A Biologics License Application (BLA) has been submitted to the Food and Drug Administration (FDA) for Priorix (measles, mumps, and rubella virus vaccine, live) for active immunization against infection by measles, mumps and rubella (MMR).
The BLA submission is supported by safety data from 6 clinical studies that assessed Priorix in a total of 17,393 participants, of which 12,475 were between 12 to 15 months of age, 4007 were between 4 to 6 years of age, and 911 were 7 years of age and older. In the clinical studies, participants received at least 1 dose of either Priorix or a US-licensed MMR virus vaccine, live (M-M-R® II). Efficacy was demonstrated based on comparative immunogenicity data with M-M-R II.
The most common adverse reactions reported with Priorix were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return in the absence of widespread immunization,” said Barbara Howe, MD, Vice President and Director, Vaccines Medical and Clinical, US at GSK. “This submission brings us one step closer to making Priorix available to the patients in the US and ensuring that health care professionals will have more than one option for this important disease prevention tool.”
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends children receive a 2-dose series of the MMR vaccine. The first dose should be administered at 12 to 15 months of age, and the second dose at 4 to 6 years of age. Teens and adults should also be up to date on their MMR vaccination.
GSK files for licensure of MMR vaccine in the US. News release. GlaxoSmithKline. Accessed August 3, 2021. https://www.prnewswire.com/news-releases/gsk-files-for-licensure-of-mmr-vaccine-in-the-us-301346189.html.