GSK obtains FDA nod for Priorix
GSK has obtained the Food and Drug Administration’s clearance for Priorix (measles, mumps and rubella vaccine, live) for active immunization for the prevention of measles, mumps and rubella in individuals aged 12 months old and older.
“We’re proud to make Priorix available in the U.S. for the first time, adding a choice for providers to help protect patients against these highly contagious diseases and to further strengthen offerings in our pediatric vaccine portfolio,” said Judy Stewart, senior vice president and head of U.S. vaccines at GSK.
Measles, mumps and rubella are acute and highly contagious viral diseases responsible for considerable morbidity and mortality throughout the world. In recent years, measles outbreaks have occurred in the United States and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries, GSK said.
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According to a recent Centers for Disease Control and Prevention report, vaccine ordering in the past two years through the CDC’s Vaccines For Children program, the federal program through which about half of the children in the country are immunized, dropped more than 10%, indicating that fewer vaccinations in children were occurring. The report also noted 400,000 fewer children entered kindergarten in the 2020-2021 school year than expected nationally, meaning those children may not be up to date on childhood immunizations like their MMR vaccination, the company noted.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization. Missed vaccinations during the pandemic makes children even more vulnerable to vaccine-preventable diseases like measles,” said Temi Folaranmi, vice president and vaccines therapeutic area head of U.S. medical affairs at GSK. “Making Priorix available to patients in the U.S. will ensure healthcare professionals have more than one option for this critical vaccine as they work to catch their patients up on recommended vaccinations.”
The CDC recommends people get a MMR vaccine to protect against measles, mumps and rubella. Children should get two doses of MMR vaccine, starting with the first dose at 12 through 15 months of age, and the second dose at 4 through 6 years of age. Teens and adults also should be up to date on their MMR vaccination.
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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.