GSK's Cervarix Two-Dose Regimen Approved in China for Girls Aged 9–14

Recently, GSK announced that based on the review results from the National Medical Products Administration (NMPA), its HPV vaccine Cervarix (Bivalent Human Papillomavirus Adsorbed Vaccine [HPV16/18]) has been approved for a two-dose vaccination schedule for girls aged 9-14. As a result, Cervarix has become the first imported HPV vaccine in China to gain approval for a two-dose vaccination schedule for girls aged 9-14.

Persistent infection with high-risk human papillomavirus (HR-HPV) in the female reproductive tract is the leading cause of cervical cancer. Among malignant tumors of the female reproductive system in China, cervical cancer ranks first in both incidence and mortality rates. In 2020, there were approximately 110,000 new cases of cervical cancer and about 59,000 deaths in China, with an increasing trend in both incidence and mortality rates, as well as a trend toward younger age groups. Epidemiological studies show that HPV16 and HPV18 are the most common high-risk HPV types in cervical cancer. In China, about 84.5% of squamous cell carcinoma of the cervix cases are associated with these two high-risk HPV infections.

Vaccination against HPV in eligible female populations will significantly reduce the incidence of cervical cancer and precancerous lesions, thereby alleviating the disease burden. Since HPV is primarily transmitted through sexual contact, girls aged 9-14 who have not yet engaged in sexual activity are the primary target group for HPV vaccination. To achieve the goal of fully eliminating cervical cancer by the end of this century, the World Health Organization (WHO)’s Global Strategy to Accelerate the Elimination of Cervical Cancer has set a phased target for 2030, which includes ensuring that 90% of girls complete the full course of HPV vaccination by the age of 15 by 2030.

The 2017 WHO HPV Vaccine Position Paper explicitly recommends that females aged 9-14 receive two doses of the HPV vaccine. The two-dose vaccination schedule recently approved for Cervarix indicates that girls aged 9-14 can opt to receive one dose each at months 0 and 6 to complete the immunization process. Research shows that the antibody levels induced by two doses (administered at months 0 and 6) in girls aged 9-14 against HPV types 16 and 18 are similar to those observed in females aged 15-25 who receive three doses (administered at months 0, 1, and 6). It has been demonstrated that the immune response in females aged 9-14 vaccinated with two doses of Cervarix following the 0- and 6-month schedule can persist for at least 60 months. Mathematical models predict that the HPV16/18 antibody levels produced by 95% of recipients, which exceed those from natural infection, could last more than 21 years.

Cervarix is currently the only HPV vaccine that uses an innovative adjuvant system, which incorporates the findings of the 2011 Nobel Prize in Physiology or Medicine. An adjuvant system is a combination of two or more adjuvants (such as immune enhancers) that leverage the synergistic effects of different components to enhance the body's immune response to vaccination. Its function ranges from simply boosting immune responses to influencing the quality of the immune response, providing recipients with efficient and long-lasting protection. Studies have shown that the application of the same innovative adjuvant system used in Cervarix can induce higher immune responses compared to natural immunity and HPV vaccines with the same antigen but using aluminum salt adjuvants, thereby offering stronger and more durable protection.

Moreover, as the first HPV vaccine globally approved for a two-dose regimen in girls aged 9-14, Cervarix has the longest experience in two-dose applications so far. The two-dose regimen of Cervarix was approved by the European Medicines Agency (EMA) in 2013 and has now been approved in approximately 100 countries, including all EU nations, as well as countries in Asia, Africa, and Latin America, for the prevention of cervical epithelial lesions at all levels and cervical cancer in girls aged 9-14. In numerous clinical studies both within and outside China, as well as in long-term practical use, Cervarix has demonstrated good tolerability.

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