The FDA approved the expanded use of GARDASIL-9: a recombinant vaccine, against nine types of Human papillomaviruses for men and women aged 27 to 45 years on the 5th of October 2018. The approval was based on new research and long-term follow-up data from about 13,000 subjects. “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.
According to the Center for Disease Control (CDC), every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with HPV of which about 4,000 women die from cervical cancer. The Center for Disease Control and Prevention has stated: “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.”
The vaccine was developed in 2006 against 4 types of HPV and was approved by the FDA in 2014. At first, the vaccine was approved for males and females 9 to 26 years old, for the prevention of genital warts and cancer. Keep in mind though that it does not prevent all types of HPV-associated cancers but only those caused by HPV Types 6/11/16/18/31/33/45/52/58. GARDASIL-9 is administered in the muscles of the upper arm. The whole HPV vaccination program comprises of 3 doses at (0, 2 months, 6 months).
HPV is the most common sexually transmitted viral infection. It leads to recurrent respiratory papillomatosis (hence the name): warts in the throat, genital warts, cervical cancer, etc. Cancer caused by HPV often doesn’t show symptoms until in its later stages. With the approval of GARDASIL-9, many HPV-associated conditions can be effectively prevented.
The Food and Drug Administration approved the first DNA test for HPV in 2014. Women should have their first Pap smear, at the age of 21 and be tested for HPV at the same time, regardless of the onset of sexual activity. After that, women 21 to 29 years of age should have just a Pap test every three years, and women aged 30 to 65 should be screened every five years. Regular testing and vaccination can eradicate many types of Human papillomavirus-associated cancers.
The FDA, an agency of The US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, cosmetics, food, medical devices, etc.