Sanofi Pasteur MSD UK announced that Gardasil® 9 (Human Papillomavirus 9-valent Vaccine (Recombinant, adsorbed)) is now available for use by private prescribers in the UK.
The vaccine received marketing authorisation from the European Commission (EC) in June 2015 for active immunisation of females and males from the age of nine years against premalignant lesions and cancers affecting the cervix, vulva, vagina or anus and also against genital warts (Condyloma acuminata) caused by vaccine HPV types.[1] This is based on data in males and females aged 9 to 26 years. The vaccine is now available in several European countries.
Sanofi Pasteur MSD’s 9-valent HPV vaccine contains nine HPV types: the seven high-risk HPV types (HPV 16, 18, 31, 33, 45, 52 and 58) which cause approximately 90 per cent of cervical cancer, 90 per cent of HPV related anal cancer and 80 per cent of high-grade cervical lesions (high-grade cervical pre-cancers defined as cervical intraepithelial neoplasia 2+ (CIN 2+) and adenocarcinoma in situ (AIS)) worldwide. The two low-risk types, HPV 6 and 11, cause 90 per cent of genital wart cases.[2]
Adeola Olaitan, Consultant Gynaecologist at University College London Hospitals commented: “While uptake seen in the first eight years of the national immunisation programme has been high, first with the bivalent and then with the quadrivalent vaccine, the private availability of the 9-valent vaccine gives those outside the national immunisation programme the opportunity to access this new vaccine.”
“I welcome the news that the 9-valent HPV vaccine is being made available for private patients in the UK.”
The quadrivalent HPV vaccine, Gardasil (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)), remains part of the UK childhood vaccination schedule.[3] It is important for eligible girls in school year eight to continue to be vaccinated with the quadrivalent vaccine within the national HPV vaccination programme. The availability of the 9-valent vaccine provides an opportunity for vaccination of those individuals aged 26 years and under who are not currently eligible for routine HPV vaccination.
HPV vaccination, in combination with cervical screening, forms part of the measures to help protect the population against HPV-related diseases.
References:
[1] GARDASIL 9 SmPC available from: https://www.medicines.org.uk/
[2] Hartwig et al, Estimation of the epidemiological burden of HPV-related anogenital cancers, precancerous lesions, and genital warts in women and men in Europe: Potential additional benefit of a nine-valent second generation HPV vaccine compared to first generation HPV vaccines. Papillomavirus Research 2015;1:90-100.
[3] Public Health England. Routine childhood immunisations from summer 2016. https://www.gov.uk/government/
Website: www.spmsd.com