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GSK File for MMR Vaccine Approval in the US | Around the Web-Pennsylvania

Philadelphia, August 2, 2021 / PRNewswire / -GSK today submitted a PRIORIX (Measles, Mumps, and Rubella Virus Vaccine, Live) biopharmacy approval application (BLA) to the US Food and Drug Administration (FDA) for approval for use in active immunization. Announced that they are seeking. Immunity against measles, mumps, and rubella (MMR) infections.

The MMR vaccine developed by GlaxoSmithKline (GSK) Germany In 1997, it is now licensed in more than 100 countries around the world, including all European countries. Canada, Australia When new ZealandSo far, more than 400 million doses have been distributed.

“If approved, PRIORIX will increase the number of vaccines provided by GSK for childhood diseases in the US market and strengthen GSK’s long-term commitment to prioritizing US public health,” he said. Judy Stewart, Senior Vice President and Head of Vaccines, GSK.

Measles, mumps and rubella are acute and highly contagious viral diseases that cause significant morbidity and mortality worldwide.1,2 In recent years, the outbreak of measles has United States of America And worldwide, more than 400,000 cases were confirmed in 2019, reversing decades of progress towards eradicating measles in many countries.3

“Recent measles outbreaks show how quickly the disease recurs in the absence of extensive immunization. This submission makes PRIORIX available to patients in the United States and has multiple medical professionals. This will ensure that you have access to your options. This is an important disease prevention tool. ” Barbara Howe, MD, GSK, US Vaccine Medicine and Clinical Vice President and Director..

The safety of PRIORIX was evaluated in 6 clinical trials. In this study, a total of 17,393 subjects received at least one dose of either PRIORIX or a US-approved measles, mumps, or rubella virus vaccine.®II) (Merck & Co., Inc.). The study 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 and older. The effectiveness of PRIORIX was demonstrated based on comparative data on immunogenicity with MMR.®II.. The most commonly reported side effects were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever.

If approved, PRIORIX will offer US healthcare providers another MMR vaccine option. GSK is also seeking approval for PRIORIX as a second dose to individuals who have been vaccinated with another MMR vaccine.

The Centers for Disease Control and Prevention (CDC) recommends vaccination with the MMR vaccine to protect against measles, mumps and rubella. The child should be vaccinated twice with the MMR vaccine. The first vaccination is 12 to 15 months old and the second vaccination is 4 to 6 years old. Teens and adults also need to be up-to-date on MMR vaccination.Four

About GSK

GSK is a science-led global health care company with the special purpose of helping people do more, feel better and live longer. For more information, please visit: www.gsk.com/about-us..

US Media Inquiries:

Evan Burland

Sean Clements

+1 215 432 0234

+1 215 740 3088

(Philadelphia)

(Philadelphia)

Inquiries from analysts / investors:

James Dodwell

+44 (0) 20 8047 2406

(London)

Sonya Gobrial

+44 (0) 7392 784784

(consumer)

Mick Lady

+44 (0) 7990 339653

(London)

Jeff McLaughlin

+1 215 751 7002

(Philadelphia)

Franny Defranco

+1 215 751 4855

(Philadelphia)

Precautions regarding future prospects

GSK warns investors that forward-looking statements or forecasts by GSK, including this announcement, may be subject to risks and uncertainties that may cause actual results to differ materially from the forecasts. To do. Such factors include, but are not limited to, those described in our annual report on Form 20-F for 2020 and the impact of the COVID-19 pandemic.

Register with England & Wales:

Number 3888892

Registration office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

Note to editors:

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

1 Centers for Disease Control and Prevention. About measles, rubella, congenital rubella syndrome (CRS). Available locations: https://www.cdc.gov/globalhealth/measles/about/index.html.. Accessed in July 2021.

2 Current Status of Su, SB, Chang, HL, and Chen, AK Mumps Virus Infections: Epidemiology, Causes, and Vaccines. International Journal of Environmental Studies and Public Health 2020, 17 (5), 1686. https://doi.org/10.3390/ijerph17051686..

3 World Health Organization. Immunization analysis and insights. available: https://www.who.int/teams/immunization-vaccines-and-biologicals/immunization-analysis-and-insights/surveillance/surveillance-for-vpds.. Accessed in July 2021.

Four Centers for Disease Control and Prevention. Measles, Mumps, Rubella (MMR) Vaccinations: What Everyone Should Know. available: https://www.cdc.gov/vaccines/vpd/mmr/public/index.html.. Accessed in July 2021.

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Source GSK

GSK File for MMR Vaccine Approval in the US | Around the Web-Pennsylvania

Source link GSK File for MMR Vaccine Approval in the US | Around the Web-Pennsylvania

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