FDAnews Drug Daily Bulletin


Dec. 6, 2005

Merck's investigational rotavirus vaccine Rotateq and herpes zoster vaccine Zostavax will be reviewed in December by the FDA's Vaccines and Related Biological Products Advisory Committee.

Merck submitted a biologics licensing application (BLA) for Rotateq on April 5 seeking permission to market the product as a vaccine for rotavirus gastroenteritis, which causes approximately one-third of diarrhea-associated hospitalizations in developing countries and nearly half a million deaths worldwide every year in children 5 years old and younger.

Rotateq is an oral, liquid vaccine that contains five human serotypes — G1, G2, G3, G4 and P1 — known to cause most rotavirus disease worldwide.

Merck submitted a BLA for Zostavax on April 25. The firm is seeking approval of the vaccine to prevent herpes zoster, commonly known as "shingles." The drug is designed to prevent postherpetic neuralgia, the persistent, long-term nerve pain that is the most common complication of shingles.

The Vaccines and Related Biological Products Advisory Committee will discuss Rotateq on Dec. 14 and Zostavax on Dec. 15.