Fast-tracked Swine Flu Vaccine under Fire

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http://www.i-sis.org.uk/fastTrackSwineFluVaccineUnderFire.php

ISIS Report 27/07/09

Fast-tracked Swine Flu Vaccine under Fire

The vaccines far more deadly than the swine flu; mass vaccinations a

recipe for disaster Dr. Mae-Wan Ho and Prof. Joe Cummins

 

This report has been submitted to Sir Liam Donaldson, Chief Medical

Officer of the UK, and to the US Food and Drugs Administration

 

Please forward widely to your government representatives, wherever you are

A swine flu 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 [1, 2], judging from the first data

released in May. It is a messy combination of sequences from bird,

human and swine flu 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 [3]. Some even suggest it was made intentionally

as a bioweapon [4], 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 [5]. But what worries the public most is the mass

vaccination programmes 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 countrys vaccine watchdog National

Vaccine Information Center (NVIC) has called on the Obama

Administration and all state Governors to provide evidence that the

move is [6] necessary and safe, demanding strong mechanisms for

vaccine safety screening, recording, monitoring, reporting and

vaccine injury compensation.

 

The US Departments of Health and Homeland Security had declared a

national public health emergency in April soon after the swine flu

outbreak. As a result, some schools were closed, people quarantined,

and drug companies were given contracts worth $7billon to make

vaccines that are being fast tracked by the Food and Drugs

Administration [7]. 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 swine flu

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

manufacturers name and lot number;

 

3. Recording which vaccines were given in the childs medical record;

and 4. Recording serious health problems that develop after

vaccination in the childs 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 swine flu vaccines,

whether parents will be given complete, truthful information about

swine flu vaccine risks, and have the right to say no to vaccination.

 

Co-founder and president of NVIC Barbara Loe Fisher said [6]: Parents

and legislators should be asking themselves right now: Why are

children the first to get experimental swine flu 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) [8]. 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.

 

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 dont work

and are dangerous [9].

 

Flu shots ineffective and increase risks of asthma

There are widely acknowledged reasons why flu vaccines wont work, as

already pointed out with regard to the much touted vaccines against

the pandemic bird flu that has yet to materialize [10] (How to Stop

Bird Flu Instead, SiS 35). 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 wont 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 swine flu 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 [11]. A report published in 2008 found

flu vaccines in young children made no difference in the number of

flu-related doctor and hospital visits [12].

 

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 [13]; 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 [14]

 

Flu vaccines are equally useless for adults, including the elderly,

giving little or no protection against infection or illnesses

including pneumonia (see [9]).

 

Toxic adjuvants in flu vaccines

Vaccines themselves can be dangerous, especially live, attenuated

viral vaccines or the new recombinant nucleic acid vaccines [10],

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 [9]. 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 [15]. Numerous new adjuvants

are no better, and could be worse. According to a recent review in a

science and business pharmaceutical publication [15], most newer

adjuvants including MF59, ISCOMS, QS21, AS02, and AS04 have

substantially higher local reactogenicity and systemic toxicity than alum.

 

Current status of swine flu vaccines

Five different companies have been contracted to produce vaccines

worldwide: Baxter International, GlaxoSmithKline, Novartis and

Sanofi-Aventis and AstroZeneca [16]. Already stretched beyond

capacity, there is every intention to make smaller vaccine doses go

further with a range of new adjuvants [17], with the blessing of the

WHO (see later).

 

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 viruss surface proteins,

haemagglutinin (H) and neuraminidase (N), which determine the strains

virulence and ability to spread, and are also the target proteins for

vaccine production.

 

Influenza viruses

There are 3 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 8 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) [18]. 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 [19].

 

 

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 [20].

 

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 [21]. 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 [22, 23]. The main finding was that

the toxic adjuvant did not increase neutralising 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 [16].

 

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 [24]. 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 swine flu vaccine using cell-based technology and the

proprietary adjuvant MF59.. The MF59. adjuvant is oil based and

contains Tween80, Span85, and squalene [25]. In studies of oil-based

adjuvants 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 [26].

 

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 [27, 28]. Novartis claimed

the deaths were unrelated to the H5N1 vaccine [29], which had been

tested on 3500 other people without any deaths.

 

GlaxoSmithKlines 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 [30], AS03 adjuvant is composed of squalene (10.68

milligrams), DL-?-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 [31].

 

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 adjuvants) 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, Mr 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 [32].

 

The last mass-vaccination in the US was a disaster. In 1976, cases of

swine flu were found in soldiers at Fort Dix, New Jersey, and one of

them died, most likely of physical overexertion rather than from the

infection [7]. 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 [33, 34].

 

Swine flu 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 fatalites/case ratio of 0.8 percent

[35]; 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 [36].

 

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 tamiflu 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 [37], giving a fatalities/case

ratio of 0.03 percent, a more accurate reflection of the actual death rate.

 

UKs 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 [38].

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 [39] 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 isnt properly calibrated, and

could lead to shots that dont protect people from the virus or at

worse are unsafe, Pennington said.

 

Pennington added that the shots ability to trigger the bodys defences

is crucial and requires tests to determine the best dose and whether

an adjuvant is needed to bolster the immunity. (As we know, GSK is

definitely promoting its new range of toxic adjuvants.) He also

referred to the Fort Dix incident in 1976 (see earlier).

 

France has ordered vaccines from Sanofi, GSK and Novartis, but sees

no reason to ask vaccine makers to shorten or skip clinical trials

[16]. Sanofi-Aventis, the French drug maker developing its own swine

flu vaccine will begin testing the product in early August, and

estimates it will need as much as two and a half months of tests

before having a shot thats both safe and protective, according to

Albert Garcia, speaking for the companys vaccine unit, the vaccine

will be ready in November or December, he said.

 

Baxter, however, will produce a vaccine by early August for clinical tests.

 

Glaxo also said it is developing a face mask coated with antivirals

to prevent infection and boosting production of its Relenza drug for

patients already suffering from swine flu.

 

There are obviously safer and more effective ways to combat the

pandemic than mass vaccinations: washing hands often, sneezing into a

tissue that can be safely disposed of, avoiding unnecessary

gatherings, and delay opening schools - all advised by governments -

and we would add, eating healthily, exercise, and getting enough

vitamin D to boost your natural immunity [10].

 

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