FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older.- GSK

Priorix is currently licenced in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 800 million doses distributed to date

Measles, mumps and rubella are acute and highly-contagious viral diseases responsible for considerable morbidity and mortality throughout the world. In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries.

According to a recent US Centers for Disease Control and Prevention (CDC) report, vaccine ordering in the past two years through the CDC’s Vaccines For Children programme, the federal programme through which about half of the children in the country are immunised, dropped more than 10%, indicating that fewer vaccinations in children were occurring. The report also noted 400,000 fewer children entered kindergarten in the 2020-2021 school year than expected nationally, meaning those children may not be up to date on childhood immunisations like their MMR vaccination.

The safety of Priorix was evaluated in six clinical studies, in which a total of 12,151 participants (6,391 in the US) received at least one dose of Priorix: 8,780 children (4,148 in the US) 12 through 15 months of age; 2,917 children (1,950 in the US) 4 through 6 years of age; and 454 adults and children (293 in the US) 7 years of age and older. The most commonly reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness and fever. The efficacy of Priorix was demonstrated based on immunogenicity data versus the comparator vaccine.

Priorix will provide US healthcare professionals with another MMR vaccine choice. Priorix may be administered as a first dose, followed by a second dose of Priorix. Priorix may also be administered as a second dose to individuals who have previously received the first dose of another MMR-containing vaccine.

The CDC recommends people get a MMR vaccine to protect against measles, mumps and rubella. Children should get two doses of MMR vaccine, starting with the first dose at 12 through 15 months of age, and the second dose at 4 through 6 years of age. Teens and adults should also be up to date on their MMR vaccination.

.Priorix is scheduled to be on the agenda for the June CDC Advisory Committee on Immunization Practices (ACIP) meeting for consideration of formal inclusion into the vaccine schedule and recommendations.