By TLB Staff Writer: Christina England
According to recent reports, India is planning to reevaluate the new rotavirus vaccine being used in vaccine trials across the country. The decision was made after a number of children suffered severe complications after receiving the vaccine, which was released earlier this month.
The Hindu reported that the vaccine, which was given to vulnerable children in India to prevent them from suffering severe diarrhoea, has been associated with intussusceptions, a condition that can cause them to suffer from intestinal blockages.
According to their report, an advocate of safe vaccines, Dr. Jacob Puliyel, a paediatrician at St. Stephen’s Hospital, Delhi, told reporters:
“The vaccine has shown associated risk of intussusceptions, a condition that could cause bowel obstruction and may need surgical treatment.”
The exact number of infants injured, however, remains a mystery, as the data has been withheld, despite requests from an international scientific journal.
Dr. Jacob Puliyel stated that:
“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.”
Parents need to ask themselves why this data is being withheld; if the vaccine is safe, then officials have nothing to hide. Surely, it makes sense to reveal the figures to reassure parents.
In a bid to get to the bottom of this mystery, The Hindu also attempted to obtain the data, however, they, too, were unsuccessful. They wrote:
“The Hindu also contacted those involved with the previous study for this specific detail and was told “the study is in public domain and has the percentage of children who indicated vaccine-related risk of intussusceptions,’’ but none of the members actually provided the exact number of children (from Delhi, Pune and Christian Medical College, Vellore) who demonstrate this adverse reaction to the vaccine.
Researchers involved in the clinical trials note that these concerns ‘have little relevance.’”
If the figures ‘have little relevance,’ then what is the big secret? Does the government have something to hide?
Whatever the risk, it appears that the Indian government are carrying on with the program, regardless. This was stated very clearly by Professor Gagandeep Kang, of infectious diseases at the Christian Medical College, Vellore, when he told reporters:
“Under the new study one lakh infants will receive three doses of the oral vaccine for a year so that the intussusceptions risk can be measured more precisely.”
Governments Have Known the Risk for Years
Amazingly, in 2010, the FDA reported that children vaccinated with the first dose of the rotavirus vaccine Rotarix, manufactured by GlaxoSmithKline, were at a slightly higher risk of suffering from the bowel complication intussusceptions. They stated that this was discovered after a trial of the vaccine took place in Mexico. In a press release, the FDA wrote:
“On September 22, 2010, FDA informed healthcare providers and the public that it had approved revised Prescribing Information and patient labeling for Rotarix, a vaccine manufactured by GlaxoSmithKline Biologicals (GSK) for the prevention of gastroenteritis caused by rotavirus infection in infants 6 weeks to 24 weeks of age. After FDA completed an evaluation of preliminary results from a post-marketing study conducted in Mexico, information was added to the existing intussusception (a form of blockage of the intestines) subsection of the Warnings and Precautions section. The interim analysis of this study suggested an increased risk of intussusception in the 31 day time period after the first dose of Rotarix (relative risk of 1.8 with a 99% confidence interval of 1.0 to 3.1).
These findings translated to potentially 0-4 additional cases of intussusception hospitalizations per 100,000 vaccinated infants within 31 days after the first dose of Rotarix in the United States. This took into consideration the rate of the natural occurrence (without vaccination) of intussusception hospitalizations in the United States, which is approximately 34 in 100,000 infants in the first year of life.
Further analysis showed that the increased number of intussusception cases occurred primarily within seven days after the first dose.
This information was also included in the Post-marketing Experience subsection of the Adverse Reactions section of the prescribing information and in the information for the patient.”
Interestingly, unbeknownst to parents, the same risk has also been observed in the US. The FDA stated:
“The Mexico study did not take into account all medical conditions that may have predisposed infants to intussusception. However, if an increased risk for intussusception following administration of Rotarix similar to that observed in Mexico does exist in the United States, it is estimated that approximately 1 to 3 additional cases of intussusception hospitalizations per 100,000 infants in the United States might occur within 7 days after receiving the first dose of Rotarix. This takes into consideration the yearly rate of the natural occurrence (without vaccination) of intussusception hospitalizations in the United States of approximately 34 in 100,000 infants less than 1-year of age. Studies to assess the risk of intussusception following administration of Rotarix in infants in the United States are currently underway.”
In other words, there is a small risk, but the FDA will recommend the vaccine regardless, and, to keep themselves safe from prosecution, they will cover their backs by including the risk in the adverse reaction section of the prescribing information.
PATH Admit There is a Risk of Intussusception After Rotavirus Vaccines
In a document titled Rotavirus Vaccine Access and Delivery, written by PATH, an organization said to be a leader in global health innovation, they clearly indicate a known link between rotavirus vaccines and intussusceptions. Point 7 of a section titled Rotavirus Vaccine Safety and Potential Side Effects stated:
“7. Is there a link between rotavirus vaccines and intussusception?
Yes. Studies have been conducted in Australia, Brazil, Mexico, and the United States to assess safety following the introduction of Rotarix® and RotaTeq® rotavirus vaccines. Results from these studies show a potential low-level risk of intussusception shortly after the first or second dose of rotavirus vaccine:
Table 1. Estimated risk of intussusception and benefits of rotavirus vaccination in Australia, Brazil, Mexico, and the United States
The following information (Table) is displayed in this fashion: Country – Diarrhea hospitalizations (deaths) prevented by vaccination – Intussusception hospitalizations (deaths) potentially caused by vaccination
Australia … 7,000 (0) … 6 (0)
Brazil … 69,600 (640) …55 (3)
Mexico … 11,600 (663) … 41 (2)
United States … 53,444 (14) … 35-166 (0.1-0.5)
Note: Table is derived from Table 6 in Yen et al, 2014. Estimates are for one fully vaccinated birth cohort followed to age 5 years.
However, the World Health Organization (WHO)’s Global Advisory Committee on Vaccine Safety, the US Centers for Disease Control and Prevention (CDC), the US Food and Drug Administration, the European Medicines Agency, and immunization advisory committees in countries with published intussusception studies have reviewed the data and determined that the benefits of rotavirus vaccination to prevent severe rotavirus diarrhea outweigh the low-level risk of intussusception. 12;14-16;46;53 WHO, CDC, and immunization advisory committees in countries with published intussusception studies have upheld their recommendations to administer rotavirus vaccines to infants to prevent severe rotavirus diarrhea.”
Parents should consider whether or not the Rotavac vaccine being used in the Indian trials is any different.
Although adverse reactions to this vaccine were said to be no higher than the adverse reactions to the placebo, no one actually knows what the placebo was. For example, if the placebo given in this trial was in fact another brand of the rotavirus vaccine, the results in point 11 make perfect sense, because …
“During the Phase 3 clinical trials of the vaccine, infants receiving ROTAVAC® did not experience a significantly higher level of adverse events compared to infants receiving placebo.”
It is clear that intussusception is an adverse reaction seen after both the Rotarix vaccine and the RotaTeq vaccine, therefore, if one of these vaccines was used as the placebo in the Rotavac trials, this would explain why infants receiving this vaccine did not experience higher rates of adverse reactions.
Conclusion
It appears that, once again, vulnerable infants from developing countries are being used in vaccine trials. If there was not a problem with this vaccine, then why is crucial data being withheld from professionals and the public?
If data is withheld, then this can only lead parents to suspect that, yet again, this vaccine cannot be trusted. This is especially worrisome because a doctor from India advocating for safe vaccination clearly told reporters that: “The vaccine has shown associated risk of intussusceptions, a condition that could cause bowel obstruction and may need surgical treatment.”
Surely, it is in everyone’s best interest to halt the trials immediately. It is clear that the truth about the dangers are being hidden and that this vaccine is far from safe.
An Indian colleague told The Liberty Beacon:
“This is a serious charge! The trials of the indigenous Rotavirus Vaccine in India have revealed something suspicious – that the rates of intestinal blockage in children after being administered the vaccine may be very high in susceptible populations. This data is not being released despite this trial being funded by the Government. Also the risks from the vaccine were originally observed to be 1 in 10,000 – an unacceptable level – and this trial was conducted on 4000 children! We do not know what ‘placebo’ the control of 2000 children received. Was it a genuine placebo or an earlier Rota vaccine? Why is the data being denied? Moreover, when the re-evaluation is taken up, the vaccine will be administered to the public without controls! How do you measure the adverse effects then! Is this route being taken to hide the unsafe nature of the vaccine?” Buyers beware!
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