GSK Will No Longer Supply HPV Vaccine in U.S.
Cervarix is a vaccine indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18:
- Cervical cancer
- Cervical intraepithelial neoplasia Grade 2 or worse and adenocarcinoma in situ, and
- Cervical intraepithelial neoplasia Grade 1
The vaccine is approved for use in females 9–25 years of age.
The company announced their decision to stop supplying the vaccine back in August 2016 due to very low market demand.
In a statement to FiercePharma, a spokesperson for GSK said, "With another HPV vaccine available in the U.S., patients will continue to have an option to help prevent HPV infection. Our license with the FDA is still in effect and the vaccine has 107 regulatory approvals covering 136 markets internationally."
Two other HPV vaccines that are currently available include Gardasil (HPV Quadrivalent [types 6, 11, 16, and 18) and Gardasil 9 (HPV 9-valent vaccine [recombinant], both from Merck. In addition to being approved for girls and women (9–26 years of age), Gardasil and Gardasil 9 are indicated for use in boys and men 9 through 26 years of age to prevent anal cancer, genital warts, and anal intraepithelial neoplasia Grades 1, 2, and 3 caused by specific HPV types.
The Food and Drug Administration (FDA) also recently approved a supplemental Biologics License Application (sBLA) for Gardasil 9 to include a 2-dose regimen for individuals aged 9 to 14 years.
For more information on Gardasil and Gardasil 9 visit Merck.com.