Gardasil®: the European Committee for Human Medicines has Approved a Variation Stating its Long-term Protection Data

News provided by

Sanofi Pasteur MSD

04 Sep, 2014, 15:45 GMT

LYON, France, September 4, 2014 /PRNewswire/ --

Immunogenicity and Effectiveness data from the long-term follow-up of Gardasil studies demonstrate a sustained protection against HPV 6, 11, 16 and 18 disease

Sanofi Pasteur MSD announced today that the Summary of Product characteristics (SmPC) of Gardasil has been updated to include new data related to long-term protection. [1]  

To view the Multimedia News Release, please click:

http://www.multivu.com/players/English/72762517-sanofi-pasteur-MSD-gardasil/

The duration of protection of Gardasil is being monitored through different long-term extension studies from clinical trials in a number of countries. The follow-up will continue to reach 10 years.[1]

The current available data show sustained protection against clinical disease irrespective of age or sex.

In the extension study for girls and boys aged 9 to 15 years at first vaccination, protection against vaccine-type HPV diseases is maintained at 6.5 years post-vaccination. The total extension period is planned for 10 years. [1]

In addition, in the extension of a study in women vaccinated at 16-23 years of age, no cases of cervical pre-cancers due to vaccine-type HPV were detected up to approximately 8 years. In the same study, durable protection was statistically demonstrated to about 6 years. The follow-up in this population will continue to reach 14 years. [1]

These studies also show that the immune response persists after a follow-up of 8 years for 9-15 year-old adolescents and 9 years for women 16-23 years old. [1]

As written in the Committee for Medicinal Products for Human Use (CHMP) report, the administration of Gardasil to 9 to 15 years girls and boys was generally well tolerated through 8 years post-vaccination follow-up. [1]

Data from long-term follow-up studies also support the long term safety of Gardasil in the other populations studied. [1]

The CHMP report concluded that "immunogenicity and effectiveness data from the long-term follow-up of Gardasil studies demonstrate continued protection against HPV 6, 11, 16 and 18 disease." [1]

This significant update comes in addition to the recent improvements of Gardasil product profile, with a new indication to prevent anal cancer and precancerous anal lesions as well as a schedule of 2 doses 6 months apart for adolescents of 9 to 13 years old. [2]  

References 

  1. CHMP Assessment report, June 2014.
  2. Gardasil SmPC, June 2014.  

Video: 
     http://www.multivu.com/players/English/72762517-sanofi-pasteur-MSD-gardasil/