ADVISORY PANEL WILL REVIEW MERCK VACCINES
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.