In less than three years, 26 absolutely healthy babies died in seven different places across the country soon after receiving the measles vaccine. The government, instead of coming up with stringent measures to track Adverse Events Following Immunisation (AEFI), has prepared a draft national vaccine policy that attempts to tamper with the system used worldwide to examine such adverse events. Moreover, till today no enquiry reports into the deaths after immunization has been made public, not even reports of the 2008 deaths that happened as far back as 2008.
Vaccines, administered on a large scale to healthy individuals (healthy babies in this case), demand a very high degree of safety, states the WHO publication on immunisation safety adding that monitoring immunisation safety is an essential part of every immunisation programme.
In India, forget about just minor adverse reaction, healthy children have been dying soon after immunisation and the number of such deaths has increased hugely from six deaths in 2002, and 13 in 2003 to 111 in 2008 and 116 deaths in 2009. The ministry attributes it to better reporting and surveillance. That seems hard to believe since four infants dying after vaccination would be widely reported at any time, surveillance or not.
Interestingly, the draft vaccine policy presented to the Delhi High Court indicates an attempt to whitewash all vaccine deaths in the future, unless it can be proved that the vaccine was contaminated or unless the number of deaths changes the baseline demography data in the region (meaning huge number of deaths are needed before the government will take cognizance.)
The draft vaccine policy, after referring to the Brighton classification system (the one recommended by WHO) for examining adverse effects following immunisation, states that “establishing/dissociating a causal link between the event and immunisation should be established based on laboratory findings and baseline demography data from the region”. The Brighton classification does not depend on laboratory findings or demography data from the region.
The WHO when contacted, expressed support for the Brighton classification system as also evident in its document on standard AEFI classification which states: “Standardized case definitions for some AEFIs are available from the Brighton Collaboration. Use of these definitions is encouraged, especially for serious cases where systematic standardized causality assessment is required.”
The vaccine policy draft states that the AEFI guidelines were “improved” by the health ministry in consultation with the WHO. However, in the WHO’s standard system there is no reference to laboratory findings nor the practice of saying a death is unrelated if no impurities are found in the vaccine, a common practice here, nor does it talk of comparing the deaths with demography data from the region. Yet, the WHO told the TOI that causality assessment should also be based on available clinical, laboratory and autopsy findings for each case, epidemiological factors and so on.
“The government of India is trying to water down the system used across the world to examine deaths related to immunisation. In perpetual denial, the government has been unable to put an end to such recurring incidents of healthy children dying soon after injections supposedly meant to save them,” said Dr Gopal Dabade of the All India Drug Action Network.
Even if the government or the WHO claim there was no vaccine contamination or blame the health personnel for procedural errors in vaccination or claim death was due to some other cause, the fact remains that healthy children are dying in a strikingly similar manner immediately after vaccination in totally different settings and locations year after year.
“What’s common to these deaths is their incidence immediately after immunization. Instead of trying to cover up, perhaps, the government ought to conduct proper enquiries, identify and face up to the real problem in the immunisation programme and fix it to prevent any more deaths,” added Dr Dabade.
He said that the report of the government’s investigations into four deaths in Lucknow dring a mass immunisation campaign of the government, which was reported in some sections of the press as being due to the pentavalent vaccine, has still not been published. Details of which vaccines were responsible and who the manufacturers were are crucial. The Delhi High Court is hearing a petition by Dr Dabade and others pointing out that pentavalent vaccine has caused deaths in Sri Lanka, Bhutan and Pakistan. It is proposed that the vaccine must be introduced in India.
State-wise death of infants given measles vaccine
Number of reported infant deaths after immunisation since 2001
Vaccines, administered on a large scale to healthy individuals (healthy babies in this case), demand a very high degree of safety, states the WHO publication on immunisation safety adding that monitoring immunisation safety is an essential part of every immunisation programme.
In India, forget about just minor adverse reaction, healthy children have been dying soon after immunisation and the number of such deaths has increased hugely from six deaths in 2002, and 13 in 2003 to 111 in 2008 and 116 deaths in 2009. The ministry attributes it to better reporting and surveillance. That seems hard to believe since four infants dying after vaccination would be widely reported at any time, surveillance or not.
Interestingly, the draft vaccine policy presented to the Delhi High Court indicates an attempt to whitewash all vaccine deaths in the future, unless it can be proved that the vaccine was contaminated or unless the number of deaths changes the baseline demography data in the region (meaning huge number of deaths are needed before the government will take cognizance.)
The draft vaccine policy, after referring to the Brighton classification system (the one recommended by WHO) for examining adverse effects following immunisation, states that “establishing/dissociating a causal link between the event and immunisation should be established based on laboratory findings and baseline demography data from the region”. The Brighton classification does not depend on laboratory findings or demography data from the region.
The WHO when contacted, expressed support for the Brighton classification system as also evident in its document on standard AEFI classification which states: “Standardized case definitions for some AEFIs are available from the Brighton Collaboration. Use of these definitions is encouraged, especially for serious cases where systematic standardized causality assessment is required.”
The vaccine policy draft states that the AEFI guidelines were “improved” by the health ministry in consultation with the WHO. However, in the WHO’s standard system there is no reference to laboratory findings nor the practice of saying a death is unrelated if no impurities are found in the vaccine, a common practice here, nor does it talk of comparing the deaths with demography data from the region. Yet, the WHO told the TOI that causality assessment should also be based on available clinical, laboratory and autopsy findings for each case, epidemiological factors and so on.
“The government of India is trying to water down the system used across the world to examine deaths related to immunisation. In perpetual denial, the government has been unable to put an end to such recurring incidents of healthy children dying soon after injections supposedly meant to save them,” said Dr Gopal Dabade of the All India Drug Action Network.
Even if the government or the WHO claim there was no vaccine contamination or blame the health personnel for procedural errors in vaccination or claim death was due to some other cause, the fact remains that healthy children are dying in a strikingly similar manner immediately after vaccination in totally different settings and locations year after year.
“What’s common to these deaths is their incidence immediately after immunization. Instead of trying to cover up, perhaps, the government ought to conduct proper enquiries, identify and face up to the real problem in the immunisation programme and fix it to prevent any more deaths,” added Dr Dabade.
He said that the report of the government’s investigations into four deaths in Lucknow dring a mass immunisation campaign of the government, which was reported in some sections of the press as being due to the pentavalent vaccine, has still not been published. Details of which vaccines were responsible and who the manufacturers were are crucial. The Delhi High Court is hearing a petition by Dr Dabade and others pointing out that pentavalent vaccine has caused deaths in Sri Lanka, Bhutan and Pakistan. It is proposed that the vaccine must be introduced in India.
State-wise death of infants given measles vaccine
| State | Date | Babies dead |
| Tamil Nadu | 23-Apr-08 | 4 |
| Maharashtra | 28-Sep-08 | 4 |
| Assam | 22-Oct-08 | 4 |
| Uttar Pradesh | 21-Aug-10 | 4 |
| Uttar Pradesh | 15-Sep-10 | 2 |
| Madhya Pradesh | 12-Mar-10 | 4 |
| Gujrat | 16-Mar-11 | 4 |
Number of reported infant deaths after immunisation since 2001
| Year | Reported AEFI deaths |
| 2001 | 0 |
| 2002 | 6 |
| 2003 | 13 |
| 2004 | 23 |
| 2005 | 18 |
| 2006 | 54 |
| 2007 | 32 |
| 2008 | 111 |
| 2009 | 116 |
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