Washington, Oct 7 (IANS) The US Food and Drug Administration (FDA) has approved the use of Human Papillomavirus (HPV) vaccine, which prevents cervical cancer and other malignancies, for men and women aged 27-45 years.
The vaccine Gardasil 9 covers nine HPV types that is responsible for certain cancers and diseases. It was earlier approved for use in males and females aged 9 through 26 years.
According to the FDA, Gardasil was 88 per cent 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.
The “approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
“The Center for Disease Control and Prevention (CDC) has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 per cent of these cancers, or 31,200 cases every year, from ever developing,” he added.
In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types.
The new approval was based on the results of a study in approximately 3,200 women aged 27 through 45 years of age, followed for an average of 3.5 years.
The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.
The FDA has granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co.