GSK PLC said its Priorix vaccine has been approved by the US Food and Drug Administration (FDA) for active immunisation for the prevention of measles, mumps and rubella (MMR) in people 12 months and older.
The approval means US patients now have an additional source of MMR vaccine, said the pharma group, previously known as GlaxoSmithKline, in a statement.
"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.
Measles, mumps and rubella are highly contagious viral diseases responsible for a large number of deaths worldwide. Measles outbreaks have occurred in the US and globally in recent years, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries.
According to the US Centers for Disease Control and Prevention (CDC), vaccine ordering in the past two years through the CDC's Vaccines For Children programme, dropped more than 10%, indicating that fewer vaccinations in children were occurring during the Covid-19 pandemic.
"Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunisation. Missed vaccinations during the pandemic make 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."
The safety of Priorix was evaluated in six clinical studies, with the most commonly reported adverse reactions being 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 may be administered as a first dose, followed by a second dose, or as a second dose to individuals who have previously received the first dose of another MMR-containing vaccine.
The vaccine is currently licensed in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 800 million doses distributed to date.