The US Food and Drug Administration has accepted for review the Biologics License Applications (BLAs) of Merck for two investigational vaccines, Rotateq (rotavirus vaccine, live, oral, pentavalent) and Zostavax [zoster vaccine live (Oka/Merck)].

Rotateq is Merck's investigational pentavalent vaccine to protect against rotavirus gastroenteritis. Rotateq is an oral, liquid vaccine that contains five human serotypes: G1, G2, G3, G4 and P1. These five serotypes cause most rotavirus disease worldwide. Merck submitted the application for Rotateq to the FDA on April 5. Merck has also submitted applications for licensure of Rotateq in Australia, the European Union (EU) and Mexico, and plans additional filings later this year in Canada and in countries in Asia and Latin America, a release said here.

Zostavax is Merck's investigational vaccine for the prevention of herpes zoster, commonly known as "shingles;" prevention of postherpetic neuralgia (PHN), the persistent, long-term nerve pain that is the most common complication of shingles; and the reduction of acute and chronic shingles-associated pain in adults. Merck submitted the application for Zostavax to the FDA on April 25. Merck has submitted an application for licensure of Zostavax in the EU, and plans additional filings later this year in Australia, Canada and in countries in Asia and Latin America.

Merck's BLA for Proquad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] is under review by the FDA. Proquad is Merck's investigational vaccine for simultaneous vaccination against measles, mumps, rubella and varicella.

Merck remains on track to submit a BLA to the FDA for Gardasil, the company's investigational HPV and cervical cancer vaccine, in the second half of this year, release added.