GSK files for licensure of MMR vaccine in the US

For media and investors only

Issued: 2 August 2021, Philadelphia

• GSK seeks US approval of PRIORIX vaccine licensed in more than 100 countries

• If approved, PRIORIX will bring a second source of MMR vaccine to US market

GSK today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for PRIORIX (Measles, Mumps, and Rubella Virus Vaccine, Live) and is seeking approval for use in active immunization against infection by measles, mumps and rubella (MMR).

The MMR vaccine developed by GlaxoSmithKline (GSK) was first registered in Germany in 1997 and is currently licensed in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 400 million doses distributed to date.

“If approved, PRIORIX will increase the number of vaccine offerings from GSK against childhood diseases in the US market and strengthen GSK’s long-term commitment to prioritizing public health in the US,” said Judy Stewart, Senior Vice President and Head of US Vaccines at GSK.

Measles, mumps and rubella are acute and highly contagious viral diseases that are responsible for considerable morbidity and mortality throughout the world.[1]^,[2] In recent years, measles outbreaks have occurred in the United States and globally with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries.[3]

“Outbreaks of measles in recent years demonstrate how quickly diseases can return in the absence of widespread immunization. This submission brings us one step closer to making PRIORIX available to the patients in the US and ensuring that health care professionals will have more than one option for this important disease prevention tool,” said Barbara Howe, MD, Vice President and Director, Vaccines Medical and Clinical, US at GSK.

The safety of PRIORIX was evaluated in six clinical studies, in which a total of 17,393 subjects received at least one dose of either PRIORIX or a US-licensed Measles, Mumps, and Rubella Virus Vaccine, Live (M-M-R^®_II) (Merck & Co., Inc.). The studies included 12,475 children aged 12 to 15 months, 4,007 children aged 4 to 6 years, and 911 adults and children aged 7 years or older. The efficacy of PRIORIX was demonstrated based on comparative immunogenicity data with M-M-R^®_II. The most commonly-reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever. 

If approved, PRIORIX would provide US healthcare providers with another MMR vaccine choice. GSK is also seeking approval for PRIORIX administration as a second dose to individuals who received another MMR vaccine.

The Centers for Disease Control and Prevention (CDC) recommends that people get MMR vaccine to protect against measles, mumps and rubella. Children should get two doses of MMR vaccine, starting with the first dose at 12 to 15 months of age, and the second dose at 4 through 6 years of age. Teens and adults should also be up to date on their MMR vaccination.[4]

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/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 2020 and any impacts of the COVID-19 pandemic.

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Note to editors:

The name PRIORIX is not yet approved for use by the US Food and Drug Administration (FDA).

[1] Centers for Disease Control and Prevention. About Global Measles, Rubella, and Congenital Rubella Syndrome (CRS). Avalaile at: https://www.cdc.gov/globalhealth/measles/about/index.html. Accessed July 2021.

[2] Su, S. B., Chang, H. L., & Chen, A. K. Current Status of Mumps Virus Infection: Epidemiology, Pathogenesis, and Vaccine. International Journal of Environmental Research and Public Health 2020, 17(5), 1686. https://doi.org/10.3390/ijerph17051686.

[3] World Health Organization. Immunization Analysis and Insights. Available at: https://www.who.int/teams/immunization-vaccines-and-biologicals/immunization-analysis-and-insights/surveillance/surveillance-for-vpds. Accessed July 2021.

[4] Centers for Disease Control and Prevention. Measles, Mumps, and Rubella (MMR) Vaccination: What Everyone Should Know. Available at: https://www.cdc.gov/vaccines/vpd/mmr/public/index.html. Accessed July 2021.