08/31/2009 - Articles

HPV vaccine safety reviewed

By: Susan Aldridge, medical journalist, PhD

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The HPV (human papillomavirus) vaccine was approved by the US Food and Drug Administration in 2006.  It protects girls and women from type 6, 11, 16 and 18 HPV strains. 

Types 16 and 18 of HPV are the main cause of cervical cancer and types 6 and 11 are linked to genital warts. HPV is transmitted through sexual activity.  The recommendation is that girls aged 11 and 12 should get three shots of the vaccine while older females, who may already be sexually active, get a catch up vaccination

 

Vaccines are administered to large numbers of healthy individuals. Therefore, there are always concerns over safety – and the HPV vaccine is no exception.  Researchers at the US Center for Disease Control and Prevention now report on the post-licensing safety of the HPV vaccine.  Their data comes from the Vaccine Adverse Event Reporting System who collected 12,424 reports of adverse events following HPV vaccination from June 1 2006 to December 31 2008.  This is equivalent to 53.9 adverse reports per 100,000 doses of HPV vaccine.  Of those that included time information,  40% of adverse events occurred on the day the shot was given.  Most adverse events occurred after the first, rather than second or third, shot. 

 

And, of the HPV adverse events reports, just 722 (6.2%) were classed as serious, including 32 deaths.  The most common adverse events were fainting, dizziness and nausea.  The researchers conclude that the rate of adverse events for HPV, four years after its introduction, is what might have been expected and is similar to those for other vaccines.  Therefore, the risk benefit equation for the HPV vaccine seems to justify its widespread adoption because, after all, it promises the eventual elimination of cervical cancer.  Currently, cervical cancer rates are down in developed countries which have a screening program.  Around 80% of cases of HPV-linked cervical cancer occur in the less developed world, often inflicting premature death upon young women with children.

 

Source

Slade BC, Leidel L et al Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine Journal of the American Medical Association August 19 2009;302:750-757

Created on: 08/31/2009
Reviewed on: 08/31/2009

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