GSK announces US FDA approval of PRIORIX for the prevention of measles, mumps and rubella in individuals 12 months of age and older
- PRIORIX becomes an additional source of measles, mumps and rubella vaccine for US patients
PRIORIX is currently licenced in more than 100 countries worldwide, including all European countries,
“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
Measles, mumps and rubella are acute and highly-contagious viral diseases responsible for considerable morbidity and mortality throughout the world.1,2 In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries.3
According to a recent
“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
The safety of PRIORIX was evaluated in six clinical studies, in which a total of 12,151 participants (6,391 in the US) received at least one dose of PRIORIX: 8,780 children (4,148 in the US) 12 through 15 months of age; 2,917 children (1,950 in the US) 4 through 6 years of age; and 454 adults and children (293 in the US) 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 PRIORIX was demonstrated based on immunogenicity data versus the comparator vaccine.
PRIORIX will provide US healthcare professionals with another MMR vaccine choice. PRIORIXmay be administered as a first dose, followed by a second dose of PRIORIX. PRIORIXmay also be administered as a second dose to individuals
PRIORIX is scheduled to be on the agenda for the
The US Prescribing Information is available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Priorix/pdf/PRIORIX.PDF.
Important Safety Information
- The following is based on the US Prescribing Information for PRIORIX. Please consult the full Prescribing information for all the labelled safety information.
- Contraindications for PRIORIX are: severe allergic reaction (e.g., anaphylaxis) to any component of PRIORIX, or after a previous dose of any measles-, mumps- and rubella-containing vaccine; severe immunodeficiency; and pregnancy or planning to become pregnant within the next month.
- Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PRIORIX.
- There is a risk of febrile seizure following immunisation with PRIORIX.
- Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX.
- Syncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from fainting.
- The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.
- Vaccination with PRIORIX may not protect all susceptible individuals.
- Most common solicited adverse reactions in clinical trial participants: 12 through 15 months of age: local reactions were pain, and redness; systemic reactions were irritability, loss of appetite, drowsiness and fever; 4 through 6 years of age: local reactions were pain, redness and swelling; systemic reactions were loss of appetite, drowsiness and fever; and 7 years of age and older: local reactions were pain and redness.
GSK is a science-led global healthcare company. For further information please visit https://www.gsk.com/en-gb/about-us/.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK’s Q1 Results for 2022 and any impacts of the COVID-19 pandemic.
2 Su, S. B., Chang, H. L., & Chen, A. K. Current Status of Mumps Virus Infection: Epidemiology, Pathogenesis, and Vaccine.
4 Seither R, Laury J, Mugerwa-Kasujja A, Knighton CL, Black CL. Vaccination Coverage with Selected Vaccines and Exemption Rates Among Children in Kindergarten —