Merck Proquad MMR/V Combo Vaccine Clears FDA With Approval For Second Round MMR Vaccination
This article was originally published in The Pink Sheet Daily
Executive Summary
The measles, mumps, rubella and varicella vaccine will be priced at $120.25 for an individual single-dose vial.
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Merck has begun taking orders for its measles, mumps, rubella and varicella vaccine Proquad and expects to commence shipping the newly approved vaccine in a few weeks. Proquad's biologics license application for the quadrivalent vaccine was approved Sept. 6 for use in children ages 12 months to 12 years. It was also cleared for use as a second dose of measles, mumps and rubella vaccine in the same patient group. The firm submitted the BLA in August 2004; FDA extended its review date to Sept. 30 to allow for additional time to review process validation data (1 (Also see "ProQuad Vaccine BLA Review Extended To September" - Pink Sheet, 21 Jul, 2005.)). Labeling notes that although Merck has not performed formal studies to evaluate the clinical efficacy of Proquad, efficacy of the vaccine components was established in clinical studies of the monovalent vaccines. Merck reported that four randomized trials of 5,446 children ages 12 months to 23 months demonstrated vaccine response rates for Proquad were similar to those for concomitant administration of the separate vaccines. According to the firm, the catalog price for Proquad will be $114.61 per dose when purchased as a pack of 10 single-dose vials or $120.25 if purchased as an individual single-dose vial. The firm previously said that it would be sensitive to cost concerns when pricing the vaccine. While Merck will focus its vaccine sales and marketing efforts on Proquad, the firm's M-M-R II (measles, mumps and rubella) and Varivax (varicella) vaccines will continue to be marketed for individual use. Merck's competition for Proquad will be from individual vaccines in the near-term. GlaxoSmithKline does not plan to pursue U.S. registration of its MMR/V combination Priorix-Tetra . Proquad is the first of four major vaccines in Merck's pipeline to earn FDA approval. The firm expects approval for its rotavirus vaccine Rotateq and herpes zoster vaccine Zostavax in April 2006, with a BLA submission by year-end for its human papillomavirus vaccine Gardasil . Merck said it plans to move additional sales reps to the vaccines segment as its BLAs are approved. The Centers for Disease Control & Prevention Advisory Committee on Immunization Practices is expected to make recommendations for Proquad at a meeting in October. - Kathleen Michael |