Health Department officials fear that a controversy over the introduction of the pentavalent vaccine may well go on to cast a shadow on the universal immunisation programme of the State government.

Public health activists have been expressing scepticism about the “safety” of the new vaccine. They question the rationale behind introducing universal immunisation against hepatitis B and Haemophilus influenzae type B (Hib) meningitis through the vaccine.

The pentavalent vaccine, in one shot, vaccinates a child against the two diseases and diphtheria, pertussis, and tetanus (DPT). The present trivalent vaccine is good only against DPT.

As arguments over the need for the new vaccine and demands for impact studies rage, there is a sense of anxiety among health officials in Kerala, the only State apart from Tamil Nadu to be chosen by the Union Health Ministry to introduce the vaccine.

At present, in Kerala, the pentavalent vaccine is being administered only in the private sector. Thus, while a section of infants from families that can afford the vaccine are immunised against the five diseases, babies from poor families remain un-immunised against hepatitis B and Hib. “We want all children to be protected against hepatitis B and Hib and have been lobbying hard with the Centre for ages for the introduction of the pentavalent vaccine under the immunisation programme. As a State with an excellent health-sector infrastructure and vaccine delivery logistics, Kerala is better placed to introduce this vaccine,” P.K. Jameela, Additional Director of Health Services, says.

At a time when a long-standing demand of the State is becoming a reality, the arguments about the need for, and safety of, the vaccine were unnecessary, the Health Department feels.

In 2009, the National Technical Advisory Group on Immunisation (NTAGI) took the decision to roll out liquid pentavalent vaccine, already in use in several countries.

Court case

In December 2010, a group of paediatricians, policy advisers to the government, and public health activists had gone to the Delhi High Court, questioning the rationale behind the decision to introduce universal vaccination for hepatitis B and Hib as they alleged conflicting data on the burden of these diseases in the country. They questioned the safety of the pentavalent vaccine, quoting reports about the adverse effects following immunisation from Sri Lanka and Bhutan, where the vaccine has been introduced.

The NTAGI and the Health Ministry reported to the court that the World Health Organisation (WHO), which investigated the adverse effects in the two nations, had concluded that these (including the death of a few infants) were unlikely to have been caused by the pentavalent vaccine. Thus, in August 2010, the NTAGI recommended that the vaccine be introduced in two States with good immunisation coverage and good vaccine delivery systems. “The pentavalent vaccine is WHO-approved and nearly 80 per cent of the children born in private hospitals are immunised using this vaccine. Till date, we have not had a single report about any adverse effects,” Dr. Jameela says.

Public health activists are still divided over the issues surrounding the vaccine. Jacob Puliyel, a paediatrician and member of NTAGI, has been leading the voices against the vaccine and has alleged that the WHO report was “doctored.”

Jacob John, public health specialist from Christian Medical College, Vellore, has pointed out that “suspicion and beliefs, rather than evidence, are at play” and that the NTAGI “has not erred in its judgment regarding the liquid pentavalent vaccine.”

Dr. Jameela says that any vaccine, if handled carelessly, can result in adverse effects.

The State needs to monitor the adverse effects following immunisation more stringently, but to prevent the introduction of the pentavalent vaccine on the basis of technicalities will be a disservice to children, she feels.