MSD eyes new public health approaches after HPV vaccine's expanded approval

Biopharma giant MSD says it stands ready to pursue new approaches to advance public health in China after its GARDASIL vaccine received expanded approval for males, the first such indication in the country.

Anna Van Acker, senior vice president of MSD and president of MSD in China, said she feels the excitement from the new approval which marks a significant step in improving public health for both men and women.

The Human Papillomavirus is a common cause for cervical cancer in women. But it also increases the risk of genital warts and several types of cancers among men.

In 2017, MSD gained approval for GARDASIL in China, followed by GARDASIL 9, and also the expansion of the indications over the next few years. "Since then we have protected more than 50 million women and girls," said Van Acker.

As of January 2025, Gardasil 9 is the only nine-valent HPV vaccine that meets the four WHO evaluation standards including immunogenicity, effectiveness, efficacy and safety.

Its effectiveness evidence covers the entire course of cervical cancer and can provide full protection and it’s the only nine-valent HPV vaccine that has achieved the gold standard for effectiveness in clinical trials.

The nine-valent HPV vaccine (derived from saccharomyces cerevisiae) has shown good safety in real-world monitoring after its launch in China and abroad. By the end of 2024, nearly 300 million doses of Gardasil 9 has been administered worldwide.

The nine-valent HPV vaccine has sufficient clinical research evidence and has also been verified by real-world vaccination for nearly 10 years and several domestic HPV vaccines are using the nine-valent HPV vaccine (derived from saccharomyces cerevisiae) as a control vaccine.

In an interview in Shanghai earlier this month, she also highlighted the urgency following the the National Medical Products Administration (NMPA)'s approval of the vaccine for males in China.

"It's a very efficient and safe way to make sure now that we don't only protect females, but also males. The new indication is the first of its kind in China, and we feel very excited about that."

Cervical cancer is the fourth most common form of tumor among women worldwide, with the disease claiming the lives of almost 350,000 women in 2022, according to the World Health Organization.

And thousands of men and women also die every year of other HPV- associated cancers, including those of the anus, vulva, vagina, penis and oropharynx.

In May 2018, WHO Director-General Dr Tedros Adhanom Ghebreyesus announced a global call for action to eliminate cervical cancer, underscoring renewed political will to make elimination a reality and calling for all stakeholders to unite behind this common goal.

The International Papillomavirus Society (IPVS) also released a call for action to health authorities to adhere to international standards established by the WHO and to develop national, regional and local plans to ultimately achieve the goal of cervical cancer elimination as a public health problem.

The IPVS also urges national regulatory authorities in countries where HPV vaccination is not currently available to make it accessible to girls and women as soon as possible and to strongly consider vaccination for males as well.

Cervical cancer is one of the few cancers that is almost totally preventable. The HPV vaccine is among one of the few cancer preventing vaccines which has proven effective against most HPV strains, more than 70 percent of cervical cancer cases are caused by these strains.

Medical experts have been calling for wider coverage of the vaccination as a crucial part of gynecological disease prevention and control.

Vaccination is also the key measure for a nationwide 2030 blueprint by China to promote cervical cancer prevention and treatment.

"With the new indication for males, we now have a broader approach to look at how we can protect families, communities and society as a whole, and to contribute to public health," Van Acker said.

MSD is seeking new approaches so that more efforts can be put into triggering more awareness around males. "For us gender neutral vaccination is certainly a big topic and we aim to bring together stakeholders in the ecosystem, our partners, but also experts, and health care professionals for this cause."

It would be beneficial for the overall public health for males to grow a sense of relevancy and conscious and also take action, she noted.

Van Acker said it's a matter of public health security in general, stressing that the importance to learn about HPV vaccination is equal for both genders.

"HPV does not know any gender so it's important to build comprehensive knowledge around the topic for the whole of society.

"We're only at the beginning to trigger public awareness and to carry out a public health campaign with the same rigor and the same level of activity, and at the same time we also hope to encourage and mobilize females to encourage males."

Van Acker also hopes for a significant spillover in terms of how females can become a powerful force of persuasion and encouragement for men to take action.

MSD will continue research and development and to find innovative ways of preventing HPV-related infections and diseases. "We stand ready to continue to drive innovation and to step up," she added.

"This newly-approved indication creates more possibilities for the future and we hope to leverage the extensive data around 4-Valent and 9-Valent HPV vaccines. We will go on investing in clinical trials — real world evidence — so we can continue to deliver a very effective and a very safe vaccine."

At the same time "Writing Our Future Plus" is MSD's strategy and it has proposed that each and every individual should write their future based on good health and do more about health, which is a critical piece of everyone's future.

Van Acker also believes that the different approaches and the more angles the company can take, the better it can get to some of those great goals and to ultimately achieve the prevention, elimination of cervical cancer and the removal of HPV-related cancers from the world.

MSD also welcomes other players to offer vaccination and engage in preventing cervical cancer, she added. "We aspire to be a trusted leading partner in the China health care ecosystem, and one of the pillars of our strategy is a holistic approach that covers prevention, treatment and ultimately cure."