האם כדאי לחכות לחיסון הגרדסיל החדש (גרדסיל 9)?

שאמור לספק הגנה רחבה יותר מהגרדסיל הנוכחי(גרדסיל 4). החיסון אושר בארה"ב ב 10.12.14. FDA approves Merck's 9-strain HPV vaccine The US Food and Drug Administration (FDA) today approved Merck's nine-strain human papillomavirus (HPV) vaccine, which protects against five more HPV strains than the company's already-approved Gardasil vaccine. The vaccine, called Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), may prevent about 90% of cervical, vulvar, vaginal, and anal cancers, the FDA said in a press release. It is approved for female patients 9 through 26 years old and male patients 9 through 15. It is approved for preventing those four cancers caused by HPV types 16 and 18 and for preventing genital warts caused by types 6 and 11, which are the four strains in Gardasil. In addition, Gardasil 9 protects against the four above-mentioned cancers caused by HPV types 31, 33, 45, 52, and 58. Those five strains cause about 20% of cervical cancers and are not included in either Gardasil or the other FDA-approved HPV vaccine, GSK's Cervarix, which covers types 16 and 18. A randomized, controlled trial involving 14,000 girls and women aged 16 through 26 showed Gardasil 9 to be 97% effective in preventing cervical, vulvar, and vaginal cancers caused by the five additional HPV types, the FDA said. It was also shown to be as effective as Gardasil for preventing disease caused by the four shared HPV types. Because of the low incidence of anal cancer caused by the five additional HPV types, the indication for preventing anal cancer is based on Gardasil's demonstrated effectiveness of 78% and "additional data on antibodies" in males and females who received Gardasil 9, the agency said. The safety of Gardasil 9 was evaluated in about 13,000 patients of both sexes, and the most commonly reported adverse effects were injection-site pain, swelling, and redness and headaches, the FDA said. As with Gardasil, Gardasil 9 will be administered in three separate doses, with an initial dose followed by shots 2 and 6 months later.