

Notting new in this one but it is from associated press

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20060828/china_bird_flu_vaccine_060828/20060828?hub=Health
Tests suggest bird flu vaccine is safe: China

Updated Mon. Aug. 28 2006 8:41 AM ET
Associated Press
<!-- dateline -->BEIJING<!-- /dateline --> --

and this one from United Press International where a business plan is showed ?

http://www.upi.com/HealthBusiness/view.php?StoryID=20060828-092626-7419r
Sinovac's flu vaccine shows promise

BEIJING, Aug. 28 (UPI)
(...)
Sinovac also said it will expand its vaccine manufacturing plant so it has the capability to produce 20 million doses of Panflu per year. The project is expected to be completed in 2007.

[hawkeye]

Re: Another vaccine sales pitch

India develops avian flu vaccine for less than a cent
HLT-INDIA-AVIAN FLU-VACCINE
India develops avian flu vaccine for less than a cent

NEW DELHI, Aug 28 (KUNA) -- A vaccine to prevent avian flu developed by a research institute in Central Indian city of Bhopal could be available for less than a cent per dose, for the country's farmers who have been affected by the epidemic.

Developed by the High Security Animal Disease Laboratory (HSADL) in Bhopal, it is the first vaccine against avian flu in the country.

"The Indian Council of Agricultural Research (ICAR) entrusted us with the job of developing the vaccine soon after the first outbreak of the disease this February and also provided us with 80 million Indian Rupees (Some USD 1.

77 million) promptly to help us accomplish the challenging task," news agency Indo-Asian News Service (IANS) reported Monday quoting HSADL Joint Director H K Pradhan.

HSADL, which acquired the technique for identifying the avian influenza virus among poultry, tested thousands of bird samples, including droppings of migratory birds, after avian flu (H5N1) affected parts of Indian states of Madhya Pradesh, Gujarat and Maharashtra earlier this year.

India suffered losses estimated at USD 150 million with over one million bird culled and about 1.5 million eggs as well as several thousand tones of feed destroyed. There were however no human casualties from the epidemic.

"The cost of the vaccine has been worked out at 27 paise per dose (one Paisa is equivalent to 1/100th Rupee). It is expected to go up to 35 paise, including the trader's profit and cost of transportation. But it will be for the company manufacturing the vaccine to decide on the selling price," Pradhan told IANS in an interview.

"We had the viruses collected during this year's outbreak and the cell lines taken five years ago," said Pradhan.

"The vaccine can be used immediately after an outbreak to control the spread of the virus as well as for vaccination in anticipation of an outbreak, " he added.

"However, vaccination before an outbreak is generally not advisable as the vaccine has its own limitations. But there is little chance of bird flu occurring after vaccination as the vaccine uses a killed virus to elicit good immune response," Pradhan said.

"The immune response is good and the protection offered by the vaccine has been found to be above 90 percent. The duration of protection should last up to six months for hens. For a broiler it needs to be administered only once," he told the news agency. (end) dr.

[Mingus]

Re: Another vaccine sales pitch

The original Xinhua press release

http://news.xinhuanet.com/english/20...nt_5015902.htm
Chinese human bird flu vaccine tests safe, effective


www.chinaview.cn 2006-08-28 11:28:20


BEIJING, Aug. 28 (Xinhua) -- Preliminary clinical tests show that a bird flu vaccine for human use developed by Chinese researchers is safe and effective, researchers said on Monday.

The vaccine was jointly developed by China's Ministry of Science and Technology, Center for Disease Control and Prevention and Beijing Sinovac Biotech Co., a Beijing-based pharmaceutical company.

They said on Monday that the first phase of clinical trials has proved the vaccine is safe and effective for humans.

Six volunteers took part in the clinical tests last November at the Beijing China-Japan Friendship Hospital, after the State Food and Drug Administration granted the vaccine developers the green light for clinical trials.

Results from the first phase trails, which ended in June, showed that the four antigens worked at different levels in stimulating the production of antibodies, according to the company.

It 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.

The 120 participants who were vaccinated have shown no serious adverse reactions, researchers said. Blood tests and urine tests all indicate that the vaccine is safe for human use.

The vaccine was developed from the virus's NIBRG-14 strain which was provided by the World Health Organization (WHO) and protects against the deadly H5N1 strain of avian influenza.

The vaccine can be mass produced, according to researchers.

Beijing Sinovac Biotech Co. said it is ready to apply for the second phase of clinical trials

In China, a vaccine is allowed to enter the market after it completes three phases of clinical trials.

Bird flu remains essentially an animal disease, but experts fear that the H5N1 virus could mutate into a form that could pass easily among humans.

Worldwide, about a dozen companies are currently conducting clinical trials on bird flu vaccines.

According to the WHO, the H5N1 virus has proven difficult to predict, and as drug companies move forward with their pandemic vaccine development, they may be gambling on which virus they think is most likely to mutate into a killer strain.

The virus has killed 14 people in China since 2003 and 21 Chinese have contracted the virus.

The latest case was a 62-year-old man in Xinjiang Uygur Autonomous Region, who died on July 12. Enditem


Editor: Yangtze Yan

From all the news the most elaborated is the one from PRNewswire where the credit is given to "Xinhua-PRNewswire" as a common release.
From my very personnal understanding, the vaccine is for the china's govnt use but they look for financial support to help them built vax plant ... or something like that...

-Ming

[JJackson]

Re: Another vaccine sales pitch ?

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.

1.32 Billion / 20 Million = 66 years. I hope they have good looooooooong term preps.

[ruthbeme]

Re: Chinese vax - Another vaccine sales pitch ?

This artical was also printed in Peoples Daily.

Chinese human bird flu vaccine tests safe, effective
http://english.peopledaily.com.cn/20...29_297691.html