For Health Secy, Orissa - Stop Hep-B vaccine.

[Guest guest]

ToMs Anu Garg,Health SecretaryGovt of OrissaOrissa SecretariatBhubaneswar.DT: 25.11.2008Sub: 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- 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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