Two-dose Cervarix backed by CHMP

[COLOR="#000000"]GlaxoSmithKline has been boosted by a recommendation from Europe’s regulator for approval of a two-dose schedule for Cervarix which is currently licensed as a three-dose cervical cancer vaccine.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for a two-dose schedule in nine-14 year -old girls for Cervarix (Human papillomavirus types 16 and 18 vaccine, recombinant). The recommendation comes a few weeks after Phase III data was unveiled which showed that two doses of the jab for the aforementioned age group provide an immunogenicity matching the three-dose schedule in 15 to 25 year olds.

Thomas Breuer, head of GSK Vaccines, noted that the CHMP positive opinion “represents another major milestone in our commitment to reducing the global burden of cervical cancer which remains high”. He added that “many countries are unable to implement national immunisation programmes in young adults with high coverage [and] a two-dose vaccine schedule has the potential to be easier to deliver…thereby expanding the population that could benefit from protection”.[/color]