LONDON: GSK plc (LSE/NYSE: GSK) announced today that a two-dose schedule for its HPV vaccine Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, Recombinant)] has been approved by China’s NMPA for girls aged 9 to 14. With this approval, Cervarix is the first imported two-dose HPV vaccine for this age group in mainland China.
The NMPA authorisation of the two-dose regimen adds China to two-dose approvals in approximately 100 countries, including the European Union, Asia, Africa, and Latin America2-7. The three-dose schedule remains on the label for girls and women aged 15-45 years in China.
About cervical cancer
Cervical cancer has the highest mortality of all malignant tumours in the female reproductive system in China1, with 110,000 new cases of cervical cancer and 59,000 deaths due to the disease. Incidence and mortality rates show an increasing trend in younger women8. The potential impact of vaccines against oncogenic HPV types 16 and 18 is estimated to be high (84.5%) against total squamous cell carcinoma (SCC).9
Vaccination with HPV vaccine in the female population at appropriate ages may significantly reduce the morbidity of cervical cancer and precancerous lesions, thereby reducing the burden of the disease. HPV is predominately transmitted through sexual contact; the primary target population for HPV vaccination is girls aged 9-14 years who have not yet had sex. With a two-dose schedule, more girls could be vaccinated against HPV, leading to the protection of more women against HPV-related cervical cancer.
Cervarix (Human Papillomavirus vaccine Types 16 and 18 [Recombinant, AS04 adjuvanted]) is a non-infectious recombinant, AS04-adjuvanted vaccine. Cervarix demonstrated direct evidence of lowering cervical cancer incidence rates10. A register-based study in England where girls were offered the vaccine in school year eight (aged 12 to 13 years), had an 87% reduction for cervical cancer and 97% reduction for precancerous lesions (cervical intraepithelial neoplasia, CIN, grade 3); a more significant effect than expected based on the incidence of HPV 16/18 strains (68%) included in the vaccine10. Cervarix has also shown to be effective 93·2% (78·9-98·7) against all CIN3+, irrespective of HPV type in the lesion and including lesions with no HPV 16/18 DNA detected, suggesting a wider than HPV 16/18 benefit.
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