On October 5, the US Food and Drug Administration (FDA) approved a supplemental application for the nine-valent HPV vaccine (Gardasil 9) for vaccination for women aged 27-45 and male adults. Prior to this, the nine-valent HPV vaccine was suitable for women aged 9-26 or male adolescents and adults.
According to the US Centers for Disease Control and Prevention, 140 million Americans are infected with HPV every year; about 12,000 women are diagnosed with cervical cancer, and about 4,000 women die of cervical cancer. In addition, the HPV virus is associated with some other forms of cancer that may infect men and women.
Gardasil (4-valent HPV vaccine) was first approved by the FDA in June 2006. In December 2014, the FDA approved the Merck’s nine-valent HPV vaccine (Gardasil 9) to prevent cervical cancer, vulvar cancer, vaginal cancer and anus caused by HPV types 16, 18, 31, 33, 45, 52 and 58. Cancer, as well as genital warts caused by HPV types 6 and 11.
Gardasil is preventing HPV infection, condyloma acuminata, vaginal precancerous lesions, cervix in a large clinical trial of 3,200 women aged 27-45 years with a mean follow-up of 3.5 years The efficacy at the composite endpoint of precancerous lesions, cervical cancer associated with HPV infection was 88%. The FDA’s approval of Gardasil 9 for the 27-45 year old population is also based on the results of the above study and longer-term follow-up data for this study.
At present, bivalent, tetravalent, and nine-valent cervical cancer vaccines have been approved in China. Among them, the scope of application of the bivalent cervical cancer vaccine is 9-45 years old, the fourth price is suitable for women aged 20-45, and the nine price is suitable for women aged 16-26. The HPV vaccine has not been approved for use in the male population in China.
Which is the second-, fourth-, and nine-valent HPV vaccine?
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