Merck & Co Inc. has filed a Biologics License Application for Proquad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] with the US FDA.
Proquad is an investigational vaccine for simultaneous vaccination against measles, mumps, rubella and varicella in children 12 months to 12 years of age. Proquad combines two established Merck vaccines, M-M-R II (Measles, Mumps, Rubella Virus Vaccine Live) and Varivax [Varicella (Oka/Merck) Virus Vaccine Live].
Merck submitted the application for Proquad to the FDA on Aug. 31 and received notification of the FDA's acceptance of the application this week. Merck anticipates an FDA action on the application by early July, based on a standard 10 to12-month FDA review.
M-M-R II is indicated for simultaneous vaccination against measles, mumps and rubella in individuals 12 months of age or older. The Advisory Committee on Immunization Practices (ACIP) recommends administration of the first dose of M-M-R II at 12 to 15 months of age and administration of the second dose of M-M-R II at four to six years of age. Varivax is indicated for vaccination against varicella in individuals 12 months of age and older.