GSK’s vaccine for the prevention of measles, mumps and rubella (MMR) has been approved by the US FDA, the company has announced.
The approval of GSK’s Priorix in the US gives patients another option for being vaccinated against MMR. The vaccine is already licensed in over 100 countries and more than 800 million doses have been distributed.
According to the US Centers for Disease Control and Prevention (CDC), vaccine ordering fell more than 10% in the last two years, resulting in fewer vaccinations in children occurring.1
MMR is a combination of acute and highly-contagious viral diseases that cause considerable health impacts across the world. In 2019, it was estimated that there were over 9 million cases of measles, a figure that dropped throughout Covid-19 due to measures such as social distancing and mask wearing.2
Priorix was evaluated in six clinical studies, totalling over 12,000 patients, 6,391 of those being in the US. Patients received at least one dose of Priorix with the majority of patients aged 12 through 15 months. 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 now be available as first dose as an MMR vaccine and also as a second dose to individuals who have previously received the first dose of another MMR-containing vaccine.
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.
“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 paediatric vaccine portfolio,” said Judy Stewart, Senior Vice President and Head of US Vaccines, GSK.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunisation. 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. “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.”