Gardasil®: A global solution to eradicating cervical cancer

From its origins in groundbreaking research at The University of Queensland (UQ), to its use in more than 145 countries worldwide, the Gardasil^® cervical cancer vaccine has led to an approximate 90 per cent decrease in the prevalence of human papillomavirus (HPV), the major cause of cervical cancer.

Four out of five people are believed to have been exposed to HPV, which is proven to cause genital warts and cervical cancer, and is linked to the development of cancers of the anus, penis, mouth and throat. Cervical cancer is one of the leading causes of cancer deaths among women in low-income countries, according to the World Health Organization.

The Discovery

The Gardasil^® story began in 1990 when molecular virologist Dr Jian Zhou joined Professor Ian Frazer at UQ to tackle the problem of developing a vaccine for HPV.

Together, they used technology to make virus-like particles that mimic HPV.

Virus-like particles structurally resemble viruses but are non-infectious because they do not contain any viral genetic material.

The Gardasil^® vaccine works by introducing virus-like particles into the body, activating the immune response, resulting in protection against future infection from HPV.

Commercialisation

UniQuest filed the initial patent applications for the HPV vaccine technology in 1991, and research continued at UQ. In 1994, UniQuest licensed the intellectual property to CSL Limited in Melbourne, Australia, with the goal of CSL developing the vaccine clinically. CSL funded further research and development and continued to involve Professor Frazer in the HPV vaccine development.

In 1996, CSL sub-licensed the HPV technology to Merck & Co., Inc. (known as Merck Sharp & Dohme outside the US and Canada), retaining the rights to market the technology in Australia and New Zealand.

In 2005, CSL entered into a cross-licensing and settlement agreement with GlaxoSmithKline (GSK) for its cervical cancer vaccine product, Cervarix^®, which also used the UQ technology.

Merck & Co., one of the largest pharmaceutical companies in the world, was an ideal commercialisation partner for the long and large human clinical trials required for the vaccine to be approved for humans.

Phase III clinical trials commenced in 2005, and involved more than 12,000 women aged 16–26, across 13 countries. The results of the trials showed women in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than those in the placebo group.

The clinical evidence was so strong that, before the study was completed, it was halted on ethical grounds to enable the young women on placebo to receive Gardasil^®.

The Federal Drug Administration (FDA) in the United States approved Gardasil® in 2006 and it was launched on the global market.

In 2014 the FDA approved Gardasil^®9 for use in males and females aged nine 26 years.

In 2018 Gardasil^®9 received approval in China and for expansion in the US to males and females aged 27-45 years.

The impact

The efficacy of the HPV vaccine is astonishingly high. In girls and young women aged nine to 26, the vaccines have been proven to protect against two types of HPV that cause about 70 per cent of cervical cancer cases, and two more types that cause about 90 per cent of genital warts cases.

Gardasil^®9 – now protects against as many as nine strains of the disease, showing its continued development and progression.

The vaccine was initially made available at a low cost to several developing nations where cervical cancer has the greatest mortality rate. Gardasil^® is now available in 150 countries and more than 270 million doses have been distributed around the world.

Through the implementation of the Gardasil^® vaccine, cervical cancer is set to become a rare disease by 2022 and so uncommon by 2035, that Australia is hopeful of becoming the first country in the world to eliminate the disease.