Sunday, November 16, 2014

Letter to Health Minister, India on Hep-B Vaccine


 The Minister
 Ministry of Health & Family Welfare
 Government of India
 Nirman Bhavan
 New Delhi-110011

Dear Dr. Ramadoss,Through the news in the Times of India (6th September) *‘**Hepatitis-B
threat bigger than AIDS’* we came to know about the decision of the
health ministry to launch the programme throught India to give hepatitis B
vaccine to all newborns by including it in the National Immunization

  This decision seems to be based on the impression that “hepatitis B is a
  bigger problem than AIDS” and the news says “Ministry records also say
  that one in every 20 people in India is a carrier of this deadly virus”. As
  socially concerned experts working in the field of Public Health, and
  Rational Drug Policy in India, we would like to point out the following – 1) The claim that 4.7% of the Indian population is chronically
 infected with hep.B virus is gross overestimation based on a paper, which
 has surprisingly made an elementary arithmetical mistake and also has
 unscientifically assumed that all those who are found to be positive for
 hep.B infection are chronic carriers of this infection. Using the same data
 correctly the actual ‘hep.B carrier rate’ works out to be only 1.42%.
 *(1)* The WHO has recommended hep-B vaccination of all newborns only for
countries where this carrier rate is more than 2%. *(2).* 2) Hepatitis B is much more infectious than HIV. However, whereas
 untreated HIV infection is 100% fatal, in case of Hepatitis B infection
 only 10% of infected adults become chronic carriers and the average
 fatality rate due to Hepato Cellular Carcinoma is much lower than what has
 been claimed *(3)*. About 90% of infected infants become carriers. But
 carriers eliminate the hep B infection at an annual rate of up to 2% *(4)*
 and the overall incidence of the damage due to hep B infection -acute
 hepatitis, chronic persistent hepatitis (CPH), chronic active hepatitis
 (CAH), cirrhosis and hepato-cellular carcinoma (HCC) is much less than what
 is generally believed. *(5)* 3) Newborns who get hep.B infection at birth from their hepB
 positive mothers have the highest risk of getting HBeAg infection which the
 most infectious variety of hep.B infection and which has the highest
 chances of becoming carriers. *(6,7)* Prevention of this perinatal
 (vertical) transmission from hepatitis-B positive mothers requires that
 newborns at risk be given the first dose of the vaccine within 12 hours of
 birth. *(8)* Hence the WHO, the American Academy of Pediatrics have
 recommended that for such newborns, the first dose of hep.B vaccine must be
 given not later than 48 hours after birth. In India, since 77% births take
 place at home, the first dose of hep.B vaccine would not be given
 immediately after birth but 6 weeks after birth with the first dose of the
 triple vaccine in the National Programme. Hence in this programme *77%
 of the newborns will not be protected from the mother- to-child mode of
 infection, which is the most dangerous type of infection. *

 4) If we want to take up Hepatitis B vaccination programme at all
 then the *Selective* *Vaccination* Strategy should be used like in other
 low prevalence countries like Japan, U.K. Netherlands. The Selective
 Vaccination strategy which consists of identifying the HBsAg positive
 mothers through antenatal screening and vaccinating their newborns within
 24 hours of birth. In India 2-3 % of mothers are hep.B positive, and this
 selective strategy would protect about 40% of the newborns from the risk of
 HBeAg positivity by vaccinating only the 3% of the newborns, and this
 programme would cost one fourth of the Universal Strategy.*(9)* The
 cost-efficacy of HB Vaccination should be measured in terms of cost per
 highly infectious carriers (HBeAg positive) prevented and not HBsAg
 positive carriers prevented. This is because as mentined above, HBeAg
 positive carriers are far more dangerous to public health, as they are far
 more infectious and are far more likely to develop serious chronic liver
 disease later than mere HBsAg positives. In India, only 65% of women get
 any health-care during pregnancy. This highly cost-effective selective
 vaccination programme will not be very effective even for control of Hep.
 B. infection, (leave aside, it's eradication from India) unless this
 coverage is substantially improved. Secondly, it will not eradicate hep B
 infection. But any way even if all newborns are vaccinated in the Universal
 Vaccination Programme, it will take at least 65 years to eradicate
 hepatitis-B infection in India.

 5) With 25 million babies being born every year in India, even
  assuming that the cost of hepB vaccine per child in this programme to be
  only Rs. 50/, (i. e. much less than the current price), it would cost Rs.
  125 crores annually for the vaccine alone. This is equal to our budget for
  TB-control programme (the number one killer of Indian adults) and is almost
  equal to the combined cost of other 6 vaccines given to infants. The
  cost-efficacy of this programme is also unfavourable - about Rs. 700 per
  life year saved *(10)* compared to around Rs. 20 per life year saved for
  the measles vaccination. *(11)*

  6) Those medical professionals who come in close contact with
  blood, patients in need of dialysis/ repeated blood transfusion and persons
  exposed to unsafe sexual relations should be vaccinated against hep.B on a
  priority along with newborns of hepatitis positive mothers. Giving this
  vaccine to all newborns, that too 6 weeks after birth, is neither effective
  in preventing the most dangerous, mother-to- child transmission nor is it
  good economics. It will primarily benefit the manufacturers of this vaccine
  who have succeeded in convincing a section of the medical professionals
  through their usual techniques.

  In view of the very serious, substantial issues mentioned above, we
  request you to stall your decision to include the hepatitis B vaccination
  in the National immunization Programme, invite us for a detailed discussion
  with the concerned officials/experts in your Ministry and initiate a public
  debate on this issue before taking a final decision.

  Sincerely Yours,
 (A doctors forum in india)
A very senior doctor comments on the recent article on the ToI criticizing the Hep-B vaccination driveA convincing article. I, personally, was opposed to the idea of mass
 immunization against hepatitisB on theoretical grounds. a0 it is
 transmitted through blood contamination. Earlier, it was emphasised that
 those connected with professions where they come in contact with human
 blood must be immunised. So, technicians and nurses were the main groups
 for whom immunization was advocated. Next, the doctors and other hospital
 ward staff.Why should ALL CHILDREN be immunised? Transmission through
 injection needles RE-USED was blamed. ( the virus is not killed even at
 100degrees C. it needs 122 degrees minimum to be killed) But now, when
 needles are not re-used, the spread by this route should be theoretically
 On the other hand, when all children are immunised by vaccination,we
 are actually introducing the virus inEVERY CHILD,. It is possible that some
 would now become chronic carriers.; the total number of carriers actually
 will be MORE not less.
 incidentally, in 50s and 60s, post operative jaundice --it was called
 Serum hepatitis-was quite common after blood transfusions but was
 considered INNOCUOUS-- mild, seif controlled and no long term effects. The
 scene changed dramatically after it was connected to developement of
 cancer.-based on foreign western statistics?

No comments: