Given as two doses, the vaccine can also be administered as a second shot in individuals who previously received the first dose of another MMR-containing vaccine
GSK gets FDA approval for Priorix. (Credit: Sam Moghadam Khamseh on Unsplash)
GSK has secured the US Food and Drug Administration (FDA) approval for Priorix, its vaccine for the prevention of measles, mumps and rubella (MMR) in individuals aged one year and above.
Priorix is currently licenced in more than 100 countries across the world, including all the European countries, Canada, Australia and New Zealand.
Given as two doses, the vaccine can also be administered as a second shot in individuals who previously received the first dose of another MMR-containing vaccine.
The first dose is administered in children aged 12 to 15 months of age, and the second dose in those aged four to six years, said the British drugmaker.
GSK US Vaccines head and senior vice president Judy Stewart said: “We’re proud to make Priorix available in the US 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 paediatric vaccine portfolio.”
The safety of Priorix was evaluated in six clinical studies, in which a total of 12,151 participants received at least one dose of the vaccine.
The total participants included 8,780 children aged 12 to 15 months, 2,917 kids aged four to six years, and 454 adults and children aged seven years and above.
The most commonly reported adverse reactions include pain, redness, swelling, loss of appetite, irritability, drowsiness and fever.
GSK has determined the efficacy of Priorix based on a comparison of the immunogenicity data to a comparator vaccine.
Furthermore, CDC Advisory Committee on Immunization Practices (ACIP) will consider Priorix for formal inclusion in the vaccine schedule and recommendations.
GSK US medical affairs vice president and vaccines therapeutic area head Temi Folaranmi said: “Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunisation.
“Missed vaccinations during the pandemic make children even more vulnerable to vaccine-preventable diseases like measles.
“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 recently announced its plans to spin off its consumer health business and shift its focus towards vaccines and prescription drugs.