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美国疾控中心对HPV疫苗接种的建议
 
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美国疾控中心对HPV疫苗接种的建议  

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mgrenmaix
(@mgchanworld)
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已加入: 2年 前
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01/08/2020 5:06 上午  

美国疾控中心对HPV疫苗接种的建议

详细内容见英文链接和英文文章。

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建议

Children and adults aged 9 through 26 years. HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.

9-26岁的孩子和成人。通常建议在11或12岁接种HPV疫苗;接种疫苗也可以在9岁开始。对所有26岁以及26岁以下没有足够接种疫苗的人,建议接种追赶HPV疫苗。

Adults aged >26 years. Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. (Box). HPV vaccines are not licensed for use in adults aged >45 years.

对所有大于26岁的成人不建议接种追赶HPV疫苗。反而对某些没有足够接种疫苗的27-45岁的成人,建议就HPV疫苗接种的临床决策制定得到分享【您与您的医生讨论】。

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https://www.cdc.gov/mmwr/volumes/68/wr/mm6832a3.htm#:~:text=this%20age%20range.-,Recommendations,who%20are%20not%20adequately%20vaccinated.

Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices

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Recommendations

Children and adults aged 9 through 26 years. HPV vaccination is routinely recommended at age 11 or 12 years; vaccination can be given starting at age 9 years. Catch-up HPV vaccination is recommended for all persons through age 26 years who are not adequately vaccinated.

Adults aged >26 years. Catch-up HPV vaccination is not recommended for all adults aged >26 years. Instead, shared clinical decision-making regarding HPV vaccination is recommended for some adults aged 27 through 45 years who are not adequately vaccinated. (Box). HPV vaccines are not licensed for use in adults aged >45 years.

Administration. Dosing schedules, intervals, and definitions of persons considered adequately vaccinated have not changed (3). No prevaccination testing (e.g., Pap or HPV testing) is recommended to establish the appropriateness of HPV vaccination.

Cervical cancer screening. Cervical cancer screening guidelines and recommendations should be followed (17).

Special populations and medical conditions. These recommendations for children and adults aged 9 through 26 years and for adults aged >26 years apply to all persons, regardless of behavioral or medical risk factors for HPV infection or disease.§ For persons who are pregnant, HPV vaccination should be delayed until after pregnancy; however, pregnancy testing is not needed before vaccination. Persons who are breastfeeding or lactating can receive HPV vaccine. Recommendations regarding HPV vaccination during pregnancy or lactation have not changed (1).

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mgrenmaix
(@mgchanworld)
会员 Admin
已加入: 2年 前
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01/08/2020 5:20 上午  

美国默克公司的九价HPV疫苗 (Gardasil 9)2018年10月获得FDA批准

4价和9价则都是进口的默沙东(默克)生产的,一个叫佳达修(Gardasil),一个叫佳达修9(Gardasil 9)。

 


FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old 

 

October 05, 2018

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that 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.”

According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed 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 lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.
 
The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 


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mgrenmaix
(@mgchanworld)
会员 Admin
已加入: 2年 前
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01/08/2020 5:52 上午  

知乎上的科普贴:

https://zhuanlan.zhihu.com/p/138399336


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【Renmaix.com】2018.06.06-2018.09.30-RM