FDA Approves Priorix Vaccine for Measles, Mumps, and Rubella

The FDA has approved Priorix (measles, mumps and rubella [MMR] vaccine, live; GSK) active immunization for the prevention of measles, mumps, and rubella (MMR) in individuals 12 months of age and older. Priorix can be administered as a first dose, followed by a second dose of the vaccine, or as a second dose to those previously administered the first dose of another MMR-containing vaccine.

The efficacy of Priorix was demonstrated based on immunogenicity data versus the comparator vaccine, according to GSK. The vaccine is set to be on the agenda this month for review by the CDC Advisory Committee on Immunization Practices for consideration of formal inclusion into the vaccine schedule and recommendations.

“We’re proud to make Priorix available in the United States 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,” said Judy Stewart, senior vice president and head of US Vaccines, GSK, in a press release.

MMR are acute and highly contagious viral diseases that cause significant morbidity and mortality worldwide. Recent measles outbreaks both in the United States and worldwide accounted for than 400,000 confirmed cases in 2019, which undid decades of progress toward measles elimination in many countries, according to GSK.

The safety of Priorix was evaluated in a series of 6 clinical studies, with 12,151 participants (6391 in the United States) administered at least 1 dose of Priorix. These included 8780 children (4148 in the United States) 12 through 15 months of age; 2917 children (1950 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 common adverse events with Priorix were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever.

A recent CDC report noted that vaccine ordering has declined by more than 10% over the past 2 years through the CDC’s Vaccines For Children program, through which approximately half of US children are immunized. This statistic indicates that fewer children are being administered vaccinations, according to the CDC.

The report also found that 400,000 fewer children entered kindergarten in the 2020-2021 school year than was expected nationally, which suggests they may not be up to date on childhood immunizations, according to the report.

The CDC recommends children receive 2 doses of an MMR vaccine, starting with the first dose at 12 through 15 months of age and a second dose at 4 through 6 years of age.

“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, vice president and Vaccines Therapeutic Area Head, US Medical Affairs, GSK, in a press release. “Making Priorix available to patients in the US will ensure health care professionals have more than one option for this critical vaccine as they work to catch their patients up on recommended vaccinations.”

Reference

GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older. GKS. News release. June 6, 2022. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-us-fda-approval-of-priorix-for-the-prevention-of-measles-mumps-and-rubella-in-individuals-12-months-of-age-and-older/