Nine Arrested Selling
Fake Bird Flu Vaccine
From Patricia Doyle, PhD
Hello, Jeff - This is just the type of reckless behavior that we do not need. The vaccine is suspected of contributing to an outbreak of the disease in northeastern China's Liaoning Province.
Just the act of attempting to vaccinate 5.2 BILLION farm raised birds is a difficult task. This task is being made more difficult by bogus vaccines sold by unscrupulous individuals with only one motive, profit.
It is imperative to contain bird flu while in the animal populations. As we have been reporting, there have been limited human cases of H5N1, and those, for the most part, were due to contact with sick birds.
As H5N1 widens in the avian community, there is always a chance that it might recombine with a human influenza. And then we would have a very serious problem...
Patricia Doyle
From ProMED-mail
China Daily/AFP
9 people have been arrested for selling fake bird flu vaccines that are suspected to have contributed to an outbreak of the disease in northeastern China's Liaoning province.
Police have arrested officials of the Jinyu Group, a company based in Inner Mongolia that produces medicines, and of the Inner Mongolian Biological Medical Products Factory, the Liaoxi Commercial Daily reported Wednesday [30 Nov 2005].
After a 20-day investigation covering 4 provinces and regions, police found the 2 companies had manufactured and sold 200 000 vials of 12 different kinds of bird flu vaccine nationwide, the report said.
With 29 outbreaks of the disease discovered so far this year, China is seeking to vaccinate its estimated 5.2 billion farm-raised birds, but requires manufacturers to have a license to produce the vaccines.
Police said that the Jinyu Corporation failed to apply for a license from the state to manufacture bird flu vaccines for poultry, but labelled its products with fake government licensing numbers, it said.
Investigators found the fake vaccines were used on farms in Liaoning's Jinzhou region, where an outbreak of bird flu occurred in mid-October 2005, the report said.
Some 2.5 million farm raised birds were culled in the Jinzhou region following the outbreak, devastating the livelihood of farmers in the region.
The relationship between the 2 suspected companies was not immediately clear, but one man arrested, Wang Jiafu, was a vice director of the Jinyu Corporation as well as the legal representative of the Inner Mongolian Biological Medical Products Factory, [the report] said.
The government warned this month that the use of fake vaccines in Liaoning could have disastrous consequences for China. "The use of fake and shoddy vaccines will result in a disaster," Agriculture Minister Du Qingling said on 9 Nov 2005. "If the vaccines are not up to standard, then immunization to the virus will not be uniform or effective. This could bring huge losses."
Farms in Liaoning were highly concentrated, Du said, meaning that any problems in vaccinating poultry could result in the epidemic spreading.
"If we miss the chance to exterminate the virus in the early stages, then the difficulty in wiping it out will increase by several times, as will the spread of the epidemic," Du said. "We must fully recognize that at present there is a possibility that the epidemic will spread and expand. This is not an exaggeration just to scare people."
Hopefully, the current efforts to tackle illegal vaccines for poultry (and other animals?!) in China will be more effective than in the past. The practice, apparently related to the higher prices (and more laborious application mode?) of licensed vaccines, has been ongoing for an extended period. It seems to be widespread, involving numerous unlicensed manufacturers in various provinces; see "Crack down on fake poultry vaccines; all provinces instructed to deal with the problem" in posting 20040211.0462, 11 Feb 2004.
In a previous posting, we presented the names of the 9 laboratories licensed in China to produce avian influenza vaccines. The control upon vaccine production in China was one of the issues addressed during a visit by OIE experts to China in May 2004. Their report included the following information:
"Evaluation of the avian influenza vaccine (inactivated) manufacturing and controls
Institute of Veterinary Drug Control: Initially outlines of production were presented, as well as general data concerning the method of preparation of the finished products (H5N2 and H9). Subsequently a more complete presentation was made that discussed the quality controls for in-process products and finished products. The subsequent presentation summarised the measures taken to ensure the quality of inactivated AI vaccines produced in China, i.e. product license system, audit system by IVDC inspectors in manufacturing plants, and tests on each batch produced. The IVDC approval for batch release is granted when satisfactory test results by the manufacturer are received. In this case, the Manufacturer's Release Certificate is countersigned and stamped by the IVDC and returned to the sender accompanied by a number of "Approbation labels" equivalent to the number of vaccine bottles filled with the batch volume. Satisfactory batches are identified by additional government labels stuck on the vaccine bottle cap, with the aim to prevent sales of fake vaccines." - Mod.AS
From: ProMED-mail
Source: China's Central TV (CCTV), 26 Nov 2005 [translated; edited]
The following summary has been extracted, by a reliable Chinese contact, from a TV interview covering the activities of the Veterinary Research Institute of the Chinese Academy of Agricultural Sciences, Harbin (HVRI):
"The inactivated H5N1 vaccine used in China was produced from a recombinant strain of LPAI (H5N1) constructed by reverse-genetic techniques. The HA and NA were taken from a local prevalent dominant strain of H5N1(the sites related to the high pathogenicity in HA was blocked/deleted), and the other 6 genes were taken from the PR8 strain (previously isolated from humans). This recombinant can grow well in Vero cells and chicken embryo. The use of this recombinant as a vaccine candidate has been subject to extensive debates among Chinese scientists; a lot of concern was [expressed regarding] the potential for a 'gene switch' for the vaccine strain and field HPAI viruses and regarding bio-safety procedures."
Our Chinese contact adds: detailed information on the vaccine would have allowed a serious look at relevant potential risks. However, the vaccine has been widely used nationwide and the outcome is not known. In the meantime, another new vaccine, bivalent Avian influenza/Newcastle disease vaccine, has been developed and quickly put into production before thorough bio-safety studies. Hopefully, the political pressures for an immediate solution -- namely releasing prematurely the experimental vaccines for extensive field application -- won't [hinder] the scientists' pursuit for truth and perfection.
In view of the above remark, we have decided to include the following relevant newswire which was forwarded to us by Mark Schipp on 16 Oct 2005 but not posted at that time. - Mod.AS
From ProMED-mail
Source: Reuters via China, 16 Oct 2005
China has developed a new and better vaccine for use on birds against the avian influenza strain that scientists fear could cause a global pandemic among humans, media reports said on Saturday.
The vaccine has the advantage of fighting another common bird disease, as well as the H5N1 influenza strain that has spread from Asia to Europe, state television reported. It identified this as avulavirus APMV-1, also known as Newcastle disease.
"What's more, the new vaccine is safer, more convenient to use and cannot kill newborn chicks," it said, listing attributes that made it more attractive to farmers than a vaccine they were already using. For example, the new vaccine could be applied by spraying.
"In addition, the cost of the new vaccine in mass production is only 1/5 that of the previous vaccine."
The country was preparing to put the vaccine into mass production, Xinhua new agency reported. The H5N1 bird flu strain emerged in Hong Kong in 1997, resurfaced in 2003 in South Korea, and has since spread to other Asian countries and Europe.
Posted by Mark Schipp
Agriculture Counsellor
Australian Embassy, Beijing
[The Chinese bivalent vaccine might be related to a previously published paper on experimental recombinant NCD/AI vaccine, namely - Swayne DE, Suarez DL, Schultz-Cherry S, Tumpey TM, King DJ, Nakaya T, Palese P, Garcia-Sastre A. (2003). Recombinant paramyxovirus type 1-avian influenza-H7 virus as a vaccine for protection of chickens against influenza and Newcastle. Avian Dis. 47(3 Suppl):1047-50.
For convenience, see the following abstract of the said paper:
"Current vaccines to prevent avian influenza rely upon labor-intensive parenteral injection. A more advantageous vaccine would be capable of administration by mass immunization methods such as spray or water vaccination. A recombinant vaccine (rNDV-AIV-H7) was constructed by using a lentogenic paramyxovirus type 1 vector (Newcastle disease virus [NDV] B1 strain) with insertion of the hemagglutinin (HA) gene from avian influenza virus (AIV) A/chicken/NY/13142-5/94 (H7N2). The recombinant virus had stable insertion and expression of the H7 AIV HA gene as evident by detection of HA expression via immunofluorescence in infected Vero cells. The rNDV-AIV-H7 replicated in 9-10 day embryonating chicken eggs and exhibited hemagglutinating activity from both NDV and AI proteins that was inhibited by antisera against both NDV and AIV H7.
Groups of 2-week-old white Leghorn chickens were vaccinated with transfectant NDV vector (tNDV), rNDV-AIV-H7, or sterile allantoic fluid and were challenged 2 weeks later with viscerotropic velogenic NDV (vvNDV) or highly pathogenic (HP) AIV. The sham-vaccinated birds were not protected from vvNDV or HP AIV challenge. The transfectant NDV vaccine provided 70 percent protection for NDV challenge but did not protect against AIV challenge. The rNDV-AIV-H7 vaccine provided partial protection (40 percent) from vvNDV and HP AIV challenge. The serologic response was examined in chickens that received 1 or 2 immunizations of the rNDV-AIV-H7 vaccine. Based on hemagglutination inhibition and enzyme-linked immunosorbent assay (ELISA) tests, chickens that received a vaccine boost seroconverted to AIV H7, but the serologic response was weak in birds that received only one vaccination. This demonstrates the potential for NDV for use as a vaccine vector in expressing AIV proteins".
Most likely, the Chinese scientists applied a similar approach, inserting an H5 gene (from which virus strain?) instead of H7.
It would be helpful to obtain data on their work, particularly the methods and results of challenge trials, hopefully with better results than the ones obtained by the experimental rNDV-AIV-H7 vaccine. - Mod.AS]
Patricia A. Doyle, DVM, PhD Business Administration -Tropical Ag. Economics
Please visit my "Emerging Diseases" message board at:
Zhan le Devlesa tai sastimasa
Go with God and in Good Health




This Site Served by TheHostPros