Showing posts with label EMA. Show all posts
Showing posts with label EMA. Show all posts

Monday, 2 December 2013

GSK's Cervarix two-dose schedule receives positive opinion from EMA


European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of a two-dose schedule of GlaxoSmithKline's (GSK) cervical cancer vaccine, Cervarix, in girls aged nine to 14. 

Cervarix is a vaccine against certain types of cancer-causing human papillomavirus(HPV).
Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix also contains AS04, a proprietary adjuvantthat has been found to boost the immune system response for a longer period of time.
Cervarix is manufactured by GlaxoSmithKline. An alternative product, from Merck & Co., is known as Gardasil.
The vaccine was developed, in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, theUniversity of Queensland in Australia, and the U.S. National Cancer Institute.

Clinical Trials

Phase III trials have been conducted, including over 18,000 women from 14 countries in Pacific Asia, Europe, Latin America and North America.
As of 2009 the manufacturer was conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil. Subsequent studies showed Cervarix generated higher antibody levels than Gardasil, the other commercally available HPV vaccine, upon testing seven months later, with twice the level for HPV type 16 and six times for HPV type 18.In addition Cervarix induced twice as many memory B cells as Gardasil for both these HPV strains.


Vaccine description
Target diseasehuman papillomavirus (Types 16 and 18)
TypeProtein subunit