Priority review of Merck's biologics license application for its human papillomavirus vaccine Gardasil could allow the firm to launch before the 2006 back-to-school vaccination season.

Merck submitted the BLA for the recombinant vaccine Dec. 1 and requested a six-month priority review, the firm announced Dec. 5. The estimated user fee date would be June 1.

Gardasil would become one of several vaccines recently approved for use in teenagers, including GlaxoSmithKline's tetanus/diphtheria/acellular pertussis vaccine Boostrix , approved in May for patients ages 10 to 18 (¹ Also see "Teen Vaccine Approvals Increasing, FDA Says" - Pink Sheet, 2 June, 2005.).

Phase III data from Gardasil's clinical trial, which enrolled patients ages 16 through 26, demonstrated 100% efficacy in preventing cervical cancer (² Also see "Merck HPV Vaccine Gardasil Shows 100% Efficacy In Phase III Primary Analysis" - Pink Sheet, 6 October, 2005.).

The product may need to clear cultural as well as clinical hurdles in order to gain wide-scale uptake. If approved, Gardasil will be reviewed by the Centers for Disease Control & Prevention's Advisory Committee on Immunization Practices, which will likely discuss societal issues regarding vaccination of adolescents for a sexually transmitted disease.

A letter sent from Sen. Hillary Clinton (D-N.Y.) to HHS Secretary Michael Leavitt in November encouraged a purely scientific review of HPV vaccine applications, given possible resistance from groups who argue that the vaccine would promote sexual activity among youth (³ Also see "Plan B Lessons Learned? HPV Vaccine Review Should Hinge On Science, Not Politics, Sen. Clinton Says" - Pink Sheet, 17 November, 2005.).

Merck also has BLAs pending for its rotavirus gastroenteritis vaccine Rotateq and zoster virus vaccine Zostavax , which will be reviewed by FDA's Vaccines & Related Biological Products Advisory Committee at its Dec. 14-15 meeting. [Editor's note: To ⁴ watch a webcast or order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]

-Kathleen Michael

Merck Takes A Shot At A June Approval For HPV Vaccine Gardasil

More from Archive

More from Pink Sheet