FDA approvals
December 10, 2014
The FDA today approved a new vaccine for the prevention of certain diseases caused by HPV that has the potential to prevent approximately 90% of anal, cervical, vaginal and vulvar cancers.
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The recombinant HPV 9-valent vaccine (Gardasil 9, Merck) covers nine HPV types, which is five more than the quadrivalent HPV vaccine (Gardasil).
The vaccine is indicated for females aged 9 to 26 years and males aged 9 to 15 years, and for cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58 and for the prevention of genital warts caused by HPV types 6 or 11.
The additional five types of HPV that Gardasil 9 adds protection against (31, 33, 45, 52 and 58) are the cause of approximately 20% of cervical cancers and are not covered in previous FDA-approved HPV vaccines.
“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “The approval of Gardasil 9 provides broader protection against HPV-related cancers.”
Karen Midthun, MD
Karen Midthun
A randomized controlled international study was conducted using a cohort of approximately 14,000 females (median age, 21 years) who tested negative for vaccine HPV types at the start of the study. Patients were randomly assigned Gardasil 9 or Gardasil.
Gardasil 9 was found to be 97% effective in preventing cervical, vulvar and vaginal cancers caused by the additional HPV types.
In addition, Gardasil 9 was equally as effective as Gardasil in the prevention in the four other HPV types (6, 11, 16 and 18).
There is a low incidence of anal cancer caused by the five additional HPV types. As such, the preventive analysis is based on Gardasil’s demonstrated effectiveness of 78% and additional data on antibodies in males and females who received Gardasil 9.
For children aged 9 to 15 years, the effectiveness of Gardasil 9 was identified in studies that measured antibody response to the vaccine. The study group consisted of approximately 1,200 males and 2,800 females. Their response was similar to participants aged 16 to 26 years. Therefore, the vaccine is expected to have similar effectiveness in the younger age group.
Gardasil 9 is administered as three separate vaccinations, with the initial dose followed by additional vaccinations 2 to 6 months later.
Indications are that patients vaccinated before becoming infected with the HPV strains would benefit the most from Gardasil 9.
The safety of the agent was evaluated in approximately 13,000 males and females, and the most common adverse effects were pain at the injection site, swelling, redness and headaches.
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