FDA Has Approved Gardasil Use For Adults Up To 45-Years-Old

FDA Has Approved Gardasil Use For Adults Up To 45-Years-Old

Up until now, the drug Gar­dasil was only approved for teenagers and young adults. How­ev­er, the FDA recent­ly changed that with its approval of Gar­dasil 9, a sup­ple­men­tal appli­ca­tion that allows indi­vid­u­als – men and women between 27 and 45 years of age – to get the drug.

Dr. Peter Marks, FDA’s Cen­ter for Bio­log­ics Eval­u­a­tion and Research direc­tor, said the approval is an acknowl­edg­ment to help pre­vent can­cers and oth­er HPV-relat­ed dis­eases in old­er adults. 

Accord­ing to the CDC, HPV vac­ci­na­tion can help pre­vent over 90 per­cent of the can­cers asso­ci­at­ed with the STD. This trans­lates to 31,200 cas­es each year from being devel­oped. The CDC esti­mates that 14 mil­lion Amer­i­cans are infect­ed with HPV annu­al­ly. 12,000 women with HPV devel­op cer­vi­cal can­cer, with about 4,000 of those women dying from that disease.

Both men and women can devel­op var­i­ous types of can­cer because of HPV.

The FDA first approved Gar­dasil in 2009 to stop cer­tain HPV-can­cers and dis­ease, but is no longer being used in the U.S. The agency approved the use of Gar­dasil 9 in 2014, cov­er­ing nine kinds of HPV and was ini­tial­ly approved for per­son nine to 26-years-old.

After study­ing a group of 3,200 women between 27 and 45 years of age, the agency not­ed Gar­dasil 9 was 88 per­cent effec­tive in stop­ping the devel­op­ment of gen­i­tal warts, vagi­nal pre­can­cer­ous lesions, cer­vi­cal can­cer, etc. The FDA said its approval of the drug for this age group is based on the study conducted.

The most com­mon side effect of the Gar­dasil 9 drug is swelling and red­ness at the shot site and headaches.


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