GSK Receives FDA Approval for Priorix Measles, Mumps, and Rubella Vaccine

GSK plc announced on June 6, 2022, that the U.S. Food and Drug Administration (FDA) has approved Priorix (Measles, Mumps and Rubella Vaccine, Live). The vaccine is indicated for active immunization to prevent measles, mumps, and rubella in individuals 12 months of age and older.

Priorix is currently licensed in over 100 countries worldwide, including major markets in Europe, Canada, and Australia, with more than 800 million doses distributed to date. Its approval in the U.S. provides healthcare providers with an additional option to help protect patients against these highly contagious diseases, strengthening GSK's pediatric vaccine portfolio.

Measles, mumps, and rubella are acute and highly contagious viral diseases. Recent years have seen measles outbreaks in the U.S. and globally, reversing progress toward elimination. Reports indicate a decline in childhood vaccinations through programs like Vaccines For Children, increasing vulnerability to preventable diseases. This approval aims to address potential shortfalls in immunization coverage.

The vaccine's safety and efficacy were evaluated in six clinical studies involving over 12,000 participants, including more than 6,000 in the U.S. Common adverse reactions reported included pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever. The efficacy of Priorix was demonstrated based on immunogenicity data compared to a comparator vaccine.

Priorix will offer U.S. healthcare professionals another choice for MMR vaccination. It can be administered as a first dose and as a second dose to individuals who have previously received a first dose of another MMR-containing vaccine. The U.S. Centers for Disease Control and Prevention (CDC) recommends two doses of MMR vaccine for children, starting at 12 through 15 months of age, with the second dose at 4 through 6 years of age. Teens and adults should also remain up-to-date on their MMR vaccinations.