Usefulness of Hepatitis B Vaccine Questioned – the vaccination did not reduce hepatitis B carrier rate – defeating the primary aim of the immunization programme

An Editorial in Indian Pediatrics the journal of the Indian Academy of Pediatrics has again raised doubts about the usefulness of Hepatitis-B vaccination in India.  The full article can be downloaded here: Utility of Hepatitis B Vaccination in India Pediatrician’s Perspective

Results of the pilot study launched in Andhra Pradesh to evaluate the usefulness of the vaccine have been published in the latest issue of Indian Pediatrics.

In an accompanying editorial Rajeev Kumar and Jacob Puliyel of the Department of Paediatrics at St. Stephens Hospital say the results are clear evidence that the vaccine has not been very useful:

If the findings of this study are replicated in other areas, it should prompt a re-evaluation of the need for this vaccine in the immunization programme of the country” the editorial says.  

Twelve years ago the Global Alliance on Vaccines and Immunization (GAVI) provided India with Rs.271.9 million to study Hepatitis B vaccination in India. No study of efficacy was undertaken and universal immunization was introduced in a phased manner.

Hepatitis B spreads like AIDS from mother to child or from person to person through contaminated needles or sexual contact. However unlike AIDS, the majority of those who get infected with Hepatitis B clear the organism from their bodies. A few however do not clear the virus and become chronic carriers. Some chronic carriers develop liver cancers or cirrhosis of the liver, 40 years later. Vaccination is meant to reduce the numbers who become chronic carriers and long term problems.

The pilot study in rural Andhra Pradesh looked at over 2500 children who were given the vaccine against a similar number who had not received the vaccine and used as control group.

The study found that the incidence of chronic carriers was similar, regardless of vaccination status or, in other words,

the vaccination did not reduce hepatitis B carrier rate,” defeating the primary aim of the immunization programme, the editorial says.

Protective levels of antibodies fell rapidly among the vaccinated and by 11 years only 13% were protected. On the other hand among those not vaccinated, 33% had developed natural immunity by 6 years of age.

Kumar and Puliyel note that Hepatitis-B vaccine in now being given as Pentavalent vaccine in combination with DPT and Hib (Haemophilus influenzae type B) vaccines. They say that:

the efficacy of Hepatitis-B vaccine when given mixed with other vaccines “is likely to be even lower than what was reported in the study that was conducted with Hepatitis-B as a stand-alone vaccine.”

The editorial also notes that with introduction of Pentavalent vaccine, immunization uptake has fallen dramatically – perhaps related to sporadic reports of deaths with the vaccine. According to the 4th District Level Household Survey (DLHS-4: 2012-13), the numbers of the fully immunized in states with good coverage in the past, like Tamil Nadu, fell by as much as 25% in 4 years to a mere 56%.

This would further reduce the benefits in field-condition from the Hepatitis B vaccination programme,” Kumar and Puliyel point out.

According to the editorial, the findings of the pilot study support the contention that Hepatitis B is widespread but it is a benign disease in India possibly because of characteristics of the circulating virus strain and the genetic makeup of the population. The editorial concludes that need for this vaccine in the immunization programme should be reconsidered if the findings are replicated in other areas in India.