HPV 9-valent vaccine expands age limit! Here are some things you must know about HPV →

Recently, the website of the National Medical Products Administration showed that the indications of Merck's nine-valent human papillomavirus vaccine (brewer's yeast) (hereinafter referred to as the nine-valent HPV vaccine) have been expanded, and the applicable population has been expanded to women aged 9 to 45 years old.

On the same day, Merck also released news that the new indication of the nine-valent HPV vaccine was approved by the National Medical Products Administration. Subsequently, "HPV nine-valent vaccine expanded to 9 to 45 years old" quickly became the number one trending search on Weibo.

The age limit for the 9-valent HPV vaccine is extended to 45 years old

Cervical cancer is one of the most common gynecological malignancies. The 2021 ICO/IARC Report on HPV and Related Diseases in China shows that in 2020, the incidence and mortality of cervical cancer ranked third among female tumors among women aged 15 to 44 in China.

HPV vaccines are divided into bivalent, quadrivalent and nonavalent vaccines according to the types of virus subtypes covered by the vaccine, and each vaccine is suitable for a slightly different age range.

7. The bivalent HPV vaccine is suitable for ages 9 to 45 and covers HPV types 16 and 18;
8. The quadrivalent HPV vaccine is suitable for people aged 20 to 45 years old and covers HPV types 6, 11, 16, and 18.
9. The nine-valent HPV vaccine covers HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and is suitable for people aged 16 to 26. Many women are forced to give up the nine-valent HPV vaccine because they are over the age limit. Previously, Merck's imported four-valent HPV vaccine had been expanded to women aged 9 to 45 in China . After this approval, the four-valent and nine-valent HPV vaccines under Merck are both for women aged 9 to 45 in China .

Anna Tian, ​​global senior vice president of Merck, said that the expansion of the applicable age of the nine-valent HPV vaccine demonstrates the Chinese government's determination to accelerate the elimination of cervical cancer. Merck will increase the accessibility of HPV vaccines by expanding global production capacity and increasing supply to the Chinese market.

The nine-valent HPV vaccine is still hard to come by

At present, the HPV vaccines that have been approved for marketing in my country include the imported Merck quadrivalent vaccine "Gardasil" and the nine-valent vaccine "Gardasil 9", the bivalent vaccine "Cervarix" from GlaxoSmithKline, and the domestic bivalent vaccine "Xinkening" from Wantai Bio and the bivalent vaccine "Wozehui" from Watson Bio. Currently, the nine-valent HPV vaccine is the most expensive vaccine available on the market for protection against HPV virus, and it is also the most popular vaccine among the vaccinated population.

However, the penetration rate of the nine-valent HPV vaccine still cannot meet the huge market demand , and it is difficult to get a shot. Since it was approved for marketing in China in 2018, Merck has increased the supply of the nine-valent HPV vaccine every year. Zhifei Bio is the domestic agent of Merck's HPV vaccine. Its 2022 semi-annual report shows that from January to June 2022, the number of nine-valent HPV vaccines issued reached 9.2987 million, a year-on-year increase of 379.34%.

Merck also disclosed in its 2022 semi-annual report that in the first six months of this year, sales in China increased by 87% year-on-year to US$2.57 billion. Merck specifically stated that in recent quarters, demand for Gardasil in the Chinese market has continued to be high, continuously driving the company's business expansion in China.

Several domestic nine-valent HPV vaccines have entered Phase 3 clinical trials

In addition to Merck, the Drug Clinical Trial Registration and Information Disclosure Platform shows that in China, there are currently five companies, including Kangleweishi Wantai Bio, Bowei Bio, Ruike Bio, and Zerun Bio (a subsidiary of Watson Bio), conducting Phase 3 clinical trials of the nine-valent HPV vaccine . Except for Zerun Bio, the upper age limit of the clinical trial registered by the other four companies is 45 years old.

On the morning of August 31, Wantai Biological told reporters that the head-to-head clinical trial of the company's nine-valent HPV vaccine and Merck's nine-valent HPV vaccine has completed the clinical trial site and specimen testing, and data statistical analysis is underway. The younger age bridging clinical trial has completed enrollment.

Liu Jun, deputy chief physician of the Department of Obstetrics and Gynecology at Beijing Chaoyang Hospital affiliated to Capital Medical University, said that it is not recommended to blindly pursue the nine-valent HPV vaccine, but rather to get vaccinated in a timely manner at the appropriate age . Liu Jun said that the bivalent and quadrivalent HPV vaccines can also have a good preventive effect, and it is not recommended to wait for a higher-valent vaccine in order to increase the scope of protection and miss the best prevention opportunity. HPV vaccination is an important measure to prevent cervical cancer. Will HPV infection definitely lead to cervical cancer? What is the difference between the bivalent, quadrivalent, and nine-valent vaccines?

Source: Beijing Evening News WeChat Official Account, CCTV Finance