The 'vaccinegate' of Italy

A study in Italy has found major contaminants in vaccines that are used the world over
The 'vaccinegate' of Italy

Since January, Italy is witnessing a “vaccinegate”. In 2017, a lab in the country started studying seven common vaccines that prevent diseases like polio and hepatitis B. The results on four of the vaccines were released in December 2018 and have been in the news ever since, with even the country’s parliament discussing them. The results show that not only all four vaccines carry contaminants, one does not even have the antigens in the form that can be absorbed by the body to develop immunity towards the target diseases. The four vaccines are used across Europe and even in India.

What triggered the study was a law passed in 2017 by the Italian government mandating childhood vaccination. The law was opposed by Corvelva, an advocacy group of independent researchers that has been demanding freedom to choose vaccines since 1993. On October 26, 2018, the Italian National Order of Biologists (known as ONB), a 50,000-member association, announced a grant of US$11,350 to Corvelva to undertake the study, which gave credibility to the protests and the study. Though the results have not been published by any peer-reviewed journal so far, the findings, if true, are quite alarming.

Loaded with impurities

The tests found that Infanrix Hexa, manufactured by England-based Gla xo Smith Kline (GSK), and used for protection against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B and Haemophilus influenzae type b (Hib) did not have antigens in the right form. “The antigens are not present as soluble proteins as they are supposed to be, but as insoluble macromolecules. Due to the insolubility, they will not be recognised by the immune system of the body. Hence the efficacy is doubtful. Also, its stay in the body can cause unknown toxicity,” says Loretta Bolgan, a consultant of the Italian parliamentary commission on army personnel and an expert on vaccination damage. She is also associated with Corvelva (see ‘The results should trigger rigorous research’ on p18) and says that the organisation is calling the episode “vaccinegate”.

Jacob Puliyel, a paediatrician at St Stephen’s hospital, New Delhi, published a paper in the Indian Journal of Medical Ethics in September 2017 on post-vaccination deaths in Italy on the basis of Periodic Safety Update Report (PSUR)15 pertaining to data for 2009-11 that GSK submits to Italian courts every year. “As per PSUR-15, 42 deaths took place in the first three days after vaccination, and only 8 in the next 3 days. Among those below one year of age, 54 deaths (93%) occurred in the first 10 days, and 4 (7%) in the next 10 days...The fact that the rate of death decreases rapidly with the passage of time following immunization suggests that the deaths could be related to vaccination,” states the paper.

Tests on the vaccine Priorix Tetra, also manufactured by GSK, and used for protection against measles, mumps, rubella and varicella, showed that it contained 1.7-3.7 microgram of foreign chicken embryo DNA and human foetal DNA. This is at least 100 times more than the World Health Organization (WHO) limit of 0.01 microgram. Foreign DNA comes from cells used during production of vaccines but should not be present beyond the prescribed limits when the vaccine comes to market. Beyond the prescribed limit, foreign DNA can even cause cancer, says WHO. Foetal DNA can integrate in the host DNA of the recipient and cause mutation.

Tests on the human papilloma virus (HPV) vaccine, Gardasil 9, manufactured by Merck and Co of the US, was found loaded with bacterial DNA. “54 per cent of the total DNA of the vaccine was bacterial. While it may come from yeast which is used as culture, it can also come from laboratory contaminants,” Bolgan says. The report also points out the presence of human and mouse DNA! While human DNA could have come from the HPV virus taken from human tissues, the mouse DNA could be a cross contamination from cells used for production of other vaccines. Tests also found aluminium, used as adjuvant to enhance the immunogenic capacity of the vaccine, in the samples. Aluminium can be neurotoxic, genotoxic and immonotoxic.

The Hexyon vaccine too, which protects against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Influenzae B, was found contaminated with monkey DNA. Tetanus phage (a virus that can replicate with bacteria) was also found, which can cause autoimmune diseases, especially if bound to aluminium present in the vaccine. The vaccine is produced by Sanofi Pasteur of France. Emails sent by Down To Earth (DTE) to GSK and Sanofi Pasteur remain unanswered.

While Merck and Co said: “MSD is aware of the Corvelva report about the test of a specific batch of GARDASIL 9 and is in the process of reviewing it. We stand behind the efficacy, safety and quality of the vaccine because all of our products are manufactured according to current Good Manufacturing Practices and meet all license requirements.”

“MSD performs testing on all vaccine batches, including the subject batch, prior to release to ensure all specifications are satisfied, confirming the quality, safety and efficacy of each manufactured batch. Each batch of vaccine introduced to the European market is also submitted for independent testing and certification to the Official Medicine Control Laboratory (OMCL) of the European network, which are independent laboratories that perform release tests, including for composition and purity, to support regulatory authorities in controlling the quality of medicinal products.  Accordingly, the batch of GARDASIL 9 referenced by Corvelva, as per European statutes, was tested and released by the OMCL of reference, the National Institute for Biological Standards and Control (NIBSC) Regulatory Control Body UK, and was found to fully conform to all specifications, including composition and purity,” they added.  

The deniers 

When Corvelva sent the results of the tests to the Italian regulatory body, Agenzia Italiana del Farmaco (known as AIFA) in August 2018, it raised doubts on the credibility of the tests. In its reply in November 2018, AIFA said that vaccines are subjected to testing standards as per guidelines provided by the European Medical Agency during registration phase and the verification of compliance is also monitored by laboratories accredited by the European Union (EU). However, ONB president Vincenzo D’Anna said that most studies in public labs and universities are influenced by companies and there was a need for a truly independent vaccine research, according to report published by the journal Nature on December 13, 2018.

What now?

Authorities and governments are circumspect in their response to the tests. In reply to an email, the American Academy of Pediatrics (AAP) told DTE, “AAP does not typically review information about a non-USA based company. This appears to be more of a federal regulations issue.” An email to the Drugs Controller General of India (DCGI) went unanswered.

A faculty member of the National Institute of Immunology, Delhi, also refused to comment saying the methodology and other aspects of the study need to be looked into.

“It’s not that the Indian authorities do not know about this. According to the rules of DCGI, drugs approved in the US, UK, Canada, Japan, Australia and EU are considered approved in India. Keeping in mind the weak surveillance systems in India, it’s time the government reacted to these results,” says Puliyel.

'The results should trigger rigorous research'
LORETTA BOLGAN is an expert on vaccination damage and is associated with Corvelva, the Italian organisation that tested seven common vaccines used globally. Down To Earth spoke to her about the findings

Did you seek a response from the manufacturers?

We never had any feedback from manufacturers.

What has been the response of the doctors concerned?

Here in Italy, there is a sort of silence in dealing with the issue of vaccinations. Recently several Italian doctors have been scolded and suspended for questioning mass vaccinations as a practice, without even questioning the effectiveness of the vaccines. In fact, today in our country, it is forbidden to talk about vaccines in a "critical" way, let alone questioning their safety and effectiveness. Therefore, it is easy to understand how the only voice that can be heard, right now, at the level of the scientific community, is that which fully adheres to the dogma of "clean, safe and effective vaccines".

Tell us something about Corvelva?

It is an association of parents and researchers that has seen a great participation in the last two years, after a new law on the compulsory vaccination arrived, exploiting a measles epidemic which was perfectly in line with the cyclical waves that can be expected with such endoepidemic disease. The law provides as many as 10 mandatory vaccines for all individuals aged 0 to 16 years. This led to large protests among the population in defense of freedom of choice, considering that access to kindergartens is precluded to unvaccinated children today. Corvelva has decided to invest the funds deriving from the association fees and donations in the analysis of the vaccines given to the Italian paediatric population.

How do you respond to the fact that no peer-reviewed journal has published the study yet?

We have put our results for publication on F1000Research, an open access platform. The independent referee has asked us to give more information. We are working to answer to peer reviewer requests without problems. We will know if it will be accepted only at the end of the peer review process. A certain section of scientists have spread the word that our work has been rejected during peer review. It is false.

A number of scientists and doctors, especially in Italy, have not confirmed your findings.

We are not concerned with that because many conflicting interests are at work. So far all that they have done is criticise the methodology in generic terms. But they have not come out with specifics. It requires massive funding to do further analyses. Our results should at least become trigger for the medical science to start doing rigorous research.

 (This article was first published in Down To Earth's 16-28 February, 2019 print edition)

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