The Food and Drug Administration (FDA) has approved Priorix (measles, mumps and rubella vaccine, live) for active immunization for the prevention of measles, mumps and rubella in individuals 12 months of age and older.
Priorix is administered as a 2-dose series (each dose is approximately 0.5mL) via subcutaneous injection. The first dose is administered at 12 to 15 months of age; the second dose at 4 to 6 years of age. The vaccine may also be administered as a second dose to individuals who have received the first dose of another MMR-containing vaccine.
The approval was based on safety data from 6 clinical studies that assessed Priorix in a total of 12,151 participants, of which 8780 were between 12 to 15 months of age, 2917 were between 4 to 6 years of age, and 454 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 local reactions (pain, swelling, redness) and systemic reactions (irritability, loss of appetite, drowsiness, fever).
Priorix is supplied in a box containing 10 single-dose vials of lyophilized antigen component and 10 single-dose prefilled ungraduated syringes of sterile water diluent. After reconstitution, each vial contains 1 dose (approximately 0.5mL) of Priorix.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization,” said Temi Folaranmi, MD, Vice President and Vaccines Therapeutic Area Head, US Medical Affairs, GSK. “Making Priorix available to patients in the US will ensure health care professionals have more than one option for this critical vaccine as they work to catch their patients up on recommended vaccinations.”
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is scheduled to consider the formal inclusion of Priorix into the vaccine schedule and recommendations in a June meeting.
- GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older. News release. GlaxoSmithKline plc. Accessed June 6, 2022. https://www.businesswire.com/news/home/20220606005681/en/GSK-announces-US-FDA-approval-of-PRIORIX-for-the-prevention-of-measles-mumps-and-rubella-in-individuals-12-months-of-age-and-older
- Priorix. Package Insert. GlaxoSmithKline plc; 2022. Accessed June 6, 2022. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Priorix/pdf/PRIORIX.PDF
Source: Medical Bag https://www.medicalbag.com/home/news/fda-approves-additional-option-for-measles-mumps-and-rubella-vaccination-2/