Hepatitis B vaccine

RAPID REBUTTAL - New vaccination fears over plan to give hepatitis jabs at eight weeks old - [EK]

April 2009
Following is more rapid rebuttal of the Department of Health claims in today's UK Mail on Sunday story - New vaccination fears over plan to give hepatitis jabs at eight weeks old

If you are concerned, write to your MP or political representative - don't and you only have yourself to blame. 
 
In the light of the following you need to write to your MP or political representative and ask:-
  • what British parent should be asked to consent to this vaccination for an 8 week old baby when there are no clinical benefits to the infant - only risks
  • whether the Joint Committee on Vaccination and Immunisation can be trusted with British child health safety or whether it is reckless over vaccinations safety issues
Below are details of:
  • infant deaths and the suspensions and withdrawals  of 4 Hepatitis B vaccines [GSK's vaccine only last week in the UK] between 2000 and 2009 in the EU and UK  - with denials of connections with infant deaths and claims the vaccines are ineffective instead
  • 1999 research showing the low prevalence of hepatitis B in England and Wales, that this is are consistent with previous estimates of carriage and suggesting that many infections were acquired while resident outside the UK.
  • this all suggests Government should concentrate its efforts on effective treatment rather than vaccination of infants against a disease which does not affect them

Hepatitis B Vaccine Linked to Infant Deaths, Plus UK & EU Official Suspensions And Withdrawals

The Hepatitis B containing multiple vaccine "Hexavac" was withdrawn following unexplained infant deaths in Germany in 2005 although the European Medicines Agency denied any connection and said the withdrawal related to doubts over its effectiveness.  [See below full text

Only last Tuesday 7th April The Medicines and Healthcare Products Regulatory Agency (MHRA) instructed medical professionals to contact patients who were immunised against Hepatitis B in the last month as the vaccine is thought to be ineffective.
[See full text below: MHRA recalls GSK's Hepatitis B vaccine - Hays Pharma News]

A - Hepatitis B Vaccine Deaths and Vaccine Suspensions and Withdrawals

  • "Unexplained cases of sudden infant death shortly after hexavalent vaccination." Zinka B, Rauch E, Buettner A, Rueff F, Penning R. - Vaccine. 2005 May 18
Vaccinations are considered to be the most effective and safe method preventing infectious diseases. Although hexavalent vaccines like Hexavac((R)) and Infanrix Hexa((R)) are assumed to be well tolerated and safe regarding the rate of immunity  [Liese JG, Stojanov S, Berut F, Minini P, Harzer E, Jow S, et al. Large scale safety study of a liquid hexavalent vaccine (D-T-acP-IPV-PRP-T-HBs) administered at 2, 4, 6 and 12-14 months of age. Vaccine 2002;20:448-54; Mallet E, Fabre P, Pines E, Salomon H, Staub T, Schodel F, et al. Immunogenicity and safety of a new liquid hexavalent combines vaccine compared with separate administration of reference licensed vaccines in infants. Pediatr Infect Dis J 2000;19:1119-27], it was noticed that several cases of death occurred shortly after the vaccination. We report six cases of sudden infant death that occurred within 48h after hexavalent vaccination. At post-mortal examination, those cases showed unusual findings, especially in the brain and in laboratory tests. Crude calculations of local epidemiology are compatible with an association between hexavalent vaccination and unusual cases of sudden infant death. If confirmed in systematic studies, our findings would have potentially serious clinical implications.
  • Neonatal Deaths After Hepatitis B Vaccine - The Vaccine Adverse Event Reporting System, 1991-1998 - Arch Pediatr Adolesc Med. 1999;153:1279-1282
    • Results: Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 girls (1 patient unclassified). The mean age at vaccination for these 18 cases was 12 days(range, 1-27 days); median time from vaccination to onset of symptoms was 2 days (range, 0-20 days); and median time from symptoms to death was 0 days (range, 0-15 days). The mean birth weight of the neonates (n = 15) was 3034 g (range, 1828-4678 g). The causes of death for the 17 autopsied cases were sudden infant death syndrome for 12, infection for 3, and 1 case each of intracerebral hemorrhage, accidental suffocation, and congenital heart disease. Conclusion: Few neonatal deaths following HepB vaccination have been reported, despite the use of at least 86 million doses of pediatric vaccine given in the United States since 1991. While the limitations of passive surveillance systems do not permit definitive inference, these data suggest that HepB immunization is not causing a clear increase in neonatal deaths.
  • MHRA recalls GSK's Hepatitis B vaccine - 07 Apr 2009 - Regulatory Affairs - Hays Pharma News
     
The Medicines and Healthcare Products Regulatory Agency (MHRA) is instructing medical professionals to contact patients who were immunised against Hepatitis B in the last month as the vaccine is thought to be ineffective.

It is advising patients who received the injection, GlaxoSmithKline's (GSK's) Energix B, between March 9th and April 6th, to contact the GP or travel clinic that administered it as the batch was exposed to sub-zero temperatures during transportation.

Professor Kent Woods, chief executive of the MHRA, says: "The safety of the vaccine is not in question, but it is suspected to be ineffective."

The agency has issued a drug alert to recall the batch from the market and it is asking friends and families of people travelling abroad who may have been immunised with the vaccine to contact the clinic where it was dispensed to make sure they have not been affected.

Earlier this month, the MHRA reported that two batches of Novartis' meningitis C vaccine, which were recalled as a precaution in February, have since been found to be safe.
  • "European Medicines Agency recommends suspension of Hexavac" Press Release - 20th September 2005 
    • EMEA Press Release EMEA announces recommendation for suspension of the marketing authorisation for Hexavac - EMEA/297369/2005
  • EMEA Withdrawal of the Marketing Authorisation for the Medicinal Product Hepacare (Triple hepatitis B recombinant vaccine)EMEA/32933/02- 20/12/02
     
    • Public Statement on Hepacare (Triple hepatitis B recombinant vaccine)17/12/02 - EMEA/32933/02
  • Withdrawal of the Marketing Authorisation for the Medicinal Product Primavax (Diptheria, Tetanus, and Hepatitis B vaccine) - 04/12/00 - EMEA/H/2681/00

B     Low Prevalence in The UK of Hepatitis B and Infections acquired abroad

The prevalence of hepatitis B infection in adults in England and Wales - Epidemiology and Infection (1999), 122:133-138 Cambridge University Press
 
Cost effectiveness analyses of alternative hepatitis B vaccination programmes in England and Wales require a robust estimate of the lifetime risk of carriage. To this end, we report the prevalence of infection in 3781 anonymized individuals aged 1544 years whose sera were submitted in 1996 to 16 microbiology laboratories in England and Wales. One hundred and forty-six individuals (39%) were confirmed as anti HBc positive, including 14 chronic carriers (037%). The prevalence of infection and carriage was higher in samples collected in London and increased with age. No increased risk of infection was seen in sera from genito-urinary (GUM) clinics. Only 15 sera positive for hepatitis B were also positive for hepatitis C. Our results confirm the low prevalence of hepatitis B in England and Wales, are consistent with previous estimates of carriage and suggest that many infections were acquired while resident outside the UK. Future prevalence studies should determine the country of birth and other risk factors for each individual in order to confirm these findings.  (Accepted September 14 1998)
 
C    Examples of Some Other Risks of The Hepatitis B Vaccine
  • "Multiple sclerosis and hepatitis B vaccination: Adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence" Comenge Y; Girard M (Med Hypotheses, doi 10.1016/j.mehy.2005.08.012) (Text available in electronic form on request.)
  • "Autoimmune hazards of hepatitis B vaccine" Girard M (Autoimmun Rev 2005; 4:96-100) (Text available in electronic form on request.)
  • "Recombinant hepatitis B vaccine and the risk of multiple sclerosis - A prospective study" Hernan MA, Jick SS, Olek MJ, Jick H(Neurology 2004; 63:838-42).