RAPID REBUTTAL - New vaccination fears over plan to give hepatitis jabs at eight weeks old - [EK]April 2009
The Hepatitis B containing multiple vaccine "Hexavac" was withdrawn following unexplained infant deaths in Germany in 2005 although the European Medicines Agency denied any connection and said the withdrawal related to doubts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]
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.
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.
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 15–44 years whose sera were submitted in 1996 to 16 microbiology laboratories in England and Wales. One hundred and forty-six individuals (3·9%) were confirmed as anti HBc positive, including 14 chronic carriers (0·37%). 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)