Fast-tracked H1N1 influenza vaccine under fire

Dr. Mae-Wan Ho and Prof. Joe Cummins

The vaccines are far more deadly than the swine flu; mass vaccination is not the answer to addressing the problem

AH1N1 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 H1N1 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 program 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 US Departments of Health and Homeland Security had declared a national public health emergency in April soon after the H1N1 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 H1N1 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 H1N1 vaccines, whether parents will be given “complete, truthful information about H1N1 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 H1N1 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.

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 H1N1 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.

Toxic adjuvant 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.”

Current status of H1N1 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 adjuvants, 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.

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 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.

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.

Novartis, another big pharma, announced on 13 June that it, too, has produced a H1N1 vaccine using cell-based technology and the proprietary adjuvant MF59®. The MF59® adjuvant is oil based and contains Tween80, Span85, and squalene. 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.

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 dead; 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 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, 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.

- Third World - Network Features

(The writers: 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.)

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).

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.

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.