| Novartis Is Celebrating. Should We?
On November 24, 2009, Novartis officially opened its first,
large-scale vaccine manufacturing facility in the U.S. Located
in Holly Springs, North Carolina. The project is a collaborative
effort between Novartis and the U.S. Department of Health and
Human Services, which contributed $457M for the design, construction,
and licensing of the facility.
For its part in the deal, Novartis is required to provide two
commercial-scale lots of "pre-pandemic" vaccine annually
for a minimum of three years. In addition, the government has
the right to exercise options to purchase influenza vaccine over
the next 17 years. (1) Currently, 191 employees work at the plant
but that will increase to 350 persons when fully operational,
anticipated to be sometime in 2011. The Holly Springs facility
will be able to roll out 150 million flu shots per year.
Even though its use has not been approved by U.S. regulators,
the plant will be producing MF59 as early as December 2009.(2)
MF59 is Novartis’ proprietary and controversial adjuvant
composed of squalene and a surfactant called Tween80, also known
as polysorbate 80. Back in July, 2009, the department of HHS purchased
over $343.8M of "oil-in-water" adjuvant from Norvartis.(3)
It looks like the government may want to take delivery on its
purchase some time soon.
All flu shots used in the U.S. are made from eggs, a time- and
labor-intensive process. But the new plant will provide something
different. Vaccines will be brewed from animal cells mixed with
viruses in six 1,320 gallon fermenters which are owned by the
U.S. government and the Department of HHS, as identified by a
bright yellow, plastic plaque on the sides of the giant vats.
(4)
The use of human and animal cells for biological and pharmaceutical
research is big business, particularly in Europe. For example,
the European Collection of Cell Cultures (ECACC), established
in 1984, is an international depository of cell culture collections.
The ECACC describes itself as having one of the "premier
collections of authenticated cell cultures in the world."
It holds more than 40,000 cell lines representing 45 different
species and 50 different tissue types. (5) Many of these lines
are used in cancer research; some are specifically made for use
with vaccines.
To replicate, influenza viruses need to be mixed with living
cells and several types of mammalian cells have been used for
this purpose since the 1950s. Examples include calf lymph for
smallpox vaccines, African green monkey cells (AGMK cells and
VERO cells) for polio vaccines, and mouse brain cells for Japanese
encephalitis vaccines. In the 1960s, tissues from aborted human
fetal tissue, called MRC-5 and WI-38 cells, were developed and
are still used for the manufacture of rubella, hepatitis A, chickenpox,
and shingles vaccines. Since 2000, new cells under investigation
for making flu shots include cells derived from retinas of aborted
fetuses (PER.C6), cells from ovaries of Chinese hamsters, and
even cells from insects.
Perhaps even the FDA agrees that a vaccine made from infected
caterpillar eggs is just a little too weird. On November 19, an
FDA panel voted 6 to 11 against the approval of FluBlok, flu shots
made from bugs, citing "lack of safety data" as the
reason. Made by Protein Sciences Corp. of Meriden, Connecticut,
FluBlok would have been the first cell-line influenza vaccine
licensed in the U.S. (6) Novartis must have been thrilled that
its closest U.S. cell-line competitor was knocked out of the running
days before it officially announced the launch of its Holly Springs
plant.
Novartis still needs approval of its cell line, MDCK cells originating
from dog kidneys, before it can ramp up flu shot production. Novartis
has been using MDCK cells for several years to make its European-approved
influenza vaccines: Optaflu, for seasonal flu, and Celtura, for
swine flu. I find it interesting that the plant has been built,
the vats are in place and the opening ceremony has been announced…and
yet, flu shots made from dog cells have not been approved by U.S.
regulators.
Concerns about Injected Animal Cells
When viruses are combined with animal and human cells in culture,
the new, "immortalized" cells can replicate in perpetuity.
By their very design, the cells are neoplastic (i.e. abnormal).
If these abnormal clumps cause tumors when injected into experimental
animals, the cell line is called tumorigenic. If the tumors are
cancerous, the cell line is labeled as oncogenic. (7)
No matter how careful manufacturers try to be, animal cells,
animal DNA and culture-contaminating viruses end up in the final
vials. While dog kidney cells have reportedly fewer stray viral
contaminants than eggs, the injection of animal DNA could have
untoward results in humans. The FDA is aware of this and is rightfully
concerned. These stray proteins can be incorporated into vaccine
recipient’s own DNA, leading to the risk of abnormal genetic
transcription. To minimize that possibility, the FDA has set manufacturing
guidelines: The final vaccine product should have less than 1
million residual [animal] cells and less than 10 ng of DNA. (8)
The FDA trusts that vaccine manufacturers will comply with these
standards. I wonder who will be responsible for quality control
and batch checking?
I find it disturbing that the FDA has been discussing cell-line
concerns since 1998. Couldn’t manufacturers develop something
better? Less risky? Less disgusting? An even bigger question is,
knowing the potential cancer-causing risks of animal cell lines,
why have government regulators allowed this technology to evolve
and be used at all?
Concerns about the adjuvant, MF59
An adjuvant is molecule added to a vaccine so that less antigen
(virus) is needed to achieve an antibody response. This reduces
vaccine production costs and when the amount of virus is in short
supply, adding an adjuvant stretches the available vaccine supply.
With a few exceptions, adjuvants are foreign to the body and can
cause adverse reactions.
Several types of adjuvants are used today. The most common are
aluminum hydroxide, aluminum phosphate and calcium phosphate.
There are a number of others under investigation: oil-based emulsions,
products from bacteria, liposomes, endotoxins, and aliphatic amines.
(9) Of these, oil-in-water adjuvants are at the forefront because
they have been added to several of the pandemic swine flu vaccines.
Scientific data in peer-reviewed journals show that ingested
squalene, available as shark liver oil in health food stores,
passes easily through the digestive tract. It is a very different
story when squalene is injected into the arm. Pearson and his
associates at UCLA injected dozens of oils, including squalene,
into rats and found that all the oils were toxic, inducing arthritis
with varying degrees of severity. Based on their ability to cause
join pain, the oils were assigned "arthritis scores,"
ranging from (+), considered to be mildly toxic, to (++++), which
was "guaranteed to cripple." Squalene was given a score
of (+++). In addition, all rats injected with squalene developed
symptoms that, in humans, would look very much like Guillain-Barre
syndrome: the animals were crippled and paralyzed, dragging their
hindquarters across their cages. (10)
Squalene stimulates an excessive and nonspecific immune response.
A study using electron microscopy was undertaken to examine neurological
tissue of mice after they had been given 20g/kg of squalene for
four days. The devastating effects squalene were seen in both
the central and peripheral nervous system. Researchers documented
swollen astrocytes (brain cells) and disintegration of myelin
sheath throughout the brain. Peripherally, the myelin sheaths
were destroyed and the nerves were compressed. It was concluded
that squalene "produces characteristic pathological changes
in both the central and peripheral nervous systems. (11)
Granted, this is a very large dose of squalene. However, even
a trace amount is not harmless. In immunology, parts-per-billion
is a substantial dose. A mere 10 ppb concentration of squalene
translates into approximately 184 trillion molecules of squalene
and an equal number of potentially destructive immune responses.
(12) More than two dozen peer-reviewed scientific papers from
ten different laboratories throughout the U.S., Europe, Asia,
and Australia have published studies documenting autoimmune disease
in animals injected with squalene-based adjuvants.
A convincing proposal for how this occurs can be explained through
the concept of "molecular mimicry." Squalene is a normally
occurring molecule within the body. It is a precursor of cholesterol
and it is on the surface of most cells, particularly throughout
the nervous system. The squalene droplets from the vaccine are
transported by immune cells to the lymphatic system where antibodies
against them are formed. Later, the squalene antibodies can cross
react with squalene found normally throughout the body, leading
to debilitating autoimmune and nervous system diseases.
MF59 – like similar oil-in-water adjuvants – is capable
of an accelerated activation of the immune system. Once "turned
on," there is no switch to turn it off. The results of long-term
reactions are unknown and most likely will remain unknown. Following
patients for an extended period to look for the development of
serious reactions is not what the vaccine industry is interested
in studying.
Despite substantial evidence–and even admissions of concern–the
FDA and the government are moving forward with its celebrated
relationship with Novartis. If there is any doubt, there should
be no doubt. These concerns, and others outside the scope of this
article, deserve an in depth investigation prior to proceeding.
Let the buyer – and the vaccine recipient – beware.
Full
article including references.
Reference Source: infowars.com
December 10, 2009
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