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11 years of HPV vaccine surveillance affirms safety

A new large-scale study analysing surveillance data over 11 years has affirmed the safety of quadrivalent human papillomavirus (4vHPV) vaccine among both boys and girls. Australia has been a world leader in showing the impact of the comprehensive, fully funded National Immunisation Program for the prevention of HPV-related diseases, particularly cervical and other cancers. The program was introduced for girls in 2007 and extended to boys in 2013.

The study, led by authors from the National Centre for Immunisation Research and Surveillance (NCIRS) and the University of Sydney, and published in the journal Vaccine, examined all adverse events following immunisation with 4vHPV vaccine reported to the Therapeutic Goods Administration (TGA) from 2007 to 2017. The study included detailed examination of data from 2 years of enhanced surveillance, which was implemented when 4vHPV vaccine was first introduced for boys in 2013.

The analysis did not reveal any new or concerning safety issues. Syncope (fainting), a well-recognised stress-related reaction to vaccination, was the most common of the specific adverse events examined in the study. The study found that syncope following vaccination was more common among younger (12- to 13-year-old boys and girls) than older (14- to 15-year-old boys) adolescents.

“This study highlights the possibility of syncope in younger adolescents and the need for immunisation providers to prevent syncope-related injury from falls,” said Dr Anastasia Phillips, lead author and public health physician. “For example, the patient can sit down or lie down when they receive a vaccination and they should also be observed afterwards,” she said.

This analysis has not only provided valuable information affirming the safety of 4vHPV vaccine, but also highlights the value and robustness of Australia’s vaccine adverse events reporting system which includes systems within each state and territory and direct reporting feeding into the TGA’s national database. In addition, Australia has other active surveillance mechanisms, including public surveys of adverse events following immunisation via AusVaxSafety.

Read the full study here