With strong new evidence published this week, the PBAC has recommended the 9-valent HPV vaccine replace the current quadrivalent one
In response to a request from manufacturer Seqirus, the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that Gardasil 9 be listed on the National Immunisation Program as a two-dose schedule for females and males, aged 12-13 years as part of a school age program for the prevention of HPV, to replace the current three-dose schedule of Gardasil.
Seqirus is also the manufacturer of Gardasil, the quadrivalent HPV vaccine that has been part of the school-based immunisation program since 2007 for females, and was extended to include males in 2013.
Gardasil 9 has been found to prevent infection, cytological abnormalities, high-grade lesions, and cervical procedures related to nine types of HPV, according to new research published this week in The Lancet.
Researchers recruited over 14,000 women aged 16-26 years old for the randomised, double-blind, efficacy, immunogenicity and safety study of the 9-valent HPV vaccine study.
Funded by Merck, the research was undertaken at 105 study sites in 18 countries, and followed up over six years.
Nearly all participants (99.6-100%) in the 9vHPV vaccine group had developed antibodies at month seven, and most participants (77.5-100%) remained seropositive at the five-year mark.
A higher reduction in persistent infection and cytological abnormalities related to one type of HPV (16) was also observed in the 9-valent HPV vaccine compared with the quadrivalent vaccine.
Vaccine efficacy was found to be sustained during the follow-up period.
Seven participants experienced serious adverse events that were considered vaccine-related – four in the 9-valent group and three among the quadrivalent group.
While 11 participants died during the study follow-up period (six in the 9vHPV group and five in the qHPV group), none were considered vaccine-related.
Overall, the researchers concluded that Gardasil 9 “shows high and sustained efficacy for prevention of persistent infection and disease related to [five new HPV types: 31, 33, 45, 52 and 58] up to six years following the first vaccination visit”.
Furthermore, it also showed robust efficacy in preventing cervical cancer grade 3 or worse, abnormal cervical cytology and cervical procedures related to these HPV types.
Gardasil 9 “could potentially provide broad coverage and prevent 90% of cervical cancer cases worldwide,” the researchers conclude.
Since 2007, the National HPV Vaccination Program has been credited with dramatically reducing the incidence of the HPV virus in Australia.
Inclusion of the HPV vaccine on the National Immunisation Program makes a difference, say experts.
“To make an impact on HPV-associated disease, particularly cervical cancer, which is responsible for over a quarter of a million cancer-related deaths in developing countries, wide coverage of young women with HPV vaccination is crucial,” writes Dr Lynette Denny from the Department of Obstetrics and Gynaecology, University of Cape Town, South Africa, in an accompanying editorial in The Lancet.