Complications caused by vaccines administered to children may never be acknowledged if the revised Adverse Effects Following Immunisation guidelines continue to remain so.
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umbai: 25 children died, 146 suffered vaccine-related side effects since 2013’ and ‘Four children die in Kerala after administration of Pentavalent vaccine’ may seem completely unrelated news reports but they are strongly linked by AEFI or Adverse Effects Related to Immunisation which is a medical complication associated with vaccines.
It does not mean vaccines are bad in nature or administered poorly. It means that vaccines, which are drugs used as a preventive measure, and given to healthy children may also have post-administration effects that need to be carefully monitored. This is where the AEFI surveillance programme which has been in place since 1988 comes into the picture. It demonstrates the country’s intent of delivering quality immunisation services with safe vaccines and ensures public confidence in the vaccines.
“The national AEFI guidelines were revised in 2005, 2010 and 2015. However, the last revision has still concerned paediatricians who are urging the World Health Organisation (WHO) to take note of the immediacy of the situation.”
The eminent paediatricians, Dr Jacob M Puliyel and Dr Pathik Naik, draw attention to the fact that out of 136 reported cases of AEFI during 2012-2016, 58 died while 78 survived hospitalisation.
“The report published in the Indian Journal of Medical Ethics further highlights that among 96 per cent of the child deaths related to vaccines, the cause was listed as ‘unclassifiable’ or ‘co-incidental due to something other than vaccine’.”
As Dr Puliyel apprises Delhi Post, “In the report, it was found that none of the cases were classified as vaccine-product related reaction.” This simply means, after vaccination, if a child is admitted to a hospital with intractable convulsions, if the child makes through, the reaction could be classified as vaccine-product related reaction, but he explains, “If the child dies, then according to the revised AEFI guidelines, it will be classified as an unclassified death or a co-incidental death which may have happened due to an underlying or emergent condition, or death by a condition caused by something other than the vaccine. The vaccine should not be blamed in such situations.”
The formal revision in the AEFI guidelines follows the incident where five deaths of children were reported from Sri Lanka, which was one of the earliest countries to introduce the pentavalent vaccine (combined diphtheria, tetanus, pertussis, Hib, and hepatitis-B vaccine) in 2008.
The vaccine was withdrawn the same year and a team of WHO experts investigating the deaths reported that they deleted the categories of ‘probable’ and ‘possible’ and instead said that the deaths were ‘unlikely’ to be related to the vaccine.
Even Vietnam withdrew the vaccine following the deaths of 12 children. WHO states on their website that ‘incomplete clinical information’ complicated the causality assessment. ‘While for some cases, additional clinical information allowed another cause of death to be identified, for other cases, there remained insufficient clinical information to allow the cause of death to be ascertained, making it impossible to rule out sudden infant death syndrome (SIDS). As peak incidence of SIDS occurs in early infancy, a close temporal relationship between SIDS and receipt of pentavalent vaccine is expected by simple chance.’
Puliyel and Naik note that the Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the pentavalent vaccine but “under the definition of causal association, these deaths would not be acknowledged as related to vaccination,” he says.
Dr Puliyel also points out that a new study in India, ‘Deaths Reported after Pentavalent Vaccine Compared with Death Reported after Diphtheria-Tetanus-Pertussis vaccine – An Exploratory Analysis’ based on Government of India data shows that the switch from DPT (diphtheria, tetanus, pertussis) to pentavalent vaccine almost doubled the deaths following vaccination. “A large number of these children deaths could have been avoided had the AEFI manual not been revised,” Dr. Puliyel says.
Dr Puliyel and his co-author of the report, Dr Naik have been trying to raise the issue with WHO for the past three years but say, they have not received any acknowledgment or reaction in the matter. Despite several attempts by Delhi Post to reach WHO for their view, there was no response.
Though Dr Puliyel tells Delhi Post that a causal link between vaccination and AEFI is often hard to prove owing to medical or circumstantial factors, “it is in the interest of children and their lives, that WHO acknowledges the vaccine product-related deaths” and goes back to words ‘possible’ and ‘probable’ in relation to deaths with respect to administering vaccines in the guideline. He also warns that vaccine manufacturers could be “reckless” with regard to such adverse reactions if the situation continues.
