FDA To Review Merck's V503 HPV Vaccine
By Cyndi Root
Merck announced in a press release that the Food and Drug Administration (FDA) has decided to review its V503 vaccine. Accepted for standard review, the investigational agent is indicated for human papillomavirus (HPV). The V503 vaccine showed positive results in a Phase III clinical study, which Merck relied on to file the application, and which the FDA may have relied on when deciding to review the drug. Study investigator Elmar Joura, M.D., Associate Professor of Gynecology and Obstetrics, Medical University of Vienna and Comprehensive Cancer Center, Vienna, Austria said, “In the Phase III studies being presented for the first time, V503 prevented approximately 97 percent of high-grade cervical, vulvar and vaginal diseases caused by five additional HPV types.”
Human papillomavirus is a sexually transmitted disease with over 40 different strains that can infect both females and males. Some HPV types infect the genitals and some infect the throat and mouth. Some infections are dormant while others become active and cause genital warts. Some strains are more virulent and cause cancer. People having sex, including oral sex, are susceptible to contracting the virus. The Centers for Disease Control (CDC) warns that condoms do not fully protect against HPV. The agency recommends vaccines for boys and girls as young as 11-12 years old. Currently, girls can get Cervarix and Gardasil vaccines and boys can get Gardasil.
V503 HPV Vaccine
The V503 investigational vaccine prevented 97% of HPV strains (types 31, 33, 45, 52, and 58) in the recent Phase III efficacy study. It also showed an immune response equal or greater than the Gardasil vaccine in types 6, 11, 16, and 18. The V503 vaccine was effective for five more types than Gardasil. Investigators found an almost equal amount of adverse events between V503 and Gardasil, however V503 caused a slightly higher incidence of injection site side effects including swelling and pain. Both groups reported mild or moderate pain at the injection site. Reported side effects included headache, nausea, dizziness, fatigue, and fever.
Merck is a globally positioned healthcare company, known as MSD outside the U.S. Its product line includes drugs and biologics. Roger M. Perlmutter, M.D., Ph.D., president of Merck Research Laboratories said, “Our investigational vaccine V503 reduced HPV-associated precancerous lesions in young women.” He added that its success was built on Gardasil’s success and the company maintains an ongoing commitment to research.