0937 Adverse effects and HPV vaccine

In a recent summary (0929) the comment was made that Paediatricians, as advocates of child and adolescent health, should be considering HPV immunisation to prevent future cervical and other HPV-related cancers. Not long after posting this summary the media were abuzz with reports of the post-vaccination death of a 14-year old in the UK. Subsequent autopsy reports have indicated that the vaccine was not to blame, but there has nevertheless been concern about whether the prevention programme should be continued. Health authorities in the UK and US are comfortable in recommending that the programme should continue and cite the following as being of importance: safety and efficacy studies were carried out on tens of thousands of subjects before the approval and registration of bivalent and quadrivalent vaccines over the past three years. Efficacy has not only been in terms of immunity but also in terms of reductions in HPV-related genital lesions. Some 14 million doses have been administered in the UK and 26 million in the US. Potential adverse effects reported to the CDC include over 40 deaths, but follow up has failed to conclusively link the deaths to the vaccine. A meta-analysis of adverse effects suggests that syncope and thrombo-embolism require further investigation. The manufacturers of the vaccine that was linked to the UK death withdrew the batch but have not withdrawn the vaccine from the market. At this stage there does not appear to be sufficient evidence to recommend cessation of the immunisation programmes.

Read more:
Reports of health concerns following HPV vaccination:
http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm
JAMA 2009; 302: 750-7