The Food and Drug Administration has provided a boost to both Merck & Co and to adults looking to prevent human papillomavirus (HPV) infection, extending approval of the Gardasil 9 vaccine to cover people between the ages of 27 and 45 years.
In a large study of approximately 3200 women aged 27 through 45 who were given Gardasil and followed for an average of 3.5 years, the vaccine 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.
"Today's approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range", said Peter Marks, the director of the Center for Biologics Evaluation and Research.
The Centers for Disease Control and Prevention estimates about 14 million people become newly infected with HPV each year, mostly teens and young adults. This vaccine protects against nine such strains, including those that have most chances of causing cancer and even genital warts.
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The vaccines effectiveness in men ages 27 to 45 is inferred from the data in women, from its efficacy in younger men and from evidence that it created immunity in a study of men 27 to 45-years-old.
Using these results, the FDA approved the newer formulation - Gardasil 9, which protects against five additional strains - for people ages 27 through 45.
Among the 13,000 males and females evaluated, the most commonly reported adverse events were injection site pain, swelling, redness, and headaches.
Regarding prevention and treatment, Brown recommends the HPV vaccine, widely provided to everyone-regardless of sex, gender, or sexual orientation-before sexual debut, and genital wart treatment.
Let's back up a second: Back in 2006, the FDA approved the first version of Gardasil, which was shown to prevent various cancers and diseases caused by four types of HPV. But data also indicate that the vaccine can benefit the older group.
US regulators Friday expanded the use of Merck's cervical cancer vaccine to adults up to age 45. "At higher risk are people who have had multiple sexual partners in recent years and are still sexually active, or who are sexually active for the first time in many years, perhaps because of a relationship change".
But does the new age approval mean that adults who never got the HPV vaccine should get one now?
For the study, the team investigated almost 600 men who have sex with men, or MSM, and transgender women in Lima, Peru. The recommended dose for those over 26 will be three doses. This year Merck the manufacturers of vaccine requested the expansion of the age range, and FDA granted the application in June.