For the 25 million infants born in India every year, it’s a matter of life and death. The controversy over the pentavalent vaccine — that promises protection against diphtheria, whooping cough, tetanus, hepatitis B and pneumonia and meningitis caused by the Haemophilus Influenzae type B (Hib) — is back in focus. Last week, following the reports of 21 deaths, the Union Ministry of Health and Family Welfare (MoHFW) was prompted into action, and announced its decision to conduct a study to investigate the issue.
In developing countries such as India, the pentavalent is being backed by the Global Alliance for Vaccination and Immunisation (GAVI) [an association of vaccine manufacturers and donors] and international agencies such as the WHO, UNICEF and World Bank. These agencies have been at the forefront of advocating for introduction of the vaccine into the Universal Immunisation Programme (UIP). But concerns about the safety and efficacy of this combination were raised much before its introduction in Kerala and Tamil Nadu in 2011.
While the vaccine has been available in the private market for over five years now, the suggestion to conduct a pilot study in Kerala and Tamil Nadu was taken in 2011 by the National Technical Advisory Group on Immunisation. Deaths had been reported in Sri Lanka, Bhutan and Pakistan, hence the pilot study before scaling it up. A PIL had also been filed by doctors, public health activists and experts questioning the safety and rationale for introducing this vaccine in the UIP in 2010 in the Delhi High Court. Yet, despite media reports of deaths in the two States, the project was scaled up to the states of Gujarat, Haryana, Karnataka, Goa, Jammu and Kashmir and Puducherry.
Around that time, a WHO report had given the vaccine a clean chit, claiming that the deaths in Sri Lanka were “unrelated” to the vaccine. But according to an editorial in the British Medical Journal , this claim was possible only because the WHO classification was changed. Since the investigation concluded that there was no alternate cause of deaths, the deaths that would’ve fallen under the “probably related” (to the vaccine) category were now put under “unrelated”. The category “probably related” was removed.
In 2011, before the vaccine was launched in Kerala, the Noel Narayanan committee was also set up in the State, and made suggestions to monitor every infant receiving the vaccination for the next 48 hours. However, this was acted upon only partially: data on Adverse Effects Following Immunization (AEFI) was recorded only for those who received the vaccine at the health centre and came back to report, leaving a serious possibility of under-reporting of the adverse effects.
Six months after the vaccine was introduced in Kerala, 40,000 children were vaccinated, five died, and the toll went up to 14 by the end of the year. An RTI filed by Kerala-based Dr. K.V. Babu shows that total deaths following vaccination in Kerala peaked in 2012 (a year after pentavalent was launched): one AEFI death was reported in the 2009, 2010, and 2011; in 2012, the number went up to 13.
While deaths in Kerala were attributed to other diseases and ‘sudden deaths’, an editorial published in July in the Indian Journal of Medical Ethics states that none of the suggested causes were sufficient reasons for the deaths. Here, the author, Dr. Jacob M. Puliyel, Head of Department of Paediatrics at St Stephen’s Hospital, also claims that in a high literacy State such as Kerala, it was “unlikely” that mothers would get sick children vaccinated.
In India, the five-in-one shot is competing against the low-cost DTP vaccine, with added protection against meningitis and pneumonia caused by Hib. However, the Indian Journal of Medical Ethics editorial states that studies have established the incidence of meningitis in India as seven per 100,000 and the mortality rate of 10 per cent. Further, it is argued that in a birth cohort of 25 million, this would mean saving 175 children, and when added to deaths caused by pneumonia, this would mean that the five-in-one shot would save 350 lives. Deaths caused by the vaccine, however, going by past trends, would be 3,125. The editorial also highlights that the vaccine has not been licensed for use in the U.S. by the Food and Drug Administration (FDA) and has recently been suspended in Vietnam after 12 deaths were reported.
The government, however, is tight-lipped about the nature of yet another study, after this saga of repeated investigations and counter-claims. “The proposed study is a large cohort study to comprehensively address events after each of the three pentavalent doses,” is all Dr. N.K. Arora, Chairman, AEFI Committee, MoHFW, is willing to reveal. The exact nature of the study, the involvement of international agencies and the new light that will shed on the unresolved debate on vaccine’s safety remains to be seen.
(The writer is a Fulbright scholar and an independent journalist)
