The new indication is based on data from 3,200 women 27 - 45 years old who were followed for 3.5 years after vaccination with Gardasil ®. Gardasil®, which is no longer available, contains only 4 of the HPV strains in Gardasil 9. Yet it was 88% effective in preventing persistent HPV infection, genital warts, and various precancerous and cancerous lesions related to the HPV strains in the vaccine. Effectiveness for men was inferred from the data for women, a small immunogenicity trial in men, and the experience of younger males.
The CDC’s Advisory Committee on Immunization Practices is expected to review the expanded age range. If it recommends HPV vaccine for the older group, insurance companies will likely cover the cost.
→ FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old