A leading journal of medical ethics has charged the World Health Organization (WHO) with promoting the Pentavalent vaccine in countries, including India, though it is known to have caused adverse reactions and deaths in children.
In a hard-hitting editorial, the latest issue of the Indian Journal of Medical Ethics (IJME), has accused the WHO of promoting the vaccine "by stating falsely that no adverse event following immunisation (AEFI) has ever been reported with the vaccine".
The Pentavalent vaccine combines the Diphtheria, Pertusis, Tetanus or DPT vaccine - used in national immunisation programmes - with Hepatitis-B and H influenza-b or Hib vaccine. This combination vaccine is not licensed for use by the US Food and Drug Administration nor is it used in other developed countries, the editorial says. But WHO recommends it in developing countries.
The IJME editorial by Jacob Puliyel, head of paediatrics at St. Stephen's Hospital in New Delhi, is based on his investigation into the deaths of children in Bhutan, Sri Lanka, India and Vietnam following the use of Pentavalent vaccine.
It says on May 4, Vietnam's health ministry suspended Quinvaxem - the Pentavalent combination used in that country - after 12 deaths and nine non-fatal serious adverse events. According to local news reports, all the babies who died were in good health prior to vaccination.
WHO, which investigated the incident, said the deaths were not vaccine-related and asserted that "Quinvaxem was prequalified by WHO and no fatal adverse event following immunisation has ever been associated with this vaccine".
The editorial points out that WHO had not disputed the death of 12 children soon after immunisation and "therefore it is patently wrong and misleading for it to conclude that no fatal AEFI have ever been associated with the vaccine".
Bhutan stopped the programme following four unexplained deaths soon after immunisation but was later persuaded to restart it by WHO.
The deaths in Sri Lanka also resulted in the suspension of the immunisation drive there. A WHO committee that investigated the deaths reported that the deaths were not due to the vaccine but could find no alternate cause, the journal says.
In Pakistan - where a child died within half an hour of receiving the vaccine and two others died within 12 to 14 hours - the vaccine was not blamed but no alternate cause of death was found for any of the cases, the IJME editorial says.
In India, according to IJME, 21 children have so far died in a limited experiment with the vaccine introduced in 2011 in the immunisation programme in Tamil Nadu and Kerala. India had announced plans to roll out the vaccine to other states after monitoring its impact in these two states.
"The common factor has been that the children had received the Pentavalent vaccine and in most of them, this was followed by high fever, excessive crying and in some, there were convulsions before the child died," the editorial said.
The journal has also questioned the very rationale for introducing Hib vaccination in India, where the incidence of Hib disease is very low. The editorial estimates that vaccinating 25 million babies could at best save 350 children from Hib meningitis and Hib pneumonia but "3,125 children will die from vaccine adverse effects".
The journal warns that when countries like Bhutan and Vietnam have taken action, it is imperative that India acts to protect the lives of its children. "To trivialise all these deaths as "coincidental deaths is hiding the real picture".
(K.S. Jayaraman can be contacted at email@example.com)