GSK’s Priorix MMR vaccine received the federal agency’s approval which was based from data of 6 clinical trials evaluating its safety.
The Food and Drug Administration (FDA) has approved GSK’s measles, mumps and rubella (MMR) vaccine, Priorix, for individuals 12 months of age and older.
“We’re proud to make Priorix available in the US for the first time, adding a choice for providers to help protect patients against these highly-contagious diseases and to further strengthen offerings in our pediatric vaccine portfolio,” Judy Stewart, senior vice president and head of US Vaccines, GSK, said.
The GSK vaccine was studied in 6 clinical trials, in which a total of 12,151 participants (6391 in the US) received at least 1 dose of Priorix: 8780 children (4148 in the US) 12 through 15 months of age; 2917 children (1950 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.
The Centers for Disease Control and Prevention (CDC) recommends children get 2 doses of the MMR vaccine beginning with the first dose at 12 through 15 months of age, and the second dose at 4 through 6 years of age.
Priorix currently licensed in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand.
The GSK MMR vaccine is scheduled to be on CDC Advisory Committee on Immunization Practices (ACIP) meeting agenda this month for consideration of formal inclusion into the vaccine schedule and recommendations.