HPV vaccine approved for adults 27 to 45 by FDA
- 6 years ago
WASHINGTON — The U.S. Food and Drug Administration approved the use of a human papillomavirus vaccine for adults age 27 to 45. The vaccine was previously approved for people age 9 to 26.
According to the Centers for Disease Control and Prevention, around 14 million Americans become infected with HPV every year.
According to an FDA press release, Gardasil 9 prevents certain cancers and diseases caused by nine HPV types.
The vaccine protects against Types 6, 11, 16, 18, 31, 33, 45, 52 and 58, which are responsible for a majority of HPV-related diseases.
The FDA said it based its expansion on results from a study of 3,200 women age 27 to 45 that found Gardasil 9 was 88 percent effective in prevention of vulvar, vaginal and cervical precancerous lesions, cervical cancer and genital warts caused by the nine HPV types.
The vaccine's effectiveness in men was "inferred" from the data on women, in addition to a clinical trial of 150 men ages 27 to 45 who took a three-dose vaccination over a six-month period.
According to the FDA, the safety of Gardasil 9 was evaluated in 13,000 men and women. Common adverse reactions included swelling, redness and pain at the injection site and headache.
According to the Centers for Disease Control and Prevention, around 14 million Americans become infected with HPV every year.
According to an FDA press release, Gardasil 9 prevents certain cancers and diseases caused by nine HPV types.
The vaccine protects against Types 6, 11, 16, 18, 31, 33, 45, 52 and 58, which are responsible for a majority of HPV-related diseases.
The FDA said it based its expansion on results from a study of 3,200 women age 27 to 45 that found Gardasil 9 was 88 percent effective in prevention of vulvar, vaginal and cervical precancerous lesions, cervical cancer and genital warts caused by the nine HPV types.
The vaccine's effectiveness in men was "inferred" from the data on women, in addition to a clinical trial of 150 men ages 27 to 45 who took a three-dose vaccination over a six-month period.
According to the FDA, the safety of Gardasil 9 was evaluated in 13,000 men and women. Common adverse reactions included swelling, redness and pain at the injection site and headache.