FDA is observing a trend toward more vaccines for the adolescent population.

"The pattern here is we are starting to license more vaccines for the adolescent populations," Center for Biologics Evaluation & Research Office of Vaccine Research & Review Director Norman Baylor said at an Advisory Commission on Childhood Vaccines meeting June 1.

Baylor noted that FDA has already licensed two vaccines this year for use in adolescents.

Sanofi-Aventis' meningococcal vaccine Menactra was approved in January for use in patients ages 11 to 55 (¹ Also see "Sanofi-Aventis Eyes Expanded Menactra Indication Following Initial Approval" - Pink Sheet, 18 January, 2005.).

Sen. Rick Santorum (R-Penn.) introduced legislation May 12 that would add meningococcal vaccines to the list of taxable vaccines for purposes of the Vaccine Injury Compensation Trust Fund; the bill has been referred to the Senate Finance Committee.

GlaxoSmithKline's tetanus/diphtheria/acellular pertussis vaccine Boostrix was approved in May for use in patients ages 10 to 18 (² Also see "GSK May Launch Boostrix Vaccine Ahead Of June CDC Recommendation" - Pink Sheet, 3 May, 2005.).

Sanofi's Tdap vaccine Adacel is pending at FDA with a user fee date of June 11; the vaccine's safety and effectiveness were unanimously endorsed by an FDA advisory committee in March (³ Also see "Boostrix, Adacel Tdap Boosters Are Effective, FDA Advisory Committee Says" - Pink Sheet, 16 March, 2005.).

Two Phase III human papilloma virus vaccines are expected to be targeted toward the adolescent population. Merck expects to file a BLA for Gardasil in the second half of 2005, and GSK expects to submit the Cervarix application in 2006 or 2007.

- Brian Marson

Teen Vaccine Approvals Increasing, FDA Says

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