GSK announces US FDA approval of Priorix for preventing Measles, Mumps and Rubella

GSK yesterday announced that the US Food and Drug Administration (FDA) has approved Priorix for active immunisation for the prevention of Measles, Mumps and Rubella (MMR) in individuals 12 months of age and older, the company said in a statement.

Priorix is currently licensed in over 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 800 million doses distributed to date, the statement added.

It also mentioned that 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) four through six years of age; and 454 adults and children (293 in the US) seven 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 the 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, according to the statement.

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, the statement concluded.