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US Government Owns Patent of Lethal Indian Rotavirus Vaccine

India VaccineBy John Stone

The patent of the rotavirus vaccine Rotavac  – the present subject of controversy  in India - is owned by the US Department of Health and Human Services. The Indian government have refused to either end trials of the vaccine or publish crucial data from the original trial which would shed light on the occurrence of an exceptional number of cases of the life threatening condition intussusception in which a section of the intestine collapses into itself. The vaccine is being created by a partnership between the US National Institutes of Health, the Bill and Melinda Gates Foundation, India’s Department of Science and Technology, PATH  and the manufacturer Bharat Biotech. All versions of rotavirus vaccine to date have been associated with increased incidence of intussusception: the first version Rotashield, manufactured by Wyeth, was withdrawn in the US after a year in 1999. Two successor versions, Merck’s Rotateq (part developed by Paul Offit), and GSK’s Rotarix were recently taken off the schedule in France, following incidents.

Dr Jacob Puliyel of St Stephen’s Hospital Delhi - a leading critic of program – has argued that initial the Indian trials produced results three times as bad as the withdrawn Wyeth vaccine: he wrote on Pubmed Commons :

With the 116E vaccine trial there were 6 cases of intussusceptions in 2267 controls which works out to be 2.6 cases per 1000 placebo recipients. The ‘normal rate of intussusception’ in this study was at least 10 times higher than the RotaSheild trial (where it was 0.2 cases per 1000 placebo recipients). There were 17 cases of ultrasound confirmed intussusceptions among the 4532 given the 116E vaccine which is 3.75 cases per 1000 babies vaccinated. The comparative figure for the RotaShield study was 0.5 cases/1000. In the 116E trial there was an excess of 1 case of intussusceptions for every 1000 children vaccinated with the rotavirus vaccine (compared to the RotaSheild trial where there were 3 excess intussusceptions per 10,000 vaccinated). RotaSheild vaccine was withdrawn after licensing, on account of unacceptable risk of intussusception. The risk of intussusception in the 116E trial was three times higher than with the RotaSheild trial. We are told that in the 116E trial, 50% intussusceptions diagnosed by ultrasound, resolved spontaneously John J, 2014. In the remaining 50% there is need for urgent treatment by a radiologist or pediatric surgeon. In remote parts of India, without motorable roads, let alone radiologists and pediatric surgeons, mortality will be near 100% http://emedicine.medscape.com/article/930708-overview. Such specialized care (radiological or surgical reduction of intussusception) is not available in vast swathes of India and we can assume vaccinated babies would die at home passing blood and mucus in the stools and it will be presumed they had died of dysentery and sepsis rather than intussusception caused by the vaccine.

Proponents of the vaccine have argues spuriously that the trial was too small to deduce anything about adverse reaction,  instead – which is more to the point - of the problems being too gross to hide even in a small trial. Meanwhile, data is withheld and it is proposed to conduct a much larger trial on a hundred thousand infants regardless.

John Stone is UK Editor for Age of Autism.


John Stone


This is what Dr Puliyel had to say about effectiveness:

"Assuming only 50% ultrasound diagnosed intussusceptions need urgent treatment John J, 2014 we can assume that one child in 2000 vaccinated babies will develop this life threatening condition. The possible harm in remote areas (deaths from intussusceptions 1/2000) is not offset by benefits (diarrhea deaths avoided using the 116E vaccine).

"In the first two years after vaccination, there number of infants that needed to be immunized to prevent one episode of rotavirus diarrhea of any severity was 21 Bhandari N, 2014. Assuming mortality from rotavirus diarrhea to be 1% in the first 2 years of life with community management Lal S, 1994 Kosek M, 2003 2100 babies will have to be vaccinated to prevent one death from diarrhea in the first 2 years of life.

"When 2100 babies are vaccinated to prevent that 1 death from rotavirus diarrhea - 1 child will have intussusceptions and die in remote areas of the country. This is why, given the limited evidence of this 116E trial, licensing the vaccine for general use (in remote areas of India), seems impossible to justify."


Chloe Mica

Hope it will be effective!

Jeannette Bishop

"Proponents of the vaccine have argues spuriously that the trial was too small to deduce anything about adverse reaction..."

So they want more data to better determine risk factors to facilitate "good" vaccine research (as Paul Offit dubbed vaccine autism epidemiology) in the future?

Why go forward, never minding that a small sample might under-represent a risk and they likely already screened out infants of greater risk for these trials, so I doubt the results over-state the harm this vaccine will do? What influence persuades the Indian government to participate?

John Stone

Thanks Lou - very interesting document. It is like the only thing that ever gets learnt from such investigations is how smash the rules even more effectively.


Mr Conte
Thank you for the post.
I wonder if any of the recommendations from that congressional report were adopted.
The conflicts of interest the report mentions are pervasive and extraordinary.

Louis Conte

The rotavirus vaccine has a twisted and corrupt history as the 2000 Congressional Report details:


It is sickening that more children are dying due to this drug and those who promote it.

Angus Files

Horrendous in every way..and the only concern to the Lancet is "breast feeding"...


Beam me up!!Scotty..


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