FDA Approves Additional MMR Vaccine

The US Food and Drug Administration (FDA) has approved the live measles, mumps, and rubella (MMR) vaccine, Priorix, for preventive use in individuals aged 12 months or older.

The vaccine is delivered in a 2-dose series or as the second dose in individuals who previously received the first dose of another MMR-containing vaccine. The Centers for Disease Control and Prevention (CDC) recommend individuals receive the first dose at 12 to 15 months of age and the second dose at 4 to 6 years of age. All adolescents and adults are also recommended to be up to date on their MMR immunizations.

The approval was based on the results of 6 clinical studies. Included were a total of 12,151 participants who received at least 1 dose of the vaccine, of whom 6301 participants were based in the United States. Of the total participants, 8780 children were 12 to 15 months of age, 2917 were 4 to 6 years of age, and 454 were 7 years of age or older.

Pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever were among the most common adverse effects.

“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization,” concluded Temi Folaranmi, MD, Vice President and Vaccines Therapeutic Area Head of the vaccine’s manufacturer, GSK.

—Leigh Precopio

Reference:

GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older. News release. GSK; June 6, 2022. Accessed June 7, 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-us-fda-approval-of-priorix-for-the-prevention-of-measles-mumps-and-rubella-in-individuals-12-months-of-age-and-older/