When I started my campaign, sometime in 1985, on the internet from 2000, doctors responded by saying that vaccine safety was beyond question, they were as safe as water. Later as I intensified my campaign and cited peer reviewed published material on risks from vaccines[1], they modified their stance to; well all medications have some risk. Now they fall back upon the risk-benefit analysis meaning that the benefits outweigh the risks. Question is who decides? Must an informed public not be allowed to take that decision? I will touch on this topic in a generalised fashion so that all can comprehend what I am trying to say. 

I will start with the patient rights aspect. Patient rights laws framed after World War II atrocities and subsequent discussions cover not only medical research/interventions but also therapy. According to them there should be full disclosure for all medical prescriptions and procedures and that the subject has the choice to accept the risk or refuse, which is the patient, decides what is suitable for her or him[2]. This is blatantly violated by medical practitioners who feel that it is they who should take the decisions. In case of informed consent on matters of vaccines, in developing countries there is no disclosure though there is a hint in immunisation procedure training manuals that health worker should inform parents that there are risks involved which are not done (Screen for contraindications, Explain potential adverse events following immunization and what to do).[3] In case of developed countries there are only token standardised leaflets that do not reveal the full story as revealed in vaccine package inserts.[4]

Doctors usually avoid talking on the issue of informed consent. But I have been a little persistent. Indian doctors whom I have talked to/corresponded with say that even hinting about a risk might prompt parents not to vaccinate their children. This according to them will severely compromise the vaccination rates. This is a damning statement. So it seems vaccination targets are more important than the life or health of the children. Parents deserve to know the risks that their children face, whom they have conceived and nurtured for nine months in their womb, and on those their entire dreams and aspirations rest, when they are being administered vaccines, singly or in combination.

About risks from vaccines I have pointed out time and again that vaccine risk is a taboo subject that is always avoided; by manufacturers, policy makers and the medical fraternity. When I complained to the WHO patient safety unit about what they were doing to address the subject of ascertaining vaccine risks they replied that the department is never allotted the required funds to do so. Currently this unit is doing a commendable job trying to warn medical professionals about medical errors and their consequences. FDA does the job of surveillance and monitoring – a process that often leads to faulty products that are later recalled.[5] It also ‘fell asleep at the switch’ when it failed to monitor the amount of mercury in vaccines.[6] In an article in "Investigate Hers" - a family magazine from New Zealand where the Gardasil vaccine was probed, Merck employees have complained that the vaccine safety team employed by Merck is not adequately qualified and that Merck too has not appropriately upgraded its laboratories.[7] They said this was undermining the credibility of Merck, a prominent vaccine MNC. Pharmaceutical employees have since then levelled many charges.[8] In India there is no formal vaccine adverse effect reporting system open to the public. The government monitors only those vaccines that are included in the government schedule. It admits that actions on adverse effects noticed are not prompt.

In case of vaccine testing the onus is primarily on the manufacturer. The procedures followed are highly questionable. The vaccines are tested on hand picked healthy children while in real life vaccines are administered indiscriminately to vulnerable, sick, underweight, preterm, immune compromised infants. In these tests the vaccinated children are compared to another group who are either vaccinated with another similar vaccine, with other highly reactive vaccines, with vaccine adjuvants or decontaminants, or with the same vaccine ingredients minus the antigen. This is so the studies can safely declare, "no significant changes were noticed in the vaccinated children vis a vis control groups". The vaccinated children are observed for usually for 14 days, as pointed out by Dr Sherri Tenpenny, or for that number of days till the after effects start appearing.[9] This is a skulduggery that is an insult to the very procedure. Cases of deaths or very severe adverse effects are often excluded citing that other extraneous factors were behind them. For example, in the rotavirus vaccine clinical trial it was observed that the vaccinated children suffered from respiratory tract infections. However this was ignored as "the vaccine could not have possibly caused that". So these trials are more about hiding vaccine risks rather than trying to identify them. In India vaccine trial data proving extreme harm has not been released to the public. [10]

There is a rule stating that there should a monitoring mechanism after the vaccine is licensed and released. In fact vaccines enter the Phase 4 trial after release.[11] However this mechanism is very tardy to say the least in developing countries like India. There is neither the political will nor the medical endeavour to ensure fair and accurate monitoring. In case of the OPV, the IMA in India made the shocking declaration that doctors were advised to ignore and not report cases of paralysis caused by the vaccine. It goes to the credit of the then IMA chief functionaries led by Dr S K Mittal that such a monitoring was done and it revealed that on an average 500 to 600 cases of Vaccine Attributed Paralytic Polio occur every year. The IMA also reported that the OPV was causing cases of Acute Flaccid Paralysis (a condition indistinguishable from polio) to skyrocket and that a vaccine strain virus had attained virulence and was circulating in the population.[12] Just how many children fell a prey to paralysis due to the vaccine and vaccine strains remains a closely guarded secret.

The IMA demanded identification, treatment and rehabilitation of the tens of thousands of victims of the Oral Polio Vaccine but the health ministry did not pay heed and the matter was allowed to die down. The doctors are programmed not to report vaccine adverse effects. They are not informed or taught about serious vaccine risks in their textbooks or are told that serious events are next to negligible. They are also not always knowledgeable about whom to report and are often afraid to do so fearing reprisals from their associations. Only deaths immediately following the vaccines which are brought to the notice of the press ever get reported. But in almost 100% of the cases they are dubbed as "coincidence" or blamed on "program errors" and the vaccine is exonerated. Health care workers will not report vaccine adverse effects as the entire blame is usually put on them and they are punished. However activists have obtained information from the Government that within a 10 year period from 2008 to 2018, 10,612 children have died after vaccination due to Government vaccination drives alone and that there are upwards of 600,000 adverse effects reported every year.[13] Moreover studying just the Pentavalent vaccine, study authors report, “There is likely to be 7,020 to 8,190 deaths from PV each year if data from states with the better reporting, namely Manipur and Chandigarh, are projected nationwide."[14]

Vaccine adverse effects do not occur immediately but may take weeks or months before manifesting as the process is often slow and insidious though the end result may be catastrophic. Thus it becomes very easy to dissociate the event from the vaccine and the cases end up by being termed idiopathic or "cause unknown". Vaccine long term effects may span the lifetime particularly as the inflammatory and autoimmune process set in motion does not stop. Many of the vaccine ingredients lodge themselves permanently in the tissues, fat cells and the brain and continue to inflict a steady and progressive damage. Attenuated live viruses introduced by vaccines may stay dormant for long periods, often mutate, and can become virulent when the immune system becomes weak due to any reason. As vaccines adversely affect the immune system viruses and bacteria present in humans that were not virulent earlier may cause diseases. For example the Hib, which has coexisted since centuries with humans without any adverse effect, but which has become virulent and is now causing meningitis and pneumonia in some immune compromised children and for which yet another vaccine has been devised and is being forced upon the population of mostly developing countries. The entire vaccine controversy is reflected very well in an article in the Indian Journal of Medical Ethics.[15] What is very disturbing is that the very process of reporting adverse effects (The Brighton Protocol) has been changed such that it becomes near to impossible to ascribe them to the vaccine.[16]

The other very dangerous aspect involves animal and human genetic material contamination in vaccines. Such contamination is inevitable, cannot be controlled, and cannot always be traced as our knowledge about zoonotic (animal) viruses is very limited. Till date, despite the intention not to identify the viruses, there has been traced several monkey viruses, bovine and avian leukaemia viruses, porcine viruses, cytomegaloviruses, and the foamy virus and so on in vaccines. No research has been done on their presence, continuation in the human body and mutation or their incorporation into the human genome. SV 40, the Simian Virus, the only one researched into for a short time before the researcher was ticked off and the research stopped, is known to be behind many forms of tumours and cancers in the human body. It is also known to be transmitted to the new generation as it has contaminated the human sperm and most probably breast milk as well. Junk DNA and RNA poses a grave threat as they can incorporate into the human genome by a process known as reverse transcriptase. According to medical scientists this form of threat is the most dangerous that vaccines pose but serious concerns raised by medical scientists are being ignored.[17]

Knowledgeable parents who do their own research genuinely worry about vaccines because of many reasons they have expressed over the years;

• The nature of vaccine ingredients those are highly toxic in nature[18]
• How these toxins interact with themselves in a process called synergistic toxicity is never studied
• The child is given not one but many vaccines
• Often the vaccines are administered simultaneously 
• The safety aspects of such simultaneous administrations are rarely studied
• The complaints of parents of adverse reactions following vaccines go unheeded and they are often mocked at or threatened for raising the subject
• Whether infants, a category with almost no liver activity, with immature immune systems and low kidney efficacy can really tolerate even one single vaccine shot. Studies in other mammalian species have revealed that they cannot.
• Vaccine shots have grown in number from 5 to 6 earlier to nearly 56 doses of 14 different vaccines[19]
• Vaccine damage is extremely expensive to address and families go bankrupt trying to take care of their children
• Doctors do not understand autism and other developmental disorders in children fully and they are programmed to treat them as purely psychological and behavioral disorders of genetic origin. As a result the parents have to research and treat their own children. Doctors who go against the grain and try to biomedically treat these children are being persecuted and branded as quacks.
• The children suffer from lack of communication and so cannot express their pain and discomfort. They cannot take care of themselves, fall behind in their studies, rebel and run away, throw serious tantrums that are difficult to control, suffer repetitive behaviour patterns, and thus are avoided by teachers and nannies and the burden entirely falls on the mother who suffers endlessly.
• The presence of such a child in the family causes tensions often resulting in divorces and separation. There are cases of mothers killing their own children and committing suicide unable to bear the trauma.
• Compensation is not given, or is extremely difficult to obtain (only in developed countries is compensation even considered) as the procedure goes against the interest of the victims and the scientific apparatus have set conditions that almost negate any chance of compensation.
• The US Supreme Court has classified vaccines as "unavoidably risky".[20]
• The parents cannot sue the vaccine manufacturers because of a 1986 law passed by Parliamentarian Bill Frist and supported by Ronald Reagan that indemnifies vaccine manufacturers from law suits.[21]
• It is acknowledged that $ 3.8 billion has been compensated so far to select cases, 83 of them, and subsequently two more, for vaccine induced autism as per expert testimony of those very officials who under oath admit to vaccine damage while negating them otherwise.[22] [23] Two such cases have been awarded in Italy.
• Even then officials will not admit that vaccines cause autism by offering the explanation that the court awards were for "autism like symptoms' and not autism which is strange as autism is till now a symptomatic disorder.[24]
• Vaccines are increasingly being mandated in USA and Europe. Australia has introduced “no jab no pay” policy.
• All efforts are being made to mandate vaccines for school and college admissions even in developing nations and parental exemptions are being made more and more difficult to obtain.
• There is a revolving door between health institutions and vaccine manufacturers. Dr Julie Gerberding, Head of CDC who had steamrolled many a call for enquiry into vaccine safety, today heads the vaccine division of Merck. Dr Thomas Verstraeten of the CDC is today with GSK. Dr Paul Offit of the Childrens Hospital of Philadelphia, a known vaccine lobbyist, has joined the IOM, USA.[25]
• Vaccine decisions are often taken by politicians or bureaucrats who are influenced by money paid into election funds by vaccine manufacturers.[26]
• Medical associations in India have their functions conducted by donations from the pharmaceutical industry which severely dilutes their credibility.[27]
• Latest genetic studies into origins of autism have clearly stated that cases of genetic mutations have been observed which could be due to external, termed environmental, toxins. The Joachim Hallmayer study in September 2011 has doubted the theory being pushed that autism is genetic. The Hallmayer study is the largest done so far conducted upon 900 twins.[28]
• It is a fact that paediatricians depend entirely on vaccines and the resultant illnesses for their income. Unless this issue is settled we are not going to see any perceivable shift in vaccine policy in the near future.[29]
• Current scientific advancements in the subject of microbiome points out grievous harm from vaccines as pointed out recently by Dr Ruth Haley on BBC.[30]
• Whenever a safety issue is raised it is negated with manipulated studies and the researchers are vilified. Currently researchers are publishing under pseudonyms to escape repercussions.[31]

So the overall picture is that vaccine safety is not even low rung priority of any of the stakeholders, except for the public for whom it is the one and only priority. In India, I have had access to meeting records where vaccine policies are discussed and I can declare that vaccine safety is not usually even touched upon. The whole thrust is on introducing new vaccines and of ways to finance the decisions. However the Government has under pressure removed BMGF representatives and UN consultants from certain key positions.[32] [33] WHO is currently trying to force the controversial HPV vaccine onto India and the Government is yet to give in.[34]

Vaccine effectiveness has been questioned in published literature. According to a published study vaccine induced antibodies do not necessarily translate into immunity.[35] Cases of measles, whooping cough and mumps outbreaks in fully vaccinated children have been reported in many countries.[36] Vaccine preventable disease outbreaks are blamed on non vaccinated children without releasing key information about the disease outbreak in vaccinated children. The herd immunity argument used to push vaccines into the maximum number of children has been questioned as it is not based upon scientific evaluation. [37] Whereas countries such as Japan and Sweden concede cases of vaccine adverse effects and pay compensation, those vaccines continue to be administered in other countries. Vaccine batches rejected in developed countries are not destroyed but shipped to developing countries. Companies have reportedly even intentionally shipped infected ingredients of vaccines so as to cause global outbreaks of diseases mandating further vaccines (the Baxter incident).[38]

Thus we are compelled to come to the conclusion that the risk versus benefit analysis that the vaccine lobby puts forth to promote this highly controversial procedure is seriously flawed. Vaccine risks are ignored and benefits are exaggerated to push more and more vaccines into the schedule of both developed and developing nations