CSL Seqirus secures vaccine approval to expand HPV protection in men

Biotech News: The Therapeutic Goods Administration (TGA) has granted approval for the expanded use of GARDASIL9. This approval now extends the vaccine’s coverage to males aged 9 to 45 years. GARDASIL9, a 9-valent HPV vaccine, has been recombinantly engineered to prevent not only anal cancer but also pre-cancerous or dysplastic lesions, external genital lesions, and infections caused by nine distinct HPV types.

Previously, GARDASIL9 was approved for males aged 9 to 26 years. This extension of the age indication aligns it with the approved age range for females, offering a vital preventative option for previously unvaccinated individuals who may be at heightened risk of HPV-related diseases and cancers, regardless of gender.

HPV-related diseases and cancers are often associated with cervical cancer, but it’s important to note that males are not immune to their impact. In fact, over 80% of anal cancers and 90% of genital warts in Australia can be attributed to the nine HPV genotypes covered by GARDASIL9. Furthermore, anal cancer incidence has more than doubled in the last four decades, with a more rapid increase among males than females.

Despite the success of Australia’s funded HPV vaccination program in reducing genital warts among younger individuals, the decline has not been mirrored in older males and men who have sex with men (MSM). MSM, in particular, face up to a 20-fold higher likelihood of developing anal cancer and 2–3 times greater susceptibility to genital warts compared to heterosexual males.

Professor Andrew Grulich, Medical Epidemiologist and Public Health Physician at the Kirby Institute, UNSW, emphasised the importance of HPV vaccination for males, stating, “While much attention has been given to HPV vaccination in females and the goal of eliminating cervical cancer, we must not overlook the significant health risks that HPV infection poses for males. HPV vaccination for males is crucial not only to prevent transmission to females but also to lower the risk of HPV-related diseases in males themselves, such as anal cancer and genital warts.”

He further pointed out, “The inclusion of adolescent boys in the school-based HPV vaccination program since 2013 means that there are now Australian men aged over 25 who may have missed out on HPV vaccination. While vaccination cannot clear a past infection, it can provide protection against future infections, particularly benefiting older males at higher risk of HPV-related diseases, such as MSM and people living with HIV.”

Dr Jonathan Anderson, Executive Medical Director of International Regions at CSL Seqirus, highlighted the role of community-based healthcare professionals in this extended age indication. He stated, “When we think of HPV vaccination, we often think of the school-based program. However, despite best efforts, up to one in five adolescents and young adults may have missed out on HPV vaccination at school.”

Dr Anderson added “This indication extension underscores the pivotal role that general practitioners (GPs) and pharmacists can play in safeguarding individuals from HPV infection, irrespective of their gender. This is especially critical for men at increased risk of HPV-related anal cancer, as there is currently no national screening program for early detection of this disease.”

Notably, GPs, sexual health clinicians, and, in certain states, pharmacists, are now authorised to provide HPV immunisation to males aged 26 and older through private prescriptions.

This expanded indication arrives just ahead of the Australasian Sexual & Reproductive Health Conference 2023, scheduled for September 18 – 20. CSL Seqirus will host a satellite symposium during the event, shedding light on HPV epidemiology, related diseases, recent changes to the HPV vaccination schedule, and the opportunity to enhance immunisation coverage for improved public health outcomes.

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