FDA Approves First New Measles, Mumps and Rubella Vaccine in 50 Years

GlaxoSmithKline (GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved its measles, mumps and rubella vaccine Priorix for the prevention of measles, mumps and rubella (MMR) in children over 12 months of age. This is the second MMR vaccine approved by the US FDA, with the first MMR vaccine approved in 1971.

Measles, mumps and rubella are highly contagious viral diseases that cause significant illness and death globally. In recent years, there have been multiple outbreaks of measles worldwide, with more than 400,000 confirmed cases in 2019, reversing decades of progress towards measles elimination.

Priorix is a live attenuated vaccine that has previously been approved in more than 100 countries and territories around the world. Its safety has been evaluated in six clinical trials totaling more than 12,000 participants. The most common adverse events were pain, redness, decreased appetite, irritability, somnolence and fever. The efficacy of Priorix was demonstrated by comparison with the immunogenicity of the control vaccine.

"Measles outbreaks in recent years have shown that without widespread vaccination, infectious diseases can return quickly," said Dr. Temi Folaranmi, Head of Vaccine Therapeutics, GSK US Medical Affairs. "The approval of Priorix gives healthcare workers a new vaccination option. "