- 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,
- 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
- 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
- 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
- "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;
- 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
- "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 Daily.com, 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
- "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
- Zhan le Devlesa tai sastimasa
- Go with God and in Good Health