The FDA has approved the HPV vaccine for women and men aged 27 to 45, in an effort to continue driving down the rate of HPV-related diseases and cancers. Photo by huntlh/Pixabay
美国食品和药物管理局扩大Gardasil-9（一种HPV疫苗）的使用范围，包括27岁到45岁的妇女和男子。之前在2014年已经批准使用Gardasil 9用于9到26岁的男性和女性。该疫苗是由默克公司、夏普和多姆公司制造。
FDA生物评价和研究中心的主任Peter Marks博士在一份声明中说，这项批准“代表了在更广泛的年龄范围内帮助预防HPV相关疾病和癌症的重要机会。”
该疫苗可预防由九种人乳头瘤病毒引起的癌症和疾病。相关的更多青少年需要注射HPV以满足公共卫生目标。
在美国目前有近8000万人（约四人中有1人）被感染。每年大约有12000名妇女被诊断为宫颈癌，4000名妇女死于某些HPV病毒引起的癌症。HPV病毒与其他几种影响男性和女性的癌症相关。
CDC认为，这种疫苗有潜力预防90%以上的癌症，每年控制31200例癌症从此不再发展。
2006年FDA批准GARDASIL以预防由四种类型HPV引起的一些癌症和疾病。由于新版本的疫苗Gardasil 9覆盖了相同的四种类型HPV和另外的五种类型的HPV，因此之前的版本不再使用。
一项试验跟踪了大约3200名女性，年龄从27岁到45岁，平均为3.5岁。Gardasil 9预防持续性感染、生殖器疣、外阴和阴道癌前病变、宫颈癌前病变和与疫苗覆盖的HPV类型有关的宫颈癌的联合终点有效率为88%。
另外，150名年龄在27至45岁的男性在6个月内接受了GARDASIL的3次给药方案，并且同样有效。
Oct. 8 (UPI) -- The U.S. Food and Drug Administration has expanded the use of Gardasil 9 -- a vaccine for HPV -- to include women and men age 27 through 45.
The U.S. agency, which made the announcement Friday, had approved the use of Gardasil 9 for use in men and women 9 through 26 in 2014. The vaccine is manufactured by Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
The approval "represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement.
The vaccine prevents cancers and diseases caused by the nine types of human papillomavirus.
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Nearly 80 million people -- about one in four -- are currently infected in the United States. About 12,000 women become diagnosed with cervical cancer and about 4,000 women die from the cancer caused by certain HPV viruses each year. HPV viruses are associated with several other forms of cancer affecting men and women.
The vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing, according to the CDC.
In 2006, the FDA approved Gardasil to prevent certain cancers and diseases caused by four HPV types. It no longer is distributed in the United States because a new version of the vaccine, Gardasil 9, covers the same four HPV types and an additional five types. Results from clinical trials of the previous version remain relevant though.
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A trial followed approximately 3,200 women 27 through 45 years of age for an average of 3.5 years. Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesionsand cervical cancer related to HPV types covered by the vaccine.
Also, 150 men age 27 through 45 received a 3-dose regimen of Gardasil over 6 months, and it was just as effective.
Gardasil 9's safety was evaluated in about 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.
RELATED CDC: HPV vaccination rates rising among U.S. teens
The FDA gave the vaccine priority review status, which facilitates and expedites the review of medical products for a serious or life-threatening condition.
Topics Food and Drug Administration
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