Dive Brief:
- Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human papillomavirus, or HPV, as well as a different regimen of the shot it currently sells.
- The trials are bids to improve upon vaccines Merck currently markets as Gardasil and Gardasil 9. One will test a shot meant to provide protection against more strains of HPV. The other will evaluate a single-dose regimen of Gardasil 9. Both studies should begin in the fourth quarter of this year.
- Gardasil is approved for use against genital warts and to prevent several cancers caused by strains of HPV. The vaccine is one of Merck’s top-selling products and still growing. It generated $8.9 billion in sales in 2023, up 29% from the previous year.
Dive Insight:
HPV is a common sexually transmitted infection that, in most cases, doesn’t lead to health problems. However, certain “high-risk” strains of the virus can cause several types of cancer, among them tumors of the cervix, mouth and throat.
Cervical cancer is a particularly high risk, with persistent HPV infections accounting for most cases, studies have shown. Those tumors are the fourth most common tumors in women globally and are more prevalent in low and middle-income countries, where there are fewer resources and medical interventions.
In recent years, evidence has accumulated showing HPV vaccination can help prevent the occurrence of cancer. A study from Scotland, published earlier this year in the Journal of the National Cancer Institute, found that the country detected no cases of cervical cancer in women born between 1988 and 1996 and who were vaccinated between the ages of 12 and 13.
But there is room for improvement. In its statement, Merck noted that scientific leaders have been calling for more data on additional dosing regimens of Gardasil, as the current three-shot schedule is one reason uptake falls short of the World Health Organization’s goals. There are also different types of HPV strains that don’t fall under the nine Merck’s shots are currently designed to target.
The new trials are designed to solve those problems.
“Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” said Eliav Barr, chief medical officer of Merck Research Laboratories, in a statement. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.”