HPV vaccine Gardasil 9 is approved by European drug regulator

A human papillomavirus (HPV) vaccine that protects against nine different strains of the virus has been given preliminary approval by the Committee on Medicinal products for Human Use (CHMP), part of the European Medicines Agency.

In addition to the four strains of HPV (6, 11, 16 and 18) that the Gardasil vaccine protects against, the Gardasil 9 (Sanofi Pasteur MSD) vaccine protects against diseases caused by five additional HPV strains (31, 33, 45, 52 and 58). The vaccine is given as three separate injections.

Gardasil 9’s effectiveness was evaluated in four main clinical studies and its safety in seven studies, the CHMP reports. The committee recommended Gardasil 9 for use in boys and girls from nine years of age to protect against cervical cancer and pre-malignant cervical lesions, vulvar and vaginal cancers and pre-malignant vulvar and vaginal lesions, pre-malignant anal lesions and anal cancers, and external genital warts covered by nine HPV types.

The recommendation from the CHMP will now be passed to the European Commission, which will make a final decision on granting a marketing authorisation.

In the United States, the vaccine was approved by the Food and Drug Administration in December 2014.

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Citation
The Pharmaceutical Journal, PJ, 18 April 2015, Vol 294, No 7858;294(7858):DOI:10.1211/PJ.2015.20068261