Adjuvants with severe physiological side effect have been administered to hundreds of children during vaccine trials conducted at a government hospital in Indore over the last few years, and that too without the approved Standard Operating Procedure (SOP).
The trials conducted on at least 836 children at the Chacha Nehru Bal Chikitsalaya, the paediatric division of the Maharaja Yashwantrao Hospital, were spiked with adjuvants that contain high levels of mercury, aluminium, detergents, pesticides and human carcinogens.
Banned by FDA
An adjuvant is used to spike a vaccine to boost its impact and amplify the body's immune response to the vaccine.
Two of the adjuvants used, Thimerosal and Squalene, are banned by the Food and Drug Administration (FDA) department of the United States. In India, there is still no protocol regarding the use of adjuvants.
Thimerosal, which contains 49.6 per cent mercury, can be so dangerous that vaccines in several Western countries are branded as Thimerosal-free. Its side effects include neuro-developmental disorder, autism, attention-deficit hyperactivity disorder and speech delay, while Squalene can cause the Gulf War Syndrome and dementia.
“In special cases, the maximum recommended dose of Thimerosal is 1 mcg [microgram], while these children at CNBC were administered doses of 25 mcg,” said whistleblower Anand Rai, who accessed the information under the Right To Information Act.
Other adjuvants used include Tween-80 (detergent), 2-Phenoxyethanol (pesticide), Formaldehyde (carcinogen), and Amorphous Aluminium Hydroxyphosphate Sulphate (aluminium).
The adjuvants were administered along with vaccines such as HPV 503 cervical cancer vaccine, H1N1 flu vaccine, hepatitis vaccine, easy five vaccine and Imovax polio vaccine.
The trials were conducted without the required SOP by hospital paediatrician Hemant Jain.
Schedule Y of the Drugs and Cosmetics Act, and the 2006 guidelines of the Indian Council of Medical Research, require the SOP to be cleared by an Ethics Committee before the commencement of any clinical trial.
In reply to an RTI query, Dr. Jain stated: “To the best of my knowledge, none of the adjuvants used to boost the immunity of vaccines has any clinically significant side effect.”
However, when contacted by The Hindu about the fact that the administered adjuvants had harmful ingredients such as mercury, pesticides and carcinogens, Dr. Jain expressed ignorance.
“I don't know anything about the contents of the adjuvants, but they have always been used with vaccines. You should ask the companies about adjuvants,” he said.
Even the adjuvants used on children in Indore that are not banned by the FDA have side effects — termed insignificant by Dr. Jain — ranging from skin irritation, hypertension and irritable bowel syndrome to brain damage, Alzheimer's, infertility, genetic mutation, hypertension, acute renal failure, convulsions and damage to the central nervous system.