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FDA Approves GSK’s MMR Vaccine
On Monday morning, pharmaceutical giant GlaxoSmithKline (GSK) announced the approval of its widely licensed measles, mumps, and rubella (MMR) vaccine by the FDA. Branded as Prioix, the shot has been approved for active immunisation in children 12 months and older. Already licensed in over 100 countries, including across all of Europe, North America, and Oceania, more than 800 million Prioix doses have been administered to date.
The Prioix is only the second MMR vaccine to be approved in the US. Until this point, the first and only available vaccine was Merck’s M-M-R II shot, which was passed by the Centers for Disease Control and Prevention (CDC) in 1971. Measles, mumps, and rubella are highly contagious viral diseases with a considerable morbidity and mortality rate. In 2019 alone, 400,000 cases of measles were confirmed worldwide.
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“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 at GSK in an official press release.
“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 at GSK.
“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunisation.”
GSK tested the safety of the Priorix vaccine in more than 12,000 patients across six clinical trials. The studies evaluated approximately 8,700 children aged 12 to 15 months, 3,000 children ages four to six years old, and 454 children and adults aged seven years and over. The efficacy of GSK’s Priorix vaccine was measured and determined by immunogenicity data versus the comparator vaccine.
The official roll-out of Priorix will follow the CDC’s recommendations that the first dose be administered in children between the ages of 12 to 15 months. Regulators approve a second dosage at four to six years. While a two-shot series approach will be adopted, a second dosage using Priorix will also be made available for those who received a different first MMR vaccine.
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