A vaccine that has been banned in Bhutan, Sri Lanka and Pakistan and reportedly caused 21 deaths in Tamil Nadu and Kerala is still in use in the country.
A recent editorial published in the Indian Journal of Medical Ethics (IJME) has charged the World Health Organisation (WHO) with promoting the vaccine despite adverse reactions and bans in other countries. Still, paediatricians in Bangalore and the state’s Department of Health and Family Welfare stand by the vaccine and say: “It is safe.”
Dr Jacob M Puliyel, Head of the Paediatrics Department, St Stephen’s Hospital, Delhi, in his editorial, sought a ban on the pentavalent vaccine which provides combined immunity against diphtheria, pertussis, tetanus, Hepatitis-B and H influenza-B or Hib.
The U.S. Food and Drug Administration does not licence the vaccine and it is not used in other developed countries, the editorial says.
“But the WHO is recommending the vaccine in developing countries by combining the Hepatitis-B and Hib vaccines on the well accepted DPT,” he says citing the Global Alliance for Vaccines and Immunisation (GAVI).
Alleging that the WHO has falsely reported that there were no Adverse Events Following Immunisation (AEFI), the editorial states that the organisation had not disputed 21 deaths of babies in India from 2011 after the vaccine was administered.
“Therefore, it is patently wrong and misleading for it to conclude that no fatal AEFI have ever been associated with the vaccine,” the editorial says.
The editorial points out that a majority of deaths followed the first dose of the vaccine and ruled out a random pattern in the occurrence of these deaths in Bhutan, Sri Lanka and Vietnam too.
“While an estimated 350 children could be saved from Hib disease on immunising 25 million babies in India, 3,125 children will die due to AEFI,” Dr Puliyel writes, questioning the rationale behind introducing the vaccine when the incidence of the disease in India is so low.
The vaccine was originally to be rolled out only a year after its impact was monitored in other states. But it was rolled out less than a year since its initial launch in Karnataka under the Universal Immunisation Programme (UIP).
The Karnataka Health Department is already convinced that the vaccine is reliable and that no cases of AEFI have been reported in the state three months into the programme.
Dr Hussain Saheb M Kazi, deputy director- Immunisation, state Health Department, said that the vaccine is safe and that the programme has successfully immunised thousands of babies in the state with no reports of deaths adverse effects.
“Private hospitals are lobbying against the government because after the UIP was launched, fewer people seek this vaccine in private hospitals. This has irked them and hence the anti-pentavalent vaccine campaign,” he said.
Deaths in Sri Lanka resulted in the suspension of the immunisation drive there.
After investigation, a WHO committee reported that the deaths were not due to the vaccine. But it could find no other cause for the deaths, the editorial states and warns: “To trivialise all these deaths as ‘coincidental deaths’ is hiding the real picture.”
Dr Puliyel points out that all the children who died in these incidents received the pentavalent vaccine and suffered from high fever, excessive crying. And in some cases the kids suffered convulsions before dying.
Still, Dr Brijesh Raj Mehta, child health consultant, The United Nations Children’s Fund (UNICEF), said that the reports from Kerala might not be valid and that there is no significant difference in the prevalence of AEFI in the case of the DPT and pentavalent vaccines. “This lobby is going on for a long time. But the vaccine is safe and it is still being administered in Kerala,” he said.
Dr Jagadish Chinnappa of the Indian Academy of Paediatrics stated that the deaths should have continued in Kerala and Tamil Nadu if the vaccine was really harmful.
“But in Kerala, it was an initial set of deaths. The vaccine is still being given but no deaths were reported after that. There is no reason why this vaccine must be withdrawn,” he added.