There is also an HPV vaccine that can reduce the number of doses administered. This time, it is the turn to import the nine valent HPV vaccine.
On the afternoon of January 9, 2024, MSD announced that its nine valent human papillomavirus vaccine (brewing yeast) (trade name: Jiada Xiu 9) has been approved by the National Medical Products Administration of China for the second dose vaccination program for women aged 9 to 14 (from June to December).
This approval means that on the basis of the previous three dose vaccination program for the ages of 9 to 45, the vaccine will add a two dose vaccination program for the ages of 9 to 14.
From a pharmacoeconomic perspective, simplifying vaccination procedures can reduce vaccination costs by about one-third, while improving vaccine accessibility while preventing diseases.
Cervical cancer is one of the common gynecological malignancies. According to the 2023 ICO/IARC report on HPV and related diseases in China, the incidence rate and mortality of cervical cancer will rank third among women aged 15-44 in 2020. In China, about 98% of cervical cancer is caused by high-risk HPV (human papillomavirus).
Professor Qiao Youlin from the School of Group Medicine and Public Health at the Chinese Academy of Medical Sciences/Peking Union Medical College stated that girls aged 9 to 14 are the primary group recommended by the World Health Organization for vaccination. Receiving the HPV vaccine can stimulate better immune responses, and women who have not engaged in sexual activity will receive the best preventive effect. For eligible women aged 9 to 14 in China, the second dose vaccination program from 0 to 6 to 12 months simplifies the vaccination process, releases more vaccine resources, and further promotes the increase in vaccination rates for young women in China, helping to accelerate the elimination of cervical cancer.
In April 2022, the World Health Organization held a meeting of the Immunization Strategy Expert Group (SAGE) to review the evidence of single dose HPV vaccination. The conclusion was that a single dose HPV vaccination regimen can effectively prevent cervical cancer caused by persistent HPV infection and is equivalent to the effectiveness of two or three dose regimens. At that time, SAGE recommended using the following immunization program: women aged 9 to 14 years old (top priority population) were vaccinated with a single or two doses; Women aged 15 to 20 receive one or two doses of vaccination; Women over 20 years old should receive two doses (with a 6-month interval).
The recommendations put forward by the World Health Organization are also based on concerns about the slow introduction of HPV vaccines into immunization programs and low overall population coverage. As early as November 2020, the World Health Organization released the Global Strategy to Accelerate the Elimination of Cervical Cancer, with one goal being to achieve HPV vaccination for 90% of girls before the age of 15 by 2030. Reducing the number of doses administered may potentially accelerate the achievement of this goal.
Before Merck announced that its nine valent HPV vaccine could reduce the number of doses administered, another imported HPV vaccine manufacturer, GlaxoSmithKline, also announced in April 2023 that it would simplify the vaccination process for its bivalent HPV vaccine for girls aged 9-14, shifting from a "three dose" to a "two dose" approach.
Whether in China or globally, MSD's Jiada Xiu 9 is the only nine valent HPV vaccine approved for market launch. In the Chinese market, this vaccine has become a scarce commodity, causing a shortage of supply and demand. However, the market dominance of this HPV vaccine is facing challenges, and at least five Chinese manufacturers are currently researching the nine valent HPV vaccine, which has entered the phase three clinical trials.
It can be said that Merck has been responding in advance. In addition to expanding the female vaccination population, it also submitted an application for the listing of the Jia Da Xiu 9 male adaptation certificate in China in September 2023. According to Sullivan data, in China, in 2020, 344 million men (aged 9-45) were suitable for receiving the HPV vaccine, and the corresponding vaccine required to achieve complete vaccination was approximately 980 million doses.