The row over the Indian rotavirus vaccine Rotavac being developed by Bharat Biotech is continuing. Jacob Puliyel, paediatrician at Delhi’s Stephen’s Hospital, had been drawing attention to an excess of intussusception cases in the vaccinated group in a trial of the new vaccine and is calling publicly and in a petition for the raw data to be published. Intussusception is a blockage of the intestine associated with all rotavirus vaccines but the early figures for the Indian product seemed to be dramatically worse than for earlier versions.
In June in the British Medical Journal reported:
Gagandeep Kang, professor of gastrointestinal sciences at Christian Medical College, Vellore, who worked on the trial, said that the trial data cannot be used to estimate the risk of intussusception from the vaccine as the campaigners have argued. “This was not a study powered to detect rare events. If you want to find the rate of intussusception, you need to evaluate the vaccine in hundreds of thousands of children,” she told The BMJ.
It is not, however, clear why the study would be useful to study efficacy and not safety, particularly as unfortunately the events do not seem to be rare. Meanwhile Bharat Biotech, the Indian Government and World Health Organization are determined to plough on with a larger trial which could injure more children. Dr Puliyel has written in the electronic responses of the BMJ:
Dr Kang does not provide the data that will allow easy calculation of the risk in Vellore but she quotes the WHO reporting that “existing data on Rotavac do not point to an increased risk from intussusceptions”. The data, when provided, will speak for itself and we do not have to rely on the say-so of the WHO.
The authors have published aggregated data from the 3 centers where there was no statistically significant difference in intussusceptions in vaccine recipients and controls. Dr Vijaya Raghavan of the Department of Biotechnology (DBT) under whom the multi-center trial was done, says that the disaggregated data has been provided to the National Technical Advisory Group on Immunization (NTAGI). As a member of this apex advisory body of the Government of India, I can say that I have requested this data and it has not been provided to the NTAGI as yet. Dr Vijaya Raghavan goes on to say that in response to various queries that they have received he will ensure “data is available for analysis by a competent body, meeting the requirements of analytical rigor and transparency.” As the analytic skills needed here are very basic and the aggregated data is already in the public domain, it is not clear only a DBT-selected ‘competent body’ can be privy to the Vellore figures.
The petition can be signed here.
A letter in the same column casts further light on the decision of the authorities in France to remove the recommendation for the use of the existing rotavirus vaccines RotaTeq (the vaccine developed by Paul Offit for Merck/Sanofi) and GSK’s Rotarix after they place on the schedule in 2013 which we also reported in April . Claudina Michal-Teitelbaum MD writes :
The French Technical Committee for Pharmacovigilance met and issued a first report on December 9, 2014 on rotavirus vaccines safety monitoring and transmitted it to the National Agency of Drug Safety (ANSM). Despite alerting observations of the committee about the vaccine safety the agency didn’t throw alert until March..30, just a few hours before the information was published in a satirical newspaper. The committee expressed concern about the worrying rate of serious side effects notifications with the two vaccines and questioned about the appropriateness of recommendations. It pointed specially to two deaths following vaccination due to very severe forms of intussusceptions. It also took into account a third death following rotavirus vaccination due to necrotizing enterocolitis in an infant treated by Varitect® (a human varicella-zoster immunoglobulin) . A final report by the pharmacovigilance comettee [sic] was issued in February…It was estimated that 491000 infants had been vaccinated since 2006. In total, there were 508 side effects notifications (103.8/ 100 000) of which 201 serious side effects ( 39.57%, 40.9/100 000). 75% of the total side efffects were digestive . There were 47 intussusceptions too and among them 14 (29.80%) required chirurgical [surgical] treatment. Most of them occurred after the first dose and the median age for post-vaccinal intussusceptions was 3 months… 21 of the 35 cases of intussusceptions with the vaccine Rotarix occurred during the first 7 days following vaccination and 6 of 12 for Rotateq. Two of the infants with intussusceptions died, one was vaccinated by Rotarix and the other by Rotateq. The infant death caused by Rotarix occurred in 2012 but GSK, in charge of the enhanced pharmacovigilance plan for Rotarix as it was allowed by the 2010/84/UE directive , declared it to public pharmacovigilance only in December 2014…
She also points out:
It is noteworthy that clinical trials have never demonstrated a reduction in all cause mortality with these vaccines, neither in high nor in low income countries.
John Stone is UK Editor for Age of Autism.