Written by By Kelsey P. Clark , CNN
Members of the U.S. Food and Drug Administration’s Advisory Committee have voted against the approval of a drug known as PREVAIL that is a surrogate measure for efficacy for preventing cervical cancer.
The Protecting Adolescents from Erosion and Streptococcus (PATH) currently keeps more than 30% of young girls in the U.S. from becoming infected with human papillomavirus, or HPV, which causes most cervical cancers.
Despite PREVAIL’s approval in 2016 , the Associated Press says that representatives of 17 states, led by North Carolina, filed a lawsuit with the FDA last month, challenging the decision to approve the vaccine, which has yet to receive a final green light from the FDA.
The organization previously pulled back on the approval of another HPV vaccine, Gardasil, which is required for girls who are students in some U.S. schools.
A spokeswoman for the FDA said Thursday that the agency will review a request for more data from Merck to evaluate the effectiveness of PREVAIL.
An outbreak of 14 cases of HPV and one death tied to the vaccine last month in West Virginia prompted state health officials to recently ban the use of Gardasil on high school campuses.
The National Institutes of Health says more than a quarter of all teenage girls are infected with HPV at some point in their lives. In females, HPV is linked to 94% of cervical cancers and 70% of vaginal, vulvar and anal cancers.
Merck said in a statement that “a 3-year, 80-patient study showed a reduction in HPV infection severity and risk for more than half of evaluable patients. These results suggest an important mechanism for the immunization against HPV which may serve as a basis for future HPV prevention studies, further enhancing the effectiveness of the vaccine.”
