The FDA has accepted for review two license applications for Merck & Co's investigational vaccines, Rotateq and Zostavax, to protect against rotavirus gastroenteritis and herpes zoster respectively.
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Rotateq is an oral liquid vaccine that contains five human serotypes which cause most rotavirus disease worldwide. Zostavax is Merck’s investigational vaccine for the prevention of herpes zoster or shingles. Merck submitted applications for both drugs during April this year.
Additional applications have been submitted for both vaccines in Europe. Rotateq also has applications pending in Australia and Mexico while further submissions are planned for both treatments.
Merck has another application currently under review at the FDA for its Proquad vaccine aimed at the simultaneous treatment of measles, mumps, rubella and varicella.
Merck remains on track to submit an application for Gardasil, the company’s investigational HPV and cervical cancer vaccine, in the second half of this year.