WHO Endorses a New Single-Dose HPV Vaccine
- by Amber Baker
- Published
- Vaccines
The World Health Organization (WHO) announced on Oct. 4, 2024 that it has prequalified its fifth human papillomavirus (HPV) vaccine, Cecolin. Cecolin is the only vaccine approved for a single-dose regimen, setting it apart from multi-dose HPV vaccine options like Merck’s Gardasil vaccine, which typically requires three doses, and Walrinvax vaccine, which is manufactured by the Chinese biotechnology company Walvax and is given in two-doses. This announcement builds on the WHO’s 2022 guidance recommending off-label single-dose use of HPV products to support broader global immunization efforts.1
HPV is a group of more than 200 related viruses, many of which are transmitted through sexual contact. While some strains are classified as high-risk types that can lead to cancers such as cervical, anal, oropharyngeal, and genital cancers, for most healthy people, HPV infections do not become chronic and resolve on their own without any intervention or treatment. In fact, studies show that about 90-95 percent of HPV infections resolve within 1-2 years as the immune system naturally clears the virus.2
WHO officials have stated that they have set the goal of administering HPV vaccine to 90 percent of girls globally before they reach 15 years of age. In 2024, HPV vaccine coverage for girls aged 9-14 rose to 27 percent, up from 13 percent in 2023. While still significantly below the 90 percent target date set for 2030, many medical professionals say they are optimistic that the introduction of a single-dose regimen will accelerate progress toward achieving this goal.
“Having 90 percent of girls fully vaccinated with the HPV vaccine by 15 years of age is the target for the first pillar of the WHO global strategy for cervical cancer elimination,” said Kate O’Brien, MD, MPH, director of the Department of Immunization, Vaccines and Biologicals at the WHO. “Given the continuing supply challenges, this addition of single-dose vaccine product means countries will have greater choice of vaccines to reach more girls.” The adoption of a single-dose HPV vaccination schedule helped immunize at least six million more girls in 2023, according to WHO estimates.1
More U.S. Parents Reject HPV Vaccine Over Safety Concerns
The announcement of a novel single-dose HPV vaccine prequalification from the WHO follows a 2023 study that found a growing number of parents in the U.S. are rejecting HPV vaccines for their children over safety and other concerns. The study was published in the June 2023 edition of the journal Pediatrics.
Researchers found that parents most often cited “safety or side effects” as a reason for opting out of the three-dose series and the numbers of parents declining to give their children HPV vaccine because of safety concerns increased significantly by 15.6 percent annually from 2010 to 2018. Also topping the list of cited reasons for opting out of the vaccine were “Not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”3
Plaintiffs have filed over 200 lawsuits against Merck since 2022 involved minors. Plaintiffs allege they experienced severe side effects from the Gardasil HPV vaccine that included autoimmune disorders, premature ovarian failure, and even developed the types of cancers the vaccine was supposed to prevent.
Court documents suggest that critical research was ignored or never conducted and highlighted potential conflicts of interest among members of the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). Merck has denied the allegations, pledging to “vigorously defend against these cases.” With expert depositions underway and trials set for 2025, it is well-documented that, as with most lawsuits of this nature, the initial filings will likely encourage many more plaintiffs to come forward.4 5
Merck’s Gardasil Projected to Generate $10 Billion in 2024
In July, Merck’s shares fell nearly 10 percent after a sharp decline in Gardasil sales in China. Alongside Keytruda, the world’s top-selling chemotherapy drug and one of Merck’s biggest moneymakers, Gardasil has been a key contributor to the company’s revenue. Despite this setback, Gardasil’s sales have more than doubled since 2020, and the vaccine is still projected to generate $10 billion for Merck in 2024.
Merck plans to conduct multi-year safety and efficacy trials on its Gardasil 9 vaccine beginning in Q4 of 2024 to determine whether a single-dose regimen offers the same long-term protection as the current three-dose regimen. Also in the pipeline for the company this year are human trials for a different experimental HPV vaccine that targets multiple types of the HPV virus.6 7
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