Merck's 9-Valent HPV Vaccine Expands Eligible Population in China to Females Aged 9–45

At 7:30 PM on August 30, the WeChat account "MSD China" announced that the new indication for its nine-valent human papillomavirus vaccine (nine-valent HPV vaccine) had been approved by the National Medical Products Administration of China. This approval marks the expansion of the eligible population for MSD's nine-valent HPV vaccine in China to include females aged 9-45. Previously, this vaccine was approved for marketing in China in 2018, with the eligible age group being females aged 16-26.

The nine-valent HPV vaccine adopts a three-dose immunization schedule, which is suitable for preventing cervical cancer caused by HPV16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN1/2/3) and adenocarcinoma in situ (AIS) caused by HPV6, 11, 16, 18, 31, 33, 45, 52, and 58, as well as persistent infection caused by HPV6, 11, 16, 18, 31, 33, 45, 52, and 58.

On August 28, at the "Pujiang Innovation Forum," Andre Carvalho, a senior scientist at the World Health Organization's International Agency for Research on Cancer, stated that cervical cancer has a relatively high incidence worldwide. The overall incidence of cervical cancer in China is not very high, but because of China’s large population, it accounts for 18% of the global incidence of cervical cancer. Regarding cervical cancer mortality rates, Africa and Southeast Asia have higher rates, and while China’s mortality rate is not particularly high compared to other countries, due to its large population, it accounts for 17% of the total mortality rate.

On May 30, 2022, at a press conference held by the National Health Commission of China, Wang Linhong, Chairperson of the Women's Health Care Branch of the Chinese Preventive Medicine Association and Chief Expert on Chronic Diseases at the Chinese Center for Disease Control and Prevention, stated that authoritative data now shows that cervical cancer and precancerous lesions are related to high-risk HPV infections. Therefore, vaccinating eligible females with the HPV vaccine is an important measure for effectively preventing and controlling HPV infection, thereby reducing the incidence of cervical cancer.

As of now, five HPV vaccines have been approved for registration in China, including three imported HPV vaccines and two domestically produced vaccines. Among them, the imported vaccines are GlaxoSmithKline's bivalent HPV vaccine, MSD's quadrivalent HPV vaccine, and MSD's nonavalent HPV vaccine, while the domestically produced HPV vaccines include the bivalent HPV vaccine from Wantai Biologic and the bivalent HPV vaccine from Walvax Biotechnology.

Among them, in China, the applicable age for imported bivalent and quadrivalent HPV vaccines is 9-45 years old, while before approval, the applicable age for the imported nonavalent HPV vaccine was only 16-26 years old. Despite the expanded age range for this imported vaccine, experts from the Shanghai Municipal Center for Disease Control and Prevention still emphasize that HPV vaccination cannot replace cervical cancer screening. Combining vaccination with cervical cancer screening remains the best approach for preventing cervical cancer. They recommend that women aged over 20 or those with more than three years of sexual activity undergo cervical cancer screening once a year.

Besides imported HPV vaccines, among the two domestically produced HPV vaccines in China, the Walvax Biotech's bivalent HPV vaccine is suitable for individuals aged 9-45 and was launched in 2018; the Walvax Biotech's bivalent HPV vaccine targets females aged 9-30 and was launched in 2022. Currently, the domestically produced bivalent HPV vaccine has also become the preferred choice for free vaccination programs in many places across China.