New Vaccines

• Hiberix®

On August 19, 2009, the U.S. Food and Drug Administration (FDA) licensed Hiberix® for use in young children as the Hib booster (final) dose for children 15 months through 4 years of age who have previously received the primary Hib vaccination series.  Hiberix® is a Haemophilus influenzae type b conjugate (tetanus toxoid conjugate) vaccine. The Advisory Committee on Immunization Practices (ACIP) recommends Hib booster vaccination for children at ages 12 through 15 months. Hiberix® (Hib conjugate vaccine) is now available from VFC in California. 

• Cervarix®

On October 15, 2009, the FDA approved Cervarix®, a new HPV vaccine to prevent cervical cancer and precancerous lesions caused by HPV types 16 and 18. The vaccine was licensed for females ages 10 years through 25 years. 

The ACIP voted for inclusion of Cervarix® in the VFC program for girls 9 years through 18 years.  The ACIP harmonized the recommendations for Gardasil® and Cervarix®. Cervarix® will be recommended for girls at 11 - 12 years and catch-up vaccination through age 26 years; both vaccines may be given as young as age 9 years. Cervarix® is administered as a three-dose series. 
Both vaccines are recommended to be given on a harmonized schedule; the initial dose is recommended to be followed by two additional doses.  The second dose is recommended at 1 to 2 months after the first dose and the third dose at 6 months after the first dose. VFC providers will be notified when the vaccine is available in the California VFC program.

New Indication

• Gardasil®

The FDA recently approved a new indication for Gardasil® to prevent genital warts in men and boys ages 9-26 years. The ACIP voted for permissive use of Gardasil® in men and boys, although not as a full recommendation for routine use. The committee voted for inclusion of Gardasil™ in the VFC Program for males 9-18 years.