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GSK plc today announced FDA approval of the PRIORIX vaccine for prevention of measles, mumps, and rubella.
Today, GSK plc announced the US Food and Drug Administration (FDA) approval of PRIORIX (Measles, Mumps and Rubella Vaccine, Live) for the active immunization of the prevention of measles, mumps, and rubella (MMR) in those aged 12 months and older.
Currently, PRIORIX is licensed in more than 100 countries, including all European countries, Canada, Australia, and New Zealand, and more than 800 million doses have been distributed.
Safety was examined for PRIORIX in 6 clinical studies with a total of 12151 participants—6391 in the United States. The participants— 8780 children (4148 in the US), aged 12 through 15 months; 2917 (1950 in the US) 4 to 6 years old; 454 (293 in the US) aged 7 and over; received at least 1 dose of PRIORIX. The most common adverse events reported included pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever. Vaccine efficacy was demonstrated, according to the company, based on immunogenicity data compared to the comparator vaccine.
PRIORIX may be administered as a first dose, followed by a second dose as well. It can also be administered as a second dose to those who have previously received the first dose of another MMR-containing vaccine.
According to the Centers of Disease Control and Prevention (CDC), children getting an MMR vaccine to protect against measles, mumps, and rubella should get 2 doses starting with a first dose at 12 to 15 months and a second dose at age 4 to 6. Adults and teens should also be up to date on their MMR vaccine, according to the press release.
GSK plc announced that PRIORIX is scheduled to be on the agenda for the June CDC Advisory Committee on Immunization Practices “meeting for consideration of formal inclusion into the vaccine schedule and recommendations,” wrote the release.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization [sic]. Missed vaccinations during the pandemic makes children even more vulnerable to vaccine-preventable diseases like measles,” said Temi Folaranmi, MD, vice president and vaccines therapeutic area head, US Medical Affairs, GSK, in the release. “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.”
GSK announces US FDA approval of PRIORIX for the prevention of measles, mumps and rubella in individuals 12 months of age and older. BusinessWire. Press release. Published June 6, 2022. 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