Letter to Health Minister, India on Hep-B Vaccine
To,
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
Programme..
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
nil.
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?
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
Programme..
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
nil.
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?
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