Please sign and circulate petition, and read new article at CHS.
Vaccine safety proponent Jacob Puliyel (consultant paediatrician at St Stephen’s Hospital, Delhi) has drawn attention in the Hindu newspaper to malfeasance in trials for an Indian rotavirus vaccine. It is proposed to conduct a trial involving 100,000 infants when the data from an earlier smaller trial has been suppressed (the report refers to a lakh which is an Indian unit of 100,000). Puliyel comments in the report:
“Peer reviewed journal Vaccine, published a letter written by me and a colleague, asking for disaggregated data on the number of intussusceptions in Vellore in the randomized control trial during the 2 year study period. The protestation of the authors that the vaccine is safe has little meaning if they do not provide the data. However, the data is not available in the papers published and the peer reviewer of Vaccine and the Editor of this international journal felt that it needs to be provided. Serious concerns are raised if safety data in a vaccine trial done with Government of India funding is not provided in spite of a call for it in an internationally indexed scientific journal.”
In an earlier intervention on Pubmed (14 August 2014) Puliyel quoted actual figures:
Licensing the vaccine for general use (in remote areas of India), seems impossible to justify
I commend Dr John and colleagues for this report on the trial with the 116E Indian rotavirus vaccine. However the authors limit their discussion to comparisons with the trials of Rotarix and Rotateq which recruited some 60,000 patients each. It will be more useful to compare the 116E trial safety results with the RotaSheild vaccine trials http://www.path.org/vaccineresources/files/RotaShield_Fact_Sheet_CDC.pdf.
The RotaSheild trial recruited double the numbers recruited in the present 116E study. RotaSheild was licensed after the trial involving 14,687 patients (10,054 received the rotavirus vaccine and 4,633 received placebo). In the study there was one case of intussusceptions among the 4633 receiving placebo. This suggests that the ‘normal rate of intussusception’ was approximately 2/10,000, in that population. Five cases of intussusceptions occurred among 10,054 RotaSheild vaccine recipients. Thus there were an excess of 3 cases of intussusceptions for each 10,000 children vaccinated. All the intussusceptions were among infants who received a second or a third dose of vaccine. The difference between the vaccinated and placebo recipients was not statistically significant http://www.path.org/vaccineresources/files/RotaShield_Fact_Sheet_CDC.pdf.