To
Ms Anu Garg,
Health Secretary
Govt of Orissa
Orissa Secretariat
Bhubaneswar.

DT: 25.11.2008

Sub: Hep-B Vaccine to Infants in Orissa.

Madam,

This has reference to my earlier letter on the subject wherein I had enclosed a
study on the Hep-B vaccine that linked it to disability in children. I now
include a PGIMER review of existing studies on the vaccine by Dr J L Mathew
that questions the efficacy of the Hep-B vaccine.
 
The review states, "In people not previously exposed to hepatitis B,
vaccination has unclear effect on the risk of developing infection, as compared
to no vaccination. The risk of lacking protective antibody levels as well as
serious and non-serious adverse events appear comparable among recipients and
non-recipients of hepatitis B vaccine."
 
In other words the vaccine is ineffective.
 
The review cautions that, "Hepatitis B vaccination is reported to be
beneficial in some specific groups of people such as babies born to women
infected with hepatitis B, health-care workers, and people with long-standing
kidney failure."
 

There is absolutely no reason to give this vaccine indiscriminately to infants
as has become the practice now ostensibly to gear up sales of this highly
dubious vaccine.
 
Regarding mass immunisation the review mentions, "This contrasts the strategy
of universal immunisation, wherein all individuals are vaccinated, irrespective
of individual risk. Universal immunisation can be used in populations with high
prevalence of hepatitis B infection and where it is difficult to identify
individuals at highest risk (Chen 1996). This is economically and logistically
more demanding and its success also depends on vaccination compliance.
Individuals at high risk frequently refuse vaccination or fail to complete the
vaccination series (Wong 1994; Nystrom 2000)."
 
This review confirms my earlier allegation that high risk groups, towards whom
this vaccine was originally targeted, shun this vaccine.
 
The review admits, "However, no meta-analyses or systematic reviews have
addressed the issue of immunisation in persons who are not at high risk of
hepatitis B exposure or individuals in the general population whose hepatitis B
exposure status is not known."
 
This review of existing studies finds that, "This review highlights the paucity
of methodologically sound trials (trials with low risk of bias) to address the
central issue of whether or not hepatitis B vaccination protects against
hepatitis B. As is the case with many vaccine trials, most hepatitis B vaccine
trials also report limited outcomes such as antibody levels one month after
vaccination along with recording a few adverse events. It has already been
emphasised that post-vaccination antibodies are only a surrogate outcome that is
believed or expected to correlate with protective efficacy.

Our review highlights several gaps in existing knowledge about hepatitis B
vaccine. Some of these include information about serious adverse events, the
concentration of antibodies generated by vaccination, duration of protective
effect, the risk of developing infection if exposed during the vaccination
series and the nature of long-term protection afforded by vaccination. A major
missing piece is the cost-effectiveness as compared to not vaccinating a cohort
of individuals."
 
This confirms that the vaccine has been pushed in a hurry and without proper
trials forcing the reviewers to revisit them and draw their conclusions.
 
Regarding the incidence of Hep-B in India a study published in Indian Pediatrics
2007 Sep 7;44 (9):663-675 17921555 titled, "Sytematic Review and meta analysis
of Prevalence of Hepatitis B in India" states, "The true prevalence (of Hep-B)
 in non-tribal populations is 2.4% (95% CI: 2.2% - 2.7%).. True prevalence
among tribal populations is 15.9% (CI: 11.4% -20.4%). " Thus universal
immunisation with this vaccine is clearly unwarranted.
 
It will be worthwhile to find out if the doctors recommend this vaccine for
their own children and relatives. Such an investigation would complete the
picture. Investigations that have been carried out to know the immunisation
status of the wards of physicians have revealed that they are not given the OPV,
DTP, MMR, Hib amongst others.
 

I will once again request you to kindly stop giving this useless but decidely
harmful vaccine to the children of Orissa and also instruct the private
practitioners to refrain from recommending and administering it.  
 
Kindly acknowledge receipt.
 
Yours faithfully,
Jagannath Chatterjee
Plot no 1181/2146, Ratnakar Bag - 2
Tankapani Road,
Bhubaneswar - 751018
Mob: 9337102146
 
cc: All those interested in the life & health of the children of Orissa.
 
Encl:

1: Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006481. Links




Hepatitis B immunisation in persons not previously exposed to hepatitis B or
with unknown exposure status.
Mathew JL, El Dib R, Mathew PJ, Boxall EH, Brok J.

Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of
Medial Education and Research (PGIMER), Chandigarh, India, 160012.
jlmathew@...

BACKGROUND: The benefits and harms of hepatitis B vaccination in persons not
previously exposed to hepatitis B infection or with unknown exposure status have
not been established. OBJECTIVES: To assess the benefits and harms of hepatitis
B vaccination in people not previously exposed to hepatitis B infection or with
unknown exposure status. SEARCH STRATEGY: Trials were identified from The
Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central
Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS,Science
Citation Index Expanded (last search, March 2007). Additionally, we contacted
experts and vaccine manufacturers, and read through reference lists for eligible
trials. SELECTION CRITERIA: Randomised clinical trials comparing hepatitis B
vaccine versus placebo, no intervention, or another vaccine in persons not
previously exposed to hepatitis B (HBsAg negative) or with unknown exposure
status. DATA COLLECTION AND ANALYSIS:
The primary outcome was hepatitis B infection (detecting HBsAg, HBeAg, HBV DNA,
or anti-HBc). Secondary outcomes were lack of sero-protection, antibody titre,
clinical complications, adverse events, lack of compliance, and
cost-effectiveness. Dichotomous outcomes were reported as relative risk (RR)
with 95% confidence interval (CI), using intention-to-treat analysis assuming an
unfavourable event for missing data. Sensitivity analyses based on
methodological quality (risk of bias), available data analysis,
intention-to-treat analysis assuming a favourable event for missing data,
best-case scenario, and worst-case scenario were conducted. MAIN RESULTS: Twelve
trials were eligible. All had high risk of bias and reporting was inconsistent.
Hepatitis B vaccine did not show a clear effect on the risk of developing HBsAg
(RR 0.96, 95% CI 0.89 to 1.03, 4 trials, 1230 participants) and anti-HBc (RR
0.81, 95% CI 0.61 to 1.07; 4 trials, 1230 participants,
random-effects) when data were analysed using intention-to-treat analysis
assuming an unfavourable event for missing data. Analysis based on data of
available participants showed reduced risk of developing HBsAg (RR 0.12, 95% CI
0.03 to 0.44, 4 trials, 576 participants) and anti-HBc (RR 0.36, 95% CI 0.17 to
0.76, 4 trials, 576 participants, random-effects). Intention-to-treat analysis
assuming favourable outcome for missing data showed similar reduction in risk.
Hepatitis B vaccination had an unclear effect on the risk of lacking protective
antibody levels (RR 0.57, 95% CI 0.26 to 1.27, 3 trials, 1210 participants,
random-effects). Development of adverse events was sparsely reported. AUTHORS'
CONCLUSIONS: In people not previously exposed to hepatitis B, vaccination has
unclear effect on the risk of developing infection, as compared to no
vaccination. The risk of lacking protective antibody levels as well as serious
and non-serious adverse events appear
comparable among recipients and non-recipients of hepatitis B vaccine.


PMID: 18677780



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