GlaxoSmithKline HPV Vaccine Two-dose Schedule Approved in China

Recently, GlaxoSmithKline (GSK) announced that, according to the review results of the National Medical Products Administration (NMPA), its HPV vaccine Cervarix (bivalent human papillomavirus adsorbed vaccine [HPV16/18]) is suitable for 9 - A two-dose schedule for 14-year-old girls has been approved. As a result, Cervarix has become the first imported HPV vaccine approved in China for a two-dose vaccination program for girls aged 9-14.

Persistent infection of high-risk human papillomavirus (HR-HPV) in the female genital tract is the main cause of cervical cancer. Epidemiological studies have shown that HPV16 and HPV18 are the most common high-risk HPV types in cervical cancer. Vaccination of HPV vaccine among school-age women will significantly reduce the incidence of cervical cancer and precancerous lesions, thereby reducing the disease burden. Because HPV is mainly transmitted through sexual contact, girls 9-14 years old who have not had sex are the first population to receive the HPV vaccine.

According to public information, Cervarix is currently the only HPV vaccine that uses an innovative adjuvant system that embodies the achievements of the 2011 Nobel Prize in Medicine or Physiology. An adjuvant system is a combination of two or more adjuvants (such as immune enhancers) that utilize the synergistic action of different components to enhance the body's immune system's response to vaccination, ranging from simply enhancing immune responses to affecting immune responses quality, providing efficient and long-lasting protection to vaccinators. Studies have shown that the application of the same innovative adjuvant system as Cervarix can induce a higher immune response than natural immunity and HPV vaccines adjuvanted with the same antigen and aluminum salt, thereby providing stronger and longer-lasting protection.

According to the press release, Cervarix's approved two-dose vaccination program means that girls aged 9-14 can choose to receive one dose of the vaccine in the 0th and June months to complete the immunization program. The study showed that girls aged 9-14 received two doses (one dose each at months 0 and 6) compared to a three-dose schedule for women aged 15-25 (one dose each at months 0, 1, and 6). ) induced HPV 16 and 18 antibody levels similar to those in the 15-25 year old population who received three doses. Studies have shown that when women aged 9-14 are vaccinated with 2 doses of Cervarix according to the 0 and 6 month immunization schedule, the immune response can last for at least 60 months; Naturally infected HPV16/18 antibodies can persist for more than 21 years.