WHAT:

Merck officials and cervical cancer experts worldwide are touting Gardisil, the first-ever vaccine against human papillomavirus, as the biggest breakthrough in preventing cervical cancer since the Pap smear. Gardisil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) is currently under review by the U.S. Food and Drug Administration. FDA advisers were expected to decide late today whether to recommend FDA approval for the vaccine. The FDA isn’t required to follow the advice of its expert panels, but usually does. A decision on approval by the FDA is expected by June 8.

WHO:

Sharmila Makhija, M.D., gynecologic oncologist at the University of Alabama at Birmingham (UAB), was a principle investigator on both the Merck FUTURE III study looking at the vaccine's efficacy in women 24 to 45 years old and a co-investigator on Merck's FUTURE II study, examining the vaccine's efficacy in 16- to 23-year-old women. She also is a co-investigator on Glaxosmithkline’s (GSK) HPV vaccine trials, which she says are expected to be ready for FDA approval this fall.

Among other honors, Dr. Makhija serves on the editorial boards for the International Journal of Gynecological Cancer and Women's Oncology Review. She received her medical degree from UAB, completed a residency in ob-gyn at the University of Louisville Hospital in Kentucky and a fellowship in gynecologic oncology at Memorial Sloan-Kettering Cancer Center in New York.

MORE:

“If FDA approved, the Merck HPV vaccine would be the first vaccine that could prevent women from developing an HPV infection, which is felt to be the cause of most cervical cancers. This could potentially prevent hundreds of thousands of women worldwide from dying from cervical cancer,” she said. Worldwide, approximately 450,000 women are diagnosed with cervical cancer annually, resulting in more than 200,000 deaths. In the U.S., approximately 12,000 women are diagnosed with cervical cancer, resulting in 4,500 deaths per year.