Infanrix Hexa


Last updated Manufacturer: GlaxoSmithKline Generic name: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed) Infanrix Hexa Safety Clinical safety trials were conducted by comparing side-effects from Infanrix Hexa to that of other DTPa-containing vaccines already licences. Side-effects were reported up to 3 days following vaccination. Study investigators concluded that the side-effects reported by parents were not caused by the vaccine. The EMA says that an independent review had agreed with this conclusion and that in any case they side-effects were comparable to the already licensed vaccines. EMA information I have read about other vaccines was a lot more detailed on the safety trials conducted but it seems clear that as so often, safety was based on the vaccine being no worse than its predecessors with no real placebo group and no large-scale trial. Vaccines are considered safe to such an extent, that safety judgements are more and more based on historic assessments, where safety for the individual components is already accepted. Whether that is reasonable or not is arguable. There was certainly no indication from the EMA that they had major concerns. But then they didn’t express concerns about the very short three days follow-up either. Infanrix Hexa Efficacy Like with most vaccines, efficacy was based on studying antibody response only. Children given the vaccine showed the looked-for antibody density in almost all cases after 3 doses. There is little to add to this in itself other than to remind the reader that there was no field trial showing whether the vaccinated got ill less often than the unvaccinated. As mentioned elsewhere in this book, there is evidence that antibody counts are not enough to suggest protection but it is nonetheless generally accepted in…

This content is for VIP members only.
Log In Register