FDA approves GSK's MMR vaccine, the first new green light in more than half a century
GSK is bringing one of its widely-licensed vaccines to the US, giving pediatricians a new option for a common childhood shot for the first time in more than 50 years.
The FDA approved GSK’s measles, mumps and rubella vaccine for individuals 12 months and older, the company announced Monday morning. Branded as Priorix, the shot had already been licensed in more than 100 other countries before coming to the US.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization,” GSK’s US vaccines affairs chief Temi Folaranmi said in a statement. “Missed vaccinations during the pandemic makes children even more vulnerable to vaccine-preventable diseases like measles.”
GSK studied the safety of the vaccine in more than 12,000 people, roughly three-quarters of whom were children aged 12 to 15 months. There were also about 3,000 kids ages four to six years old, and another 454 children and adults older than seven.
These age groups follow the CDC’s recommendations that children receive their first MMR vaccine at 12 to 15 months and their second at four to six years, GSK said. Regulators are allowing the shot to be dosed as a two-shot series, or as the second dose if patients had previously received another MMR vaccine.
The new shot is just the second MMR vaccine approved in the US, and the first stateside since 1971, per the CDC. To this point, American pediatricians only had Merck’s M-M-R II shot available to administer to children.