Production of First Domestic HPV Vaccine in China

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On January 2nd, 2020, the National Medical Products Administration announced China's approval of its first domestic production of the HPV vaccine. It is hard to believe that the first HPV vaccines arrived in mainland China just 3 years ago. Prior to 2017, any types of HPV vaccines were unavailable among citizens and residents in public hospitals across China. In 2015, I was only able to receive my three shots of Gardasil 4vHPV imported from Hong Kong in the Shanghai East International Medical Center, in Shanghai, China under my special circumstance of going to the United States for high school.

Genital human papillomavirus (HPV) is a common sexually transmitted virus that can infect genital areas as well as mouth and throat areas of men and women. Nearly all men and women who are sexually active, at some point in their lives, get at least one HPV infections that go away within two years. However, HPV infections sometimes prevail and cause different types of cancers. Long-lasting HPV infections on cervix sometimes develop into cervical cancer on women. HPV can also be transmitted to the mouth and throat areas by oral sex, and a long-lasting infection can lead to oropharyngeal cancer. Despite detrimental effects of cervical and oropharyngeal cancer on health, they are highly preventable through vaccination. Due to its health threats to both genders, HPV vaccines are recommended for all boys and girls between age 11 and 12 with the second dose given 6 to 12 months after the first. HPV vaccines can be given as early as age 9; once the recipient of the vaccine passes age 15, he or she needs to receive three shots over 6 months. HPV vaccine protects recipients against HPV infections, genital warts, cervical and oropharyngeal cancer prior to their exposure to the virus. Since 2014, World Health Organization (WHO) has advocated for national immunization programs to include HPV vaccines in the effort to prevent cervical cancer and other HPV-related diseases (WHO).

Currently, there are two types of globally-predominant HPV vaccines: Gardasil and Cervarix. Gardasil four-valent and nine-valent vaccines are the world’s first HPV vaccines, developed by Merck and Co., a U.S. pharmaceutical company. Cervarix is a two-valent HPV vaccine that was developed by GlaxoSmithKline, a British pharmaceutical company. It was not until July, 2016, a decade after the first HPV vaccine’s licensing in the USA, when Cervarix was approved by the China Food and Drug Administration for sale in mainland China. This is the first time HPV vaccines were officially introduced to China. Cervarix became available in mainland China in August, 2017, and Gardasil did not become available to the majority of the Chinese provinces until 2018.

Cecolin - China’s first domestically made HPV vaccine co-developed by Xiamen Innovax Biotech Co. Ltd. and Xiamen University - was granted production permission by the National Medical Products Administration in January 2020. Cecolin targets type 16 and 18 HPV towards girls and women aged 9 to 45. Its date of availability on the Chinese market is yet to be determined.

In 2005, China had already launched the Program of Early Detection, Diagnosis and Treatment for Cervical Cancer, but HPV vaccines never made it to China. The unavailability of HPV vaccines was due to the lack of demand in China prior to 2015. Awareness of HPV and its connection with cervical and oropharyngeal cancer was nearly nonexistent prior to the introduction of Cervarix in China. Limited number of people in China had a good knowledge towards the virus. However, in 2015, over 111,000 new cases of cervical cancer were reported in China, accounting for one-third of cases globally and half of all cases in Asia. Cervical cancer was reported as the second most common type of cancer among women in China. With the report as well as the universality of social media in China, research, articles and information about HPV and HPV vaccines were introduced to the public. And as Cervarix became available, the anxious middle class in China were invested in vaccination to safeguard the health from this “new” virus. Demand for the vaccine surged between 2017 to 2019, causing nationwide shortages. Despite the high demand for HPV vaccines, a large portion of the Chinese population are still not vaccinated. Imported HPV vaccines are expensive and not covered by the Chinese health insurance. A single injection of Cervarix costs 580 yuan ($83) and the total cost adds up to 1740 yuan. The high prices made HPV vaccines inaccessible to the lower-working class in China.

With the approval of Cecolin, HPV vaccine can now be domestically produced and could potentially be covered by the Chinese health insurance. Innovax predicts that the price for each shot of Cecolin will fall around 329 yuan ($47), which is almost half the price of imported HPV vaccines. The availability of Cecolin in China will give the low- and middle-income families access to HPV vaccines.

Nonetheless, the future of HPV vaccination in China still faces many challenges. Cecolin only provides protection against two HPV strains, and HPV vaccination in mainland China is only available to people within the officially sanctioned age range: Gardasil 4 is only authorized for women aged 20 to 45 and Gardasil 9 for age 16 to 26. There is not a full accessibility to vaccination for women in mainland China who choose to receive the more effective HPV vaccines. But undoubtedly, the approval and introduction of Cecolin in China will bring great advances in prevention for long-lasting HPV infections and cervical cancer in China.

More posts by Jiacheng Shen.
Production of First Domestic HPV Vaccine in China
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