FDA approves use of HPV vaccine for adults 27 to 45
FDA批準HPV疫苗可供27至45歲成人使用
▌ 部分素材來源於CNN，世界播團隊翻譯
(CNN)-The US Food and Drug Administration on Friday approved the use of a human papillomavirus vaccine called Gardasil 9 for men and women between the ages of 27 and 45. The FDA previously approved the HPV vaccine for people age 9 to 26.
(CNN)-美國食品和藥物管理局周五批準為27至45歲的男性和女性使用一種名為九價加衛苗的人類乳頭瘤病毒疫苗。FDA此前批準了針對9歲至26歲人群使用的的HPV疫苗。
"Today"s 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. Based on US Centers for Disease Control and Prevention numbers, Marks said, "HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing."
FDA生物製劑評估和研究中心主任彼得·馬克斯博士在一份聲明中說：「今天的批準代表著一個重要的機會，可以幫助在更大的年齡範圍內的人預防與HPV相關的疾病和癌症。」根據美國疾病控制和預防中心的數據，馬克斯說：「在接種疫苗所涵蓋的HPV類型之前，接種HPV疫苗有可能預防90%以上的這些癌症，即每年31，200例。」
According to the CDC, about 80 million Americans are infected with some type of human papillomavirus; an additional 14 million are newly infected each year. In fact, the CDC says, HPV infections are "so common that nearly all men and women will get at least one type of HPV at some point in their lives."
根據疾控中心的數據，大約有8000萬美國人感染了某種類型的人類乳頭瘤病毒；每年又有1400萬人感染了這種病毒。事實上，疾控中心說，HPV感染「非常普遍，以至於幾乎所有的男性和女性在他們的生活中都會感染至少一種HPV病毒。」
Most HPV infections go away on their own, but some remain and can cause cervix, vagina and vulva cancer in women; penis cancer in men; and genital warts, anal cancer and head and neck cancers in both sexes. There are 150 viruses that make up HPV, but most are rare.
大多數HPV感染自行消失，但有些人乳頭瘤病毒感染仍然存在，並可能導致婦女的子宮頸癌、陰道癌和外陰癌；男性的陰莖癌；以及男女兩性的生殖器疣、肛門癌和頭頸部癌症。構成HPV的病毒有150種，但大多數是罕見的。
Gardasil 9 protects against the nine types of HPV that are responsible for the majority of HPV-related diseases (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58). Gardasil 9 was approved by the FDA in 2014; an older version of the vaccine covered only four types and is no longer distributed in the United States, the agency said.
九價加衛苗可防止引起大多數HPV相關疾病的9種(6、11、16、18、31、33、45、52和58型)。FDA在2014年批準了加衛苗疫苗；該機構說，較早版本的疫苗隻覆蓋四種類型，並且不再在美國分發。
Positive study results
實證研究結果
The FDA said it based the expansion on results of a study of 3,200 women followed over 3? years. The study found that Gardasil 9 was 88% effective in the prevention of vulvar, vaginal and cervical precancerous lesions, cervical cancer and genital warts caused by the nine HPV strains.
FDA表示，這項擴張是基於一項對3200名女性進行了為期3年半的研究的結果。研究發現，九價加衛苗在預防HPV引起的外陰、陰道及宮頸癌前病變、宮頸癌和生殖器疣方面的有效率為88%。
The effectiveness of the vaccine in men was "inferred" from the data on women as well as a clinical trial of 150 men ages 27 to 45 who received a three-dose vaccination regimen over a six-month period. The FDA also looked at data from studies of younger men, ages 16 to 26.
從關於女性的數據以及對150名年齡在27至45歲之間的男性進行的臨床試驗中可以推斷出這種疫苗在男性身上的有效性，他們接受了為期6個月的三劑量疫苗接種方案。FDA還調查了年齡在16到26歲的年輕男性的研究數據。
The overall safety of Gardasil 9, the FDA said, was evaluated in 13,000 men and women. Common adverse reactions included swelling, redness and pain at the injection site, and headache.
FDA稱，九價加衛苗的總體安全性被13，000名男性和女性評估。常見的不良反應包括注射部位腫脹、發紅、疼痛和頭痛。
Insurance coverage expected
預期在保險範圍內
"This is exciting news," said Dr. Charles Leath, a gynecologic oncology specialist at the University of Alabama at Birmingham. "We do have a group of individuals over the age of 26 who can certainly benefit from the protection this vaccine provides and have had to pay out of pocket for that protection."
「這是令人興奮的消息，」伯明翰阿拉巴馬大學婦科腫瘤學專家查爾斯·萊斯博士說。「我們確實有一群26歲以上的人，他們肯定能從這種疫苗提供的保護中受益，他們不得不自費接收疫苗保護。
Typically, Leath said, insurance companies cover only recommended vaccines. That means that adults who feel they may benefit from Gardasil 9"s protection had to pay out of pocket for "off-label" use. Out-of-pocket cost for a three-dose vaccination series of Gardasil 9 ranges between $400 and $500.
萊斯說，通常情況下，保險公司只為推薦的疫苗提供保險。這意味著，那些覺得自己可能從加加衛苗的保護中受益的成年人，不得不自掏腰包購買在保險範圍外的疫苗。九價加衛苗系列三劑疫苗的費用在400到500美元之間.
The FDA approval, Leath said, should clear the way for insurance companies to cover the cost of the vaccine.
萊斯說，FDA的批準為保險公司支付疫苗的成本掃清了路線。
"In general, what we"ve seen is that once the FDA gives approval and says there is a good response to the vaccine, we would in short order expect approved coverage from insurers," Leath said.
萊思說：「總的來說，我們看到的是，一旦FDA批準了疫苗，並且說疫苗有了很好的反應，我們將在短期內期待保險公司的批準承保範圍。」
Because HPV is so widespread, many health professionals have thought that extending the protection to adults would not be worthwhile. But others point out that a person may not get every type of HPV that is covered by the vaccine or might have a life situation that has offered them protection.
由於HPV是如此廣泛，許多衛生專業人士認為，擴大對成年人的保護將是不值得的。但另一些人指出，一個人可能不會感染疫苗覆蓋的每一種類型的人乳頭狀瘤病毒，或者可能有一種為他們提供保護的生活狀況。
Leath used the example of a woman in a years-long monogamous marriage who becomes a widow in her 50s.
萊思舉了一個例子，一個女人在一夫一妻製的婚姻中，50多歲就成了寡婦。
"We see individuals where, their spouse dies, they get a new partner, and they were never able to get vaccinated before," Leath said. "I think we should look at each individual scenario and discuss the options with the patient."
「我們看到的個人，他們的配偶死了，他們找到了一個新的伴侶，他們從來沒有能夠得到疫苗的保護，」萊思說。「我認為我們應該考慮每一種情況，並與病人討論各種選擇。」
Current CDC recommendations
目前疾控中心的建議
Current recommendations by the CDC, which were in place before Friday"s FDA announcement, call for HPV vaccinations for boys and girls to begin between the ages of 11 and 12; the regimen can occur as early as age 9.
美國疾病預防控制中心目前的建議在美國食品和藥物管理局宣布之前就已經頒布，它呼籲男孩和女孩在11歲至12歲之間開始接種HPV疫苗；這種方案最早可以在9歲開始實施。
If it is begun before age 15, boys and girls get two doses of HPV vaccine; the second vaccination should be given six to 12 months after the first dose.
如果在15歲之前開始接種，男孩和女孩就會接種兩劑HPV疫苗；第二次接種應在第一次接種後6至12個月進行。
If it"s not given by then, the CDC recommends girls ages 15 to 26 and boys ages 15 to 21 receive three doses; the last two should be given one or two and then six months after the first.
如果到那時還沒有注射，疾控中心建議15至26歲的女孩和15至21歲的男孩打三針；最後兩劑應該在第一次注射後一到兩個月，然後六個月後再接種一次。
Gay, bisexual and other men who have sex with men, transgender individuals and immunocompromised persons (including those with HIV infection) up to age 26 should also receive the vaccine regimen, according to CDC recommendations.
根據美國疾病預防控制中心的建議，男同性戀者、雙性戀者和其他男性行為者、變性者和免疫缺陷者(包括愛滋病毒感染者)也應該接受疫苗治療。
世界播，天下大事全掌握！ 中英雙語呈現，還可以加強英語學習哦！ 這事你怎麼看？歡迎留言探討
香港九龍灣馬來街興發大廈15樓D室