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Published on 8 May 2014

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Gardasil® 2-dose schedule approved in the European Union for children aged from 9 to 13 years

Sanofi Pasteur MSD announced that the European Commission has granted marketing authorisation for a two-dose schedule at 0 and 6 months in children aged from 9 to 13 years for its quadrivalent human papillomavirus (HPV) vaccine.

Gardasil® is the only quadrivalent HPV vaccine and is indicated in adolescent girls and boys to help protect against cervical cancer, vulvar and vaginal precancers and genital warts.(1)

Sanofi Pasteur MSD announced that the European Commission has granted marketing authorisation for a two-dose schedule at 0 and 6 months in children aged from 9 to 13 years for its quadrivalent human papillomavirus (HPV) vaccine.

Gardasil® is the only quadrivalent HPV vaccine and is indicated in adolescent girls and boys to help protect against cervical cancer, vulvar and vaginal precancers and genital warts.(1)

We are delighted to offer this alternative 2-dose schedule which could help to extend HPV vaccine coverage and increase uptake. It is based on data showing that 2 doses elicited an immune response in adolescents, comparable to that of 3 doses in young women, to the four HPV types – 6, 11, 16 and 18 – included in Gardasil®,” said Dr Fiona Thomas, UK Medical Director for Sanofi Pasteur MSD.

The approval of the Gardasil vaccine two-dose schedule follows the positive opinion of the European Medicines Agency (EMA), based on a Canadian study by Dobson et al. It demonstrated that the two-dose 0- and 6-month schedule in 9–13 year-old girls elicited an immune response comparable/non-inferior to that of three doses in 16 to 26-year-old women, the population where quadrivalent vaccine efficacy has been shown. These results were sustained at 36 months of follow-up.*(2)

Adolescents aged 14 years and above should still receive three doses at 0, 2 and 6 months. The UK national HPV immunisation programme continues to use a three-dose schedule for girls aged 12–13 years.* Any change to the schedule used in the national HPV immunisation programme would have to be announced by Public Health England, following advice from the Joint Committee on Vaccination and Immunisation (JCVI).

To date, more than 29 million doses of Gardasilhave been distributed in Western Europe, helping to protect the future health of millions of adolescents.(3)

*The duration of protection of a 2-dose schedule has not been established.

References

 


 


[i] Gardasil® SmPC.

[ii] Dobson SR et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women. JAMA 2013;309:1793–802.

[iii] SPMSD. Data on file 2014.



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