NONAVALENTE HPV VACCINE
The FDA, the agency of the Department of Health and Human Services US, approves nonavalente vaccine for the prevention of certain cancers caused by HPV types 16, 18, 31, 33, 45, 52, 58 and for the prevention of genital warts caused by HPV types 6 or 11.
The Food and Drug Administration approved December 10, 2014, the Gardasil 9 (9-valent vaccine for human papillomavirus recombinant) for the prevention of certain diseases caused by HPV types 9. With nine types of HPV (five more than previously approved Gardasil from 'FDA), Gardasil 9 has the potential to prevent about 90 percent of cervical cancers, vulvar, vaginal and anal caused by types 16, 18, 31, 33 , 45, 52 and 58, and for the prevention of genital warts caused by the 6 or 11.
9 Gardasil is a vaccine approved for use in women aged between 9 and 26 and in males ages 9 to 15. Gardasil 9 adds protection against 'HPV-31, 33, 45, 52 and 58, which cause about 20 percent of cervical cancer cases and HPV vaccines are not covered by previously approved by 'FDA.
"Vaccination is a fundamental means for public health in reducing the risk of the majority of cervical cancers, genital and anal caused by HPV," said Karen Midthun, MD, director of the Center for Biologics Evaluation FDA and Research. "The approval of Gardasil 9 provides a 'broad protection against HPV-related cancers."
A randomized clinical trial was conducted in the United States and internationally, in about 14,000 females aged 16 to 26 who were negative for HPV types in the vaccine to the start of the study. Participants received either that Gardasil and Gardasil 9.
Gardasil 9 has proven to be 97 percent more effective in preventing cervical cancer, vulvar and vaginal caused by the five additional types of HPV (31, 33, 45, 52, and 58) . Also, Gardasil 9 is effective as Gardasil for the prevention of disease caused by four common HPV types (6, 11, 16, and 18) on the basis of antibody responses similar to participants in clinical trials.
9 Gardasil is administered in three separate doses, subsequent doses are administered at 2 and 6 months after the first. The safety of Gardasil 9 was evaluated in 13,000 males and females. The most commonly reported adverse reactions were pain at the injection site, swelling, redness, and headaches.
PAPER ON UNIVERSAL HPV VACCINATION
With the support of the Fondazione Giovanni Lorenzini and the coordination of the Vice-President Andrea Peracino, was developed a document on Vaccination HPV universal, and published by Sole 24 Ore Health for the series "The Notebooks".
The Authors (Riccardo A. Audisio -St. Helens, UK-; Giancarlo Icardi -Genova-; Andrea M. Isidori -Roma-; Charles A. Liverani -Milan-; Alberto Lombardi -Milan-; Luciano Mariani -Roma-; Francesco Saverio Mennini -Roma-; Sergio Pecorelli -Brescia-; Andrea Peracino -Milan-; Giovanni Rezza -Roma-; Carlo Signorelli -Parma-; Giovanni Vitali Rosati -Firenze-; Gian Vincenzo Zuccotti -Milan-) face in the 50 pages of the document the value of health, social and economic impact of HPV vaccination universal.
Some vaccines, such as the one against the Human Papillomavirus (HPV), have so far been allocated from the Public Health for use in a single population "target", the female adolescent. The pathology HPV is, however, even for males, a problem of significant size social care, considering among other things that vaccines mono-genre have usually shown limited effectiveness. In fact, up to now the focus towards vaccination has always focused on the prevention of cervical cancer, rather than assessing the overall effects of HPV-related disease that instead, as shown by many studies, represents about 40% of 'whole load of oncological disease HPV in both sexes. The HPV-related disease is approximately 1/3 of the males charged. The male, besides being the reservoir of infection, is himself at risk of cancer from HPV. Moreover, the evidence shows that vaccinating males also helps to protect the girls unvaccinated. In other words, the reduction of the share "assets" of HPV also through vaccination determines male superior protection in the community also compared to high vaccination coverage rates in women.
These new perspectives therefore lead to a reassessment of the current vaccination strategy. The path followed in this paper contains the outlook at the time drawn, showing how increasingly demand proper identification of the needs of women and men.
The document is fully downloaded from the website of the Fondazione Giovanni Lorenzini (www.lorenzinifoundation.org).Read More