Fast tracked A H1N1 influenza virus under fire
ANovel Influenza outbreak occurred in Mexico and the United States in
April 2009 and spread rapidly around the world by human-to-human
transmission. The new type A H1N1 influenza virus is unlike any that had
been previously isolated, judging from the first data released in May.
It is a messy combination of sequences from bird, human and Novel
Influenza virus lineages from North America and Eurasia.
A senior virologist based in Canberra, Australia, told the press he
thought that the virus could have been created in the laboratory and
released by accident. Some even suggest it was made intentionally as a
bioweapon, while others blame the intensive livestock industry and
extensive trafficking of love animals over long distances, which provide
plenty of opportunity for generating exotic recombinants. But what
worries the public most is the mass vaccination programs
Novartis was in
the news in 2008 for a clinical trial of a H5N1 vaccine in
Poland. The trial was administered by local nurses and doctors
who gave the vaccine to 350 homeless people, leaving 21 died;
and were prosecuted by the Polish police. Novartis claimed the
deaths were unrelated to the H5N1 vaccine, which had been
“tested on 3500 other people without any deaths.” |
Governments are putting in place to combat the emerging pandemic,
which could well be worse than the pandemic itself.
Watchdog opposes fast-track vaccine for school children
The US Government is intending to vaccinate all children in September
when school re-opens, and the country’s vaccine watchdog National
Vaccine Information Center (NVIC) has called on the Obama Administration
and all state Governors to provide evidence that the move is “necessary
and safe”, demanding “strong mechanisms for vaccine safety screening,
recording, monitoring, reporting and vaccine injury compensation.”
The vaccines are far more deadly than the Novel Influenza; mass
vaccination is not the answer to addressing the problem. |
The US Departments of Health and Homeland Security had declared a
national public health emergency in April soon after the Novel Influenza
outbreak. As a result, some schools were closed, people quarantined, and
drug companies were given contracts worth US$7 billon to make vaccines
that are being fast tracked by the Food and Drugs Administration. That
means they will only be tested for a few weeks on several hundred
children and adult volunteers before being given to all school children
this fall.
Furthermore, under federal legislation passed by Congress since 2001,
an Emergency Use Authorization allows drug companies, health officials
and anyone administering experimental vaccines to Americans during a
declared public health emergency to be protected from liability if
people get injured. US Secretary of Health and Human Services Kathleen
Sebelius has granted vaccine makers total legal immunity from any
lawsuits that may result from any new Novel Influenza vaccine. And some
states may make the vaccination mandatory by law.
The NVIC is asking whether the states are prepared to obey vaccine
safety provisions in the 1986 National Childhood Vaccine Injury Act,
which include, 1. Giving parents written information about vaccine
benefits and risks before children are vaccinated, 2. Keeping a record
of which vaccines the children get, including the manufacturer’s name
and lot number, 3. Recording which vaccines were given in the child’s
medical record, and 4. Recording serious health problems that develop
after vaccination in the child’s medical record and immediately making a
report to the federal Vaccine Adverse Event Reporting System.
NVIC also wants to know if the states are prepared to provide
financial compensation to children injured by the Novel Influenza
vaccines, whether parents will be given “complete, truthful information
about Novel Influenza vaccine risks”, and have the right to say “no” to
vaccination.
Co-founder and president of NVIC Barbara Loe Fisher said, “Parents
and legislators should be asking themselves right now, why are children
the first to get experimental Novel Influenza vaccines? Are schools
equipped to get signed informed consent from parents before vaccination,
keep accurate vaccination records and screen out children biologically
at high risk for suffering vaccine reactions? Will people giving these
vaccines know how to monitor children afterwards and immediately record,
report and treat serious health problems that develop? And will states
have the financial resources to compensate children who are injured?”
WHO and mass vaccination fever
The mass vaccination order has come from the World Health
Organization (WHO). In early July 2009, a group of vaccination experts
concluded that the pandemic is unstoppable, and Marie-Paul Kieny, WHO
director on vaccine research said all nations will need access to
vaccines, and that a vaccine should be available as early as September.
Pigs being tested for the Novel Influenza |
Critics point out that the ‘vaccination experts’ are dominated by the
vaccine makers standing to gain from the enormously lucrative vaccine
and antiviral contracts awarded by Governments. But the decisive
argument against mass vaccinations is that flu shots simply don’t work
and are dangerous.
Flu shots ineffective and increase risks of asthma
There are widely acknowledged reasons why flu vaccines won’t work, as
already pointed out with regard to the much touted vaccines against the
‘pandemic bird flu’ that has yet to materialize. The flu virus changes
quickly - even without the help of genetic engineering in the
laboratory, and especially with the help of the intensive livestock
industry - whereas the vaccines target specific strains. Furthermore,
flu vaccination does not give permanent protection, and must be repeated
annually; the vaccines are difficult to mass-produce, and some strains
won’t grow at all under laboratory conditions.
Numerous studies have documented that flu shots give little or no
protection against infection and illness, and there is no reason to
believe that Novel Influenza vaccines will be different.
A review of 51 separate studies in 2006 concluded that flu vaccines
worked no better than a placebo in 260 000 children ranging in age from
six months to 23 months. A report published in 2008 found flu vaccines
in young children made no difference in the number of flu-related doctor
and hospital visits.
On the other hand, a study of 800 children with asthma found that
those receiving a flu vaccine had a significantly increased risk of
asthma-related doctor and emergency room visits; the odds ratios were
3.4 and 1.9 respectively. This was confirmed in a report published in
2009, which showed children with asthma who received FluMist had a
3-fold increased risk of hospitalization.
Flu vaccines are equally useless for adults, including the elderly,
giving little or no protection against infection or illnesses including
pneumonia.
Influenza viruses
|
There are
three types of influenza viruses, A, B and C. The influenza A
type virus is the main one that cause diseases in birds and
mammals. Its genome consists of eight segments of RNA coding for
11 proteins, and the viruses are further classified by subtype
on the basis of the two main surface glycoproteins (proteins
with complex carbohydrate side chains): haemagglutinin (H) and
neuraminidase (N). The segmented genome enables the virus to’
reassort’ (shuffle) segments as well as recombine within
segments, thereby greatly increasing the rate of evolution and
generation of new strains. Reassortment is also widely exploited
in the laboratory in the process of creating vaccine strains.
To-date, 16 H and 9 N subtypes have been detected in numerous
combinations circulating in wild birds. |
Toxic adjuvants in flu vaccines
Vaccines themselves can be dangerous, especially live, attenuated
viral vaccines or the new recombinant nucleic acid vaccines, they have
the potential to generate virulent viruses by recombination and the
recombinant nucleic acids could cause autoimmune diseases.
A further major source of toxicity in the case of the flu vaccines
are the adjuvants, substances added in order to boost the immunogenicity
of the vaccines. There is a large literature on the toxicities of
adjuvants. Most flu vaccines contain dangerous levels of mercury in the
form of thimerosal, a deadly preservative 50 times more toxic than
mercury itself.
At high enough doses, it can cause long-term immune, sensory,
neurological, motor, and behavioural dysfunctions. Also associated with
mercury poisoning are autism, attention deficit disorder, multiple
sclerosis, and speech and language deficiencies. The Institute of
Medicine has warned that infants, children, and pregnant women should
not be injected with thimerosal, yet the majority of flu shots contain
25 micrograms of it.
Another common adjuvant is alum or aluminium hydroxide, which can
cause vaccine allergy, anaphylaxis, and macrophage myofascitis, a
chronic inflammation syndrome, In cats, alum also gives rise to
fibrosarcomas at the site of injection. Numerous new adjuvants are no
better, and could be worse. According to a recent review in a science
and business pharmaceutical publication, most newer adjuvants including
MF59, ISCOMS, QS21, AS02, and AS04 have “substantially higher local
reactogenicity and systemic toxicity than alum.” - Third World Network
Features
(This report has been submitted to Sir Liam Donaldson, Chief Medical
Officer of the UK, and to the US Food and Drugs Administration.) Mae-Wan
Ho is the Director of the Institute of Science in Society (ISIS) in the
UK. Prof. Joe Cummins is Professor Emeritus of Genetics at the
University of Western Ontario in Canada.
Current status of Novel Influenza vaccines
Five different companies have been contracted to produce vaccines
worldwide: Baxter International, GlaxoSmithKline, Novartis and
Sanofi-Aventis and AstroZeneca. Already stretched beyond capacity, there
is every intention to make smaller vaccine doses go further with a range
of new adjuvant, with the blessing of the WHO.
Flu vaccines are traditionally produced from non-virulent (attenuated
or weakened) influenza viruses (see Box for a description of the
viruses). To be effective, the genes of the non- virulent virus used
must match those of the viral strain spreading in the population.
Activation of the immune system by exposure to the non pathogenic
form of the circulating pathogenic strain leads to the production of
antibodies that will confer protection against the pathogenic strain.
Producing the non-virulent virus involves first identifying and then
recreating the subtypes of two of the virus’s surface proteins,
haemagglutinin (H) and neuraminidase (N), which determine the strain’s
virulence and ability to spread, and are also the target proteins for
vaccine production.
United States Food and Drug Administration
Seed viruses are first made to provide the starting material for
large scale production of live non-virulent flu viruses. The seed
viruses are approved by the WHO or the United States Food and Drug
Administration (USFDA). The usual method of seed virus production is
reassortment (see Box). Fertilized chicken eggs are injected with both a
standard non-pathogenic influenza strain known to grow well in eggs and
the strain that carries the genes expressing the desired vaccine H and N
protein subtypes.
The two viruses multiply, and their eight genome segments reassort
with 256 possible combinations.
The resulting recombinant viruses are then screened for the desired
virus with the six genome segments that allow the standard strain to
grow so well in eggs and the H and N genes from the circulating strain.
The seed virus is then injected into millions of eggs for mass
production of vaccine. This conventional method of seed stock production
takes about one to two months to complete.
Cell culture systems may eventually replace chicken eggs. Baxter
International applied for a patent on a process using cell culture to
produce quantities of infecting virus, which are harvested, inactivated
with formaldehyde and ultraviolet light, and then detergent. Baxter has
produced H5N1 whole virus vaccines in a Vero cell line derived from the
kidney of an African green monkey, and conducted phase 1 and 2 clinical
trials with and without aluminium hydroxide as adjuvant. The main
finding was that the toxic adjuvant did not increase neutralizing
antibodies against the vaccine strain. Baxter has agreed to ship H1N1
vaccine by the end of July or early August 2009 but details of the
production of that vaccine have not yet been released to the public.
In December, a Baxter facility in Austria sent a human flu vaccine
contaminated with the deadly H5N1 live avian flu virus to 18 countries,
including the Czech Republic, where testing showed it killed the ferrets
inoculated. Czech newspapers questioned whether Baxter was involved in a
deliberate attempt to start a pandemic.
Norvatis, another big pharma, announced on 13 June that it, too, has
produced a Novel Influenza vaccine using cell-based technology and the
proprietary adjuvant MF59(r). The MF59(r) adjuvant is oil based and
contains Tween80, Span85, and squalene.
In studies of oil-based adjuvant in rats, the animals were rendered
crippled and paralyzed. Squalene brought on severe arthritis symptoms in
rats, and studies in humans given from 10 to 20 ppb (parts per billion)
of squalene showed severe immune system impact and development of
autoimmune disorders.
Novartis was in the news in 2008 for a clinical trial of a H5N1
vaccine in Poland. The trial was administered by local nurses and
doctors who gave the vaccine to 350 homeless people, leaving 21 died;
and were prosecuted by the Polish police. Novartis claimed the deaths
were unrelated to the H5N1 vaccine, which had been “tested on 3500 other
people without any deaths.”
GlaxoSmithKline’s vaccine will be made up of antigens of the recently
isolated influenza strain, and also contains its own proprietary
adjuvant system AS03 that has been approved in the EU along with its
H5N1 bird flu vaccine in 2008. According to the European Public
Assessment Report, AS03 adjuvant is composed of squalene (10.68
milligrams), DL-a-tocopherol (11.86 milligrams) and polysorbate 80 (4.85
milligrams).
The H5N1 vaccine also contains 5 micrograms thiomersal, as well as
Polysorbate 80, Octoxynol 10, and various inorganic salts. The company
is aggressively promoting various adjuvant systems as its ‘adjuvant
advantage’ that reduces the dose of vaccines.
A recent WHO survey of primary vaccine producers concluded that the
potential output of 4.9 Billion doses of H1N1 vaccine per year is a
best-case scenario, assuming among other factors that the most
dose-sparing formulation (that will include toxic adjuvant) be selected
by each manufacturer and that production will take place at full
capacity.
WHO Director-General, Dr .Margaret Chan, and the United Nations
Secretary-General, Ban Ki-moon, met with senior officials of vaccine
manufacturers on 19 May and asked them to reserve part of their
production capacity for poor countries that would otherwise have no or
little access to vaccine in the case of a pandemic.
The last mass-vaccination in the US was a disaster. In 1976, cases of
Novel Influenza were found in soldiers at Fort Dix, New Jersey, and one
of them died, most likely of physical overexertion rather than from the
infection. This led to the launch of a mass vaccination of 40 million
against a pandemic that never materialized. Thousands filed claims for
injury. At least 25 died and 500 developed paralyzing Guillain-Barre
syndrome.
Novel Influenza syndromes mostly mild
As of 22 July 2009, the CDC listed a total of 40, 617 cases in the
US, with 319 fatalities, giving a fatalities/case ratio of 0.8 percent;
though the real death rate, among all cases of infection including the
mild ones that go unreported, is probably much lower. Experts estimate
that only 1 out of 20 cases are reported.
The UK is the worst affected European country, and the pandemic is in
the headlines everyday in July. A new telephone helpline was set up on
23 July to let people get advice and Tami flu without seeing a doctor.
In that week, there has been a record rise in cases to 100 000 and a
total of 30 deaths so far, giving a fatalities/case ratio of 0.03
percent, a more accurate reflection of the actual death rate.
UK’s chief medical officer Sir Liam Donaldson has ordered the NHS to
plan for as many as 65 000 deaths, with 350 a day at the peak. There has
been no plan as yet for mass vaccination; but the UK government has
advance orders for 195 million doses of vaccine with GlaxoSmithKline (GSK).
The vaccine that GSK is developing will be tested on a limited number
of people as the UK drug company reportedly ‘weighs the pandemic danger
against the risks of an unsafe shot’. This was criticized as ‘risky’ by
Prof. Hugh Pennington, a retired microbiologist at the University of
Aberdeen, Scotland.
“By limiting clinical trials, Glaxo raises the danger that the
vaccine dose isn’t properly calibrated, and could lead to shots that
don’t protect people from the virus or at worse are unsafe,” Pennington
said.
Third World Network Features
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