Accusing the World Health Organisation (WHO) of promoting pentavalent vaccine "by stating falsely that no adverse event following immunisation (AEFI) has ever been reported with the vaccine," a leading science magazine in India 'The Indian Journal of Medical Ethics' (IJME) has sought immediate ban on pentavalent vaccine in the country.

Stating that this is contrary to the facts, the IJME editorial by Jacob Puliyel, head of paediatrics at St Stephens Hospital in New Delhi, charged the WHO with promoting a vaccine whose use has been discontinued in some countries following adverse reactions and deaths in children. The IJME editorial is based on his detailed investigation into the deaths of children in Bhutan, Sri Lanka, India and Vietnam following administration of pentavalent vaccine.

The pentavalent vaccine combines the diphtheria, pertusis, tetanus or DPT vaccine-- long used in national immunization programmes--with Hepatitis-B and H influenza-b or Hib vaccine.

On May 4, 2013, the Ministry of Health of Vietnam suspended Quinvaxem- the pentavalent combination used in that country -- after 12 deaths and nine other non-fatal serious adverse events. According to local news reports, all the babies who died were in good health prior to vaccination and had serious trouble breathing before dying shortly afterwards.

The 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 immunization has ever been associated with this vaccine.”

The editorial points out that WHO had not disputed the death of 12 children soon after immunization and therefore it is patently wrong and misleading for it to conclude that no fatal AEFI have ever been associated with the vaccine.

Bhutan, Sri Lanka and Pakistan have also stopped using the vaccine following unexplained deaths soon after immunization, the IJME editorial says.

Bhutan stopped the immunization programme after four deaths but was later persuaded to restart immunization by WHO. Reintroduction of the vaccine was followed by a further four deaths and Bhutan is not using this vaccine any longer, the journal says. The deaths in Sri Lanka also resulted in the suspension of the immunization 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 for the deaths.

In Pakistan too -- where one 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 article says.

It further says that this combination vaccine is not licensed for use by the US FDA nor is it used in other developed countries, the editorial says. But the WHO recommends this pentavalent vaccine in developing countries, by piggy backing the hepatitis-B and Hib vaccines on the well accepted DPT to increase uptake of hepatitis B and Hib according to a write up on the GAVI website.

In India, according to IJME, 21 have so far died in a limited experiment after the vaccine introduced in 2011 in the immunization programme of 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 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 "3125 children will die from vaccine adverse effects."