Indian association questions plan for hepatitis B immunisation

BMJ 2006;333:621, doi:10.1136/bmj.333.7569.621-c

Ganapati Mudur

Indian Medical Association report on Hepatitis B
Indian association questions plan for hepatitis B immunisation
New Delhi
Ganapati Mudur
The Indian Medical Association has criticised a government proposal to expand universal
immunisation against the hepatitis B virus throughout India, saying that it would be “wasteful
spending” on a low priority health problem.
In a report sent to the health ministry, the association said that a systematic review of
studies indicates that the rate of chronic carriage of hepatitis B in India is 1.6% and not 4% as
projected. It has also cautioned that the proposal to immunise infants at 6, 10, and 14 weeks
would not significantly change rates of chronic carriers because most cases result from
vertical transmission (directly from mother to baby during and after pregnancy).
The report, made public by the association last week, has evoked sharp reactions from
some doctors who have said that the lower estimate of rates of chronic carriers should not
deter universal immunisation. “When an effective, inexpensive vaccine is available, it would
be unethical to deny it to the population,” said Subrat Acharya, a gastroenterologist at the All
India Institute of Medical Sciences in New Delhi.
After a pilot project to immunise infants against hepatitis B in 15 cities and 32 districts,
the health ministry has proposed to scale up the programme nationwide at an estimated
annual cost of 5bn rupees (£58m; €86m; $110m).
The lower estimate of chronic carrier rate translates into only 16 million cases instead of
40 million, the association said in its report, which follows a 10 month long consultative
process. It has also cited national cancer registry data that show that the number of deaths
from liver cancer from hepatitis B is only 5000 instead of previous estimates of more than
180 000.
“The decision to introduce the hepatitis B vaccine into universal immunisation appears to
have been taken without thought to either the disease burden or the efficacy of the 6, 10 and
14 week schedule,” said Jacob Puliyel, a paediatrician at the St Stephen’s Hospital in New
Delhi and author of the report released by the association.
“Nowhere in the world is there any study that has demonstrated the efficacy of the 6, 10,
and 14 week schedule to reduce chronic carrier rates,” Dr Puliyel said. “The results of India’s
pilot project also remained unevaluated.”
The association has said that studies from India show that vertical transmission contributes
to a significant proportion of chronic carriers in the community and favours introducing
hepatitis B vaccination at birth.
“The health ministry knows it can’t reach all children at birth, so it’s designed this
alternative schedule,” Dr Puliyel said.
However, several doctors have expressed surprise at the association’s report and have said
that its recommendations spring from “mistaken notions of the true disease burden from
hepatitis B.”
“Neither the association nor paediatricians are in any position to appreciate the true
disease burden caused by this virus,” said Vivek Saraswat, a gastroenterologist at the Sanjay
Gandhi Postgraduate Institute of Medical Sciences in Lucknow.
Doctors have argued that the primary source of hepatitis B infection in children is
horizontal transfer in and before early school. “We have no explanation yet for the mode of
transmission, but it could be injuries,” Dr Sarawat said.
But even doctors who favour universal immunisation concede that large community
studies will be needed to resolve the true prevalence of hepatitis B in India. “There will
always be sceptics,” Dr Acharya said. “But instead of arguing against universal
immunisation, they should try to suggest ways to reduce the cost of immunisation.”