By IDSE News Staff

The FDA approved a live measles, mumps and rubella (MMR) vaccine (Priorix, GSK) for active immunization to prevent these diseases in patients 12 months of age and older.

The safety of the new MMR vaccine was evaluated in six clinical studies, in which a total of 12,151 participants (6,391 in the United States) received at least one dose of the MMR vaccine: 8,780 children (4,148 in the United States) 12 through 15 months of age; 2,917 children (1,950 in the United States) 4 through 6 years of age; and 454 adults and children (293 in the United States) 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 the MMR vaccine was demonstrated based on immunogenicity data versus the comparator vaccine.

Anaphylaxis and febrile seizures can follow vaccination. For more, see the prescribing information.

The new vaccine will provide U.S. healthcare professionals with another MMR vaccine choice. The MMR vaccine may be administered as a first dose followed by a second dose, or given as a second dose to people who have previously received the first dose of another MMR-containing vaccine.

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 also should be up to date on their MMR vaccination, according to the CDC.

The MMR vaccine is scheduled to be on the agenda for the June 17-18 Advisory Committee on Immunization Practices meeting for consideration of formal inclusion into the vaccine schedule and recommendations.
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 United States 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 CDC report, vaccine ordering in the past two years through the CDC’s Vaccines For Children program, the federal program through which about half of children in the country are immunized, dropped more than 10%, indicating that fewer vaccinations in children were occurring (MMWR Morb Mortal Wkly Rep 2022;71[16]:561-568). 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 immunizations such as their MMR vaccination.

“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization. Missed vaccinations during the pandemic makes children even more vulnerable to vaccine-preventable diseases like measles,” said Temi Folaranmi, MD, the vice president and vaccines therapeutic area head, US Medical Affairs, GSK. “Making Priorix available to patients in the U.S. will ensure healthcare professionals have more than one option for this critical vaccine as they work to catch their patients up on recommended vaccinations.”

GSK said that it will begin taking GSKDirect pre-orders for Priorix starting June 6. The vaccine is expected to be available for next day ordering starting early August on GSKDirect, and will also be available through GSK authorized wholesalers and distributors at that time.