HPV vaccines in the USA - CERVARIX still unlicensed, GARDASIL not for over-26 year olds: CERVARIX, the second vaccine against human papilloma viruses available in Germany since autumn 2007, will not obtain a licence in the USA for the time being. The manufacturer GlaxoSmithKline (GSK) expects this in late 2009 at the earliest. In Europe, the evidence for the benefit of CERVARIX is based essentially on an interim analysis of the multicentre PATRICIA* trial with a mean follow-up period of 15 months after the first vaccination. This does not appear to be sufficient for the USA (HIRSCHLER, B.: Reuters Health Information of 30 June 2008; Scrip 2007; No. 3321: 24; a-t 2007; 38: 101-3). Merck & Co., the American supplier of GARDASIL, also has to put up with set-backs: both an extension of the licence to women aged between 27 and 45 years and also a statement of the protective effect of the vaccine beyond the four HPV types contained were refused for the American product information (KRAUSKOPF, L.: Reuters Health Information of 25 June 2008). According to hitherto unpublished data from a study with 3.819 24- to 45-year old women without a prior history of genital warts, hysterectomy or loop excision and without cervical biopsy in the previous five years, no statistically significant protection by the vaccine against higher-grade dysplasia of the cervix (CIN 2 or greater) could be confirmed within an average of 2.2 years (protective effect 75.2%; 95% confidence interval -150.6% to 99.5%). However, only five such lesions occurred in the analysed per protocol population, one of them in the treatment group (DUNNE, E.: presentation at the meeting of the Advisory Committee on Immunization Practices [ACIP] of 25 June 2008; http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun08/20-3-hpv.pdf - ati d). Since nothing has come of the hoped-for extension of the licence to "older" women for the time being, the only thing left to Merck is to apply for a licence for men planned for the end of the year. Ultimately, the sales of GARDASIL should continue to rise. This may also explain why an "elite German academy" is writing to doctors and calling to continue vaccinating. After two deaths in Europe were linked with GARDASIL (a-t 2008; 39: 17-8), the number of doses of vaccine given weekly is said to have fallen at times by up to two thirds (WILLE, J.: Frankfurter Rundschau online on 17 June 2008). Incidentally, among the academy's "advisers" is the chairman of the board of the German GARDASIL supplier Sanofi Pasteur MSD, -ed.