Swine Flu Pandemic - To Vaccinate or Not to Vaccinate?

The 2009 pandemic strain is milder than the seasonal flu; the most authoritative evidence on flu vaccines is that they are ineffective, and could have a range of adverse side-effects arising from production contaminants and adjuvants; the live attenuated vaccine intended as a nasal spray for children is genetically unstable and risk generating a more dangerous pandemic virus if mass vaccinations are to proceed. We have a swine flu pandemic, and the burning question for everyone, especially those with young children, is to vaccinate or not to vaccinate? So what is this pandemic swine flu? It is caused by a completely new H1N1 flu virus that has a combination of genes from bird, human and swine flu viruses from North America and Eurasia [1] that appeared suddenly out of nowhere (see Fig. 1).

The flu virus is very complicated. It is a RNA virus with 8 gene segments and different strains can exchange gene segments by a process called reassortment. This is also why flu virus can change much faster than other viruses with only one continuous genome. The history of reassortment events can be reconstructed by comparing the base sequences of different strains. The 2009 pandemic strain involves intermediate steps that are not so easy to go undetected, given that there is routine surveillance of flu strains and quarantine on live animals moving between countries, let alone continents.

Some people are convinced the virus has been created in the lab as a conspiracy to depopulate the planet. Some blame the intensive livestock industry [3], which indeed could have contributed. The most plausible theory so far, is perhaps one due to virologist Adrian Gibbs, that it came from a faulty ‘multivalent’ vaccine containing several viruses created in the lab and given to pigs in America [4] (Swine Flu Virus Created from Pig Vaccine? SiS 44)..

Swine flu pandemic so far

The virus thus created has spread rapidly by human to human contact after the initial outbreak in Mexico around March or earlier in 2009 [5]. The World Health Organization (WHO) declared a pandemic in June. As of 10 September 2009, there are 337 197 lab confirmed cases and 3 559 deaths, giving a case-mortality rate of 1.1 percent. Of course, this is much higher than the actual death rate of the viral infection, because most infections are very mild. The lab confirmed cases are those that require hospital treatment, and deaths occur mainly among persons that had underlying conditions such as asthma, diabetes, obesity, heart disease, or a weakened immune system. For comparison, WHO estimates (also quite unreliable) that annual seasonal flu infects 5 to 15 percent of the population, with death-rate <0.05 percent, resulting in 250 000-500 000 deaths worldwide.

So everyone acknowledges that this is a very mild strain, even compared to the seasonal flu; but since WHO declared the pandemic, there has been pandemonium [6] (Fast-tracked Swine Flu Vaccine under Fire, SiS 43).

Mass vaccination fever around the world

Governments started stockpiling vaccines and antiviral drugs; and mass vaccinations have been announced in the USA [6], Italy [7], UK [8], Australia [9], France [6], Germany [10], Sweden [11], and now China [12], where there has been a big surge in the number of cases since school reopened in September.

The UK set up a pandemic hotline at the end of April 2009, so people can get the antiviral drug Tamiflu without seeing a doctor for prescription; and in just over three months, 895 ‘suspected’ adverse side-effects were reported including two deaths [13]. Studies on Tamiflu prescribed to healthy school children as preventative measures recorded side-effects in over half of them: gastrointestinal effects include nausea, vomiting, diarrhoea, stomach pains; and neuropsychiatric effects of insomnia and nightmares [14].

Japan started prescribing Tamiflu in 2005 in the wake of the H5N1 bird flu scare. In 17 months, 18 teenagers that have taken the drug committed suicide [15] How to Stop Bird Flu Instead (SiS 35). Studies clearing the drug suffer from conflict of interest as some researchers took large sums of money from the Japanese distributor of the drug [16].

Status of swine flu vaccines

So what about vaccines? There are at least 6 big companies making swine flu vaccines worth many billions. Baxter International makes a formaldehyde inactivated virus vaccine grown in Green Monkey Vero cell lines [6]. GlaxoSmighKline’s vaccine contains viral antigens with adjuvant ASO3 that has thimerosal and squalene among other things [6]; Novartis has inactivated virus vaccine grown in Green Monkey Vero Cells, with an oil-based adjuvant MF59 containing squalene and other things [6]. Sanofi-Aventis’ vaccine consists of sterile preservative free suspension prepared from influenza viruses propagated in chicken eggs. The virus-containing fluids are harvested and inactivated with formaldehyde [17]. AstroZeneca ‘s  vaccine arm, Medimmune, makes a live attenuated virus vaccine using Madin-Darby canine kidney (MDCK) cell line, or egg, and delivered as a nasal spray [18] (Live Attenuated Swine Influenza Vaccine for Children Safety in Question, SiS 44). CSL based in Melbourne Australia is making a propiolactone inactivated virus vaccine grown in chicken egg, and contains thimerosal in a two dose procedure but is preservative free when used as a single dose [19] (CSL Pandemic Swine Flu Vaccine Safety in Question, SiS 44).

No evidence that flu vaccines are effective or safe

There is no evidence that flu vaccines are effective or safe. But these vaccines are fast-tracked [6]; that means they will not go through the proper testing channels. (In fact, that has been the case for all seasonal flu vaccines.) In addition, 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 it is feared that some states may make the vaccination mandatory by law.

The most authoritative major review of flu vaccines by epidemiologist Tom Jefferson concluded [20]: “Evidence from systematic reviews show that inactivated vaccines have little or no effect.. Most studies are of poor methodological quality…In children under 2 years, inactivated vaccines had the same field efficacy as placebo… And in healthy people under 65 vaccination did not affect hospital stay, time off work, or death from influenza and its complications.”

Notably, it also concluded that “Little comparative evidence exists on the safety of these vaccines.”

There is no credible evidence that the vaccines helped the over 65. Some serious side effects have been indicated, and excess mortality in the vaccinated elderly suspected, as pointed out by a commentator [21]. Influenza mortality and the influenza related hospitalization rates significantly increased for elderly Americans between 1980 and 2000, a phenomenon only partly explained by the aging population. This stands in stark contrast to annual mortality changes in persons less likely to be immunized. Excess pneumonia and influenza deaths for persons under age 65 dramatically decreased between 1975 and 1994, and childhood mortality rates due to all respiratory illnesses fell markedly in the 1990s. If flu shots are effective, and if more older Americans have been getting them - why have more older Americans been dying of the flu?

The live attenuated viral vaccine from AstraZeneca/ Medimmune applied as a nasal spray was tested by the company on 7852 children at at 249 sites in 26 countries [18], but only against the inactivated vaccine. The overall ‘attack rate’ of influenza from the vaccine strain was 5 percent in the group that received live vaccine, and 10 percent in the group that received inactivated vaccine. Even if this result is real - as the inactivated vaccine gives little or no protection - the protection rate of the live vaccine against attack is at best 50 percent.

Vaccine efficacy of 0 to 50 percent will be practically useless in preventing a pandemic even at 100 percent vaccination rate.

But the safety record is worrying. The live viral vaccine more than doubled severe adverse events in children less than two years compared with the inactivated vaccine: 6.1 percent versus 2.6 percent. For both groups of vaccinated children the rates of adverse events are within the range of the normal attack rates of seasonal flu [20].

It is important to note that the MedImmune study [18] explicitly excluded children with a history of hypersensitivity to any component of the live attenuated vaccine or the inactivated vaccine, also known immunosuppressive condition, medically diagnosed or treated wheezing within 42 days before enrolment, a history of severe asthma, body temperature higher than 37.8 C within 3 days before enrolment and the use of aspirin or salicylate-containing products within 30 days before enrolment. The conditions italicized are precisely those considered especially at risk from swine flu and identified as ‘priority groups’ for receiving the vaccine by the UK government, which intends to vaccinate the entire UK population starting in October [8].

There is already evidence that the inactivated flu vaccine tripled the risk of severe events in children with asthma [22]. In the Medimmune study, wheezing within 42 days after the administration of dose 1 was more common with live attenuated vaccine, primarily among children 6 to 11 months of age, which had 12 more episodes of severe wheezing (3.8 percent, compared with 2.1 percent, p=0.076).

And we should not forget that a 1976 mass vaccination of 40 million in the USA left 25 dead, 500 with paralyzing Guillain-Barre syndrome, and thousands filing claims for injury [23, 24].

What’s wrong with the vaccines?

Joe and I decided to look into this whole issue when mass vaccination was announced. We submitted our first report [6] to the UK government and the US FDA that was subsequently published in our quarterly magazine. Among other things, we looked into what could be wrong with the vaccines.

In the inactivated vaccines, the main culprits are the contaminants, the cell culture used in growing the vaccine virus, and the adjuvants intended to boost immune response. For the live attenuated virus, the virus itself is a major hazard.

Formaldehyde and propiolactone are chemicals used in killing the virus after they are grown and harvested. Formadehyde is genotoxic and carcinogenic [25, 26], and propiolactone is a potent chemical carcinogen and strongly genotoxic [27].

Dr. Wolfgang Wodarg, German health expert and Chair of the Health Committee of both the German parliament and the European Council, was featured in the press warning against vaccination under the headline [28] “Does virus vaccine increase the risk of cancer?” He probably did not actually say that.  

But on checking out Green Monkey Vero Cells, we found a relevant paper published in the 1980s [29]. The most interesting thing about the paper was the accompanying editor’s statement: “In this paper Contreras et al document the increased malignancy of commonly-used monkey cell lines upon long-term culture. These observations have implications for the use of these cell lines in studies of cancer cell biology, as well as the use of these lines for the production of biologicals. David W. Barnes” (emphasis added).

The research paper actually showed that cells passaged more than 250 times in culture, when transplanted into rats with suppressed immune systems, gave rise to malignant adenocarcinomas.  We don’t know how many passages the Green Monkey Vero cells have gone through by now.

Is the Madin-Darby canine kidney (MDCK) cell line used by Baxter International any better? Probably not; there had been report of malignancy developing in an alkaline culture medium [30]. Genetic instability is associated with all cultured cells, and genetic instability is one major route to malignancy.

It is significant that the new method of growing the vaccine virus in cell cultures has not been approved in the US, as head of National Institute of Allergy and Infectious Diseases Anthony Fauci said [31], and would only be used “if we run into an emergency where we don’t have enough of the egg-based vaccines.”

Although manufacturers of the inactivated H1N1 vaccine are reporting lower than expected yields, Medimmune, subsidiary of AstraZeneca is getting higher than expected yields of its live nasal mist vaccine - about 80 doses per egg instead of just 1 or 2. So it is very likely to be used, and for children.

But the live attenuated virus in the vaccine has all the signs of genetic instability, and will also be able to proliferate in and around the nose. In fact, those vaccinated are advised to stay away from immune-suppressed individuals. The obvious danger is that it could mutate and reassort with other flu strains to generate a really dangerous pandemic virus if mass vaccinations are to go ahead [18].decline12

The adjuvant thimerosal, ethyl-mercury (Et-Hg) as you know, is embroiled in controversy over its suspected link to autism and other neurological defects, and has not been used in vaccines since 2004 in either Europe or the USA, with the exception of flu vaccines. But it is still widely used in all vaccines elsewhere, particularly in the developing world.  A study in Brazil found that by the time the infant is 6 months old, it would have taken in 290 mg of Hg including from breast milk of mothers who take in Hg from contaminated river fish [32].  Vaccinations start at birth, and during the first month, vaccine Hg accounted for 80 percent of its total Hg exposure, amounting to 5.7 to 11.3 mg Hg/kg bw from thimerosal and 0.266 mg Hg/kg bw from breast milk. While mothers showed a 57 percent decrease in total hair Hg during the 6 months of lactation, the infants’ hair averaged a 446 percent increase.

As the researchers pointed out [32], injected Hg in vaccines is far more toxic than ingested Hg. Injected Hg bypasses the barrier and detoxifying system of the gut and liver, and not being physiological processed, it migrates more readily to the brain. Human milk may also have specific neuro-toxic attenuating factors such as long-chain polyunsaturated fatty acids critical for neurite growth and brain development, and cysteine, which is exported by the liver to the brain for intracellular synthesis of gluthathione that provides intracellular defence against Hg induced neurotoxicity. Thimerosal Et-Hg has a half life in blood of infant monkeys about one-third as long as methylmercury (Me-Hg) - an acknowledged neurotoxin - but its concentration in the brain was twice as high, and showed no decline 120 days after exposure [33].  

Squalene is a cholesterol precursor, and is harmless when ingested [34]. But when injected, stimulates the immune system non-specifically A single intradermal injection of this adjuvant liquid can induce joint-specific inflammation in arthritis-prone rats [35, 36], causing erosion of bone and cartilage similar to rheumatoid arthritis in humans that affects more than 2.5 milion in the US. Squalene is also implicated in other autoimmune diseases [37].

Finally, a disclaimer, and a declaration of disinterest. We are not vaccination experts, or even medical doctors and do not give medical advice. The Institute of Science in Society is not a single issues anti-vaccination group, as you can see from our website www.i-sis.org.uk. We provide reliable scientific information to the public, and the science of vaccination is no different from other science. We promote independent science accountable to society and sustainable for the planet and people. We do lots on climate change, renewable energy, organic agriculture, why GM food is dangerous and why we must have genuinely holistic science and holistic health. We publish the quarterly trend-setting magazine Science in Society, which I urge you to subscribe to and get informed to challenge the ‘experts’ on cutting edge science and technology, and to properly advice your governments.

Dr. Mae-Wan Ho and Prof. Joe Cummins

Invited Lecture to Conference Autism is Treatable, 11-13 September 2009, Oslo, Norway.

A fully referenced and illustrated version of this report has been submitted to the US FDA, CDC, and Sir Liam Donaldson and can be downloaded. It is also posted on ISIS’ member’ website. Details here


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