The U.S. FDA has approved Priorix, GlaxoSmithKline’s vaccine for measles, mumps and rubella (MMR) for use in patients aged 12 months and older.
While measles had once been considered eradicated from the United States thanks to vaccination efforts, the CDC has reported a resurgence in cases in the last few years. In 2019, 1,282 cases were reported, a staggering increase from 275 the year before.
While Priorix had been licensed in more than 100 countries worldwide, it is now available for the first time in the U.S. — adding another immunization option that providers can offer to parents. The new vaccine will compete with Merck's M-M-R II vaccine, which won FDA approval back in 2008.
“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.
The approval was supported by data from six clinical studies that included a total of 12,151 participants, 8,780 of whom were children. The studies confirmed that the vaccine elicited immunity and caused no serious adverse effects.
GSK also stated that Priorix is scheduled to be on the agenda for the June CDC Advisory Committee on Immunization Practices (ACIP) meeting to be considered for formal inclusion into vaccine schedule and recommendations.