On October 11, two children died in Kashmir after receiving the Pentavalent vaccine, taking to six the total deaths there in one week and to eight the deaths over the last three weeks. According to reports appearing in local newspapers, the deaths were said to be an allergic reaction to the vaccine. These deaths come on the heels of a press release from the health ministry on October 10 that a committee that looked into the 15 deaths in Kerala after vaccinations has said they were not caused by the vaccine but were coincidental deaths. The press release also announced that the Pentavalent vaccine is to be rolled out nationwide. A week earlier, another ministry spokesperson had admitted there had been 29 deaths all over the country following the vaccine. The figure has now ballooned to 37.
The 29 deaths had happened when 82 lakh doses have been administered (and about 27 lakh children have been immunized). This works out to more than one death per 100,000 vaccinated and that 300 children would die each year from the vaccine when the birth cohort is vaccinated. It must be borne in mind that the adverse events are picked up by a system of passive surveillance which according to the US FDA picks up only a tenth of the real number of adverse events.
Co-morbidity as cause of death
It has been suggested that some of the deaths in Kerala had happened in children with an underlying heart disease. Many children who died in Sri Lanka after receiving the same vaccine also had a similar heart condition. Had they not been vaccinated, the death rate from the vaccine would have been less.
However this is no practical proposition. Vaccinations are given in distant rural areas by health workers who are barely literate. The detection of heart murmurs by auscultation is a skill that many pediatricians have to hone over many years of training. In the absence of such training for all vaccinators, can we justify continuation of the vaccination programme?
In Sri Lanka vaccination was stopped after five deaths. Under pressure from international organizations the programme was restarted. After that, there have been 12 more deaths. Dr. Yogesh Jain, who has filed a PIL in the Supreme Court, has sought the court's oversight to prevent such pressures from influencing decision-making in India.
The deaths from vaccine must be seen in the context of hard data from the best study on Hib (Haemophilus influenzae type b bacteria) in the country called the Minz study which suggested that some 175 children die from Hib meningitis in the birth cohort over five years and perhaps an equal number from Hib pneumonia. These figures from this large, meticulous community based study done in a population of 600,000 with house visits every two weeks and conducted over two years are clearly inconvenient. This is a case of the cure (vaccine deaths) being worse than the disease. The government seldom quotes the Minz study data, but relies instead on estimates that are not based on empirical evidence.
Central team declares vaccine safe in Kashmir
With practiced efficiency, after the eight deaths in Kashmir, a central team under Dr. N.K. Arora, who works for Inclen Trust, went to the state, visited the hospital and the homes of the dead children and issued a press release that there was no conclusive evidence that the deaths were due to the vaccine. Septicemia, pneumonia and meningitis were blamed, without explaining how children who were completely asymptomatic and well enough to be given routine preventive vaccination by healthcare personnel, could die of septicemia or pneumonia immediately afterwards. In other words, how could children gasping for breath with pneumonia or in shock due to septicemia and about to die in the next few hours be given Pentavalent vaccine by the healthcare personnel?
To be sure that the vaccine is the cause of a reaction, the same reaction must recur in the same person if he/she is given the same vaccine a second time. As this type of re-challenge is impossible when the reaction results in death, the expert team declares that "causative relation to immunization cannot be established with certainty". It is nearly as if we are saying we will not believe the vaccine is "causative related" unless one child is resuscitated from the dead and then re-challenged to see if he will die a second time!
We need to use the same strict criteria and apply the same burden of proof when we say the deaths are due to Sudden Infant Death Syndrome (SIDS) or due to co-morbidity or due to preexisting septicemia or pneumonia. This we do not do.
Posers from the Indian Academy of Pediatrics
The Indian Academy of Pediatrics (IAP) recently held a meeting to look into the deaths and posed the following questions to the health ministry:
* As the peak incidence of SIDS occurs in early infancy, a close temporal relationship between this and receiving Pentavalent vaccine is expected by simple chance and, therefore, it may not be right to attribute the deaths in Kerala to SIDS.
* The deaths attributed to SIDS in Kerala are five times greater than the all-cause mortality rate in the state. What is the possible explanation for this spurt of deaths after introduction of Pentavalent vaccine?
* The peak age of SIDS is the third month (corresponding to the second dose), but the majority of deaths were reported after the first dose.
* The co-morbid conditions resulting in death following vaccination have not been clarified.
* Why the vaccine is being given to sick children is not explained.
* Underlying congenital heart diseases used to explain away the deaths were not serious enough to cause cardiac failure and death.
* Some children had high fever and excessive crying; some had convulsions after vaccination which can definitely be attributed to adverse events following immunization.
* Autopsies suggested hypersensitivity and shock - how should that be interpreted? Does it mean hypersensitivity to the vaccine?
The IAP discussed these with Dr. Ajay Khera, deputy commissioner (Maternal and Child Health) at the health ministry, who was unable to give any clarifications saying the final report of the enquiry committee on the deaths was awaited.
Yet an IAP press release after the meeting endorsed the vaccine in spite of the unanswered questions!
If answers to these straightforward questions are not known to the health ministry, how can we push the vaccine in the rest of the country?
We need to understand that the mandate of the health services and doctors is to protect the lives of children and not to promote vaccines of doubtful utility and safety.
(10.10.2013 - Jacob Puliyel is Head of Pediatrics at St Stephens Hospital, Delhi. He is a member of the National Technical Advisory Group on immunization and has published extensively on vaccines. He can be reached at email@example.com)
- Pharmaceuticals & Drug Trials