GSK begins shipping FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT

GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its quadrivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2022-23 season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research.

GSK expects to distribute over 50 million doses of its influenza vaccine to the US market, continuing to support annual immunization across the US. Despite increased large-scale public health efforts in the 2021-2022 flu season, vaccination rates were similar to the 2020-2021 season. The US Centers for Disease Control and Prevention (CDC) data from April 2022 also showed significant disparities in vaccination coverage for many age groups and ethnicities.¹

“The COVID-19 pandemic has shone a light on health disparities in the US and that there is still much more to be done to close the gap. GSK is committed to working alongside our public health partners to increase education and awareness about annual flu vaccination across the board, but especially in underserved communities of color,” said Temi Folaranmi, Vice President and Vaccines Therapeutic Area Head, US Medical Affairs, GSK.

Both FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT will be available in a 0.5mL, single-dose, pre-filled syringe, and are indicated for patients six months and older in line with CDC recommendations.

CDC recommends an annual flu vaccination for anyone aged six months and older who do not have contraindications. According to CDC, annual influenza vaccinations are the best way to help protect against the flu.²

For egg-based influenza vaccines for the 2022-23 flu season, the World Health Organization and FDA’s Vaccines and Related Biological Products Advisory Committee recommended including an A/Victoria/2570/2019 (H1N1) pdm09-like virus, an A/Darwin/9/2021 (H3N2)-like virus, a B/Austria/1359417/2021 (B/Victoria lineage)-like virus and a B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.³

About Influenza

The flu (influenza) is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs. It can cause mild to severe illness, and at times can lead to death. The best way to prevent flu is by getting a flu vaccine each year.²

Anyone can get the flu, however, it can be serious for young children, adults 65 years and older, pregnant women and people with pre-existing chronic health conditions, such as asthma.²

For more information about the flu, visit https://us.gsk.com/en-us/about-us/vaccines/flu.

Indication for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccines. FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are approved for use in persons aged 6 months and older.

Important Safety Information for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

• Do not administer FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine

• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT should be based on careful consideration of the potential benefits and risks

• Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

• If FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons

• In clinical trials with FLUARIX QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common systemic adverse reactions were muscle aches, headache, and fatigue. In children 6 through 35 months of age, the most common solicited local adverse reactions were pain and redness and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children 3 through 17 years of age, the solicited local adverse reactions were pain, redness, and swelling. In children 3 through 5 years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 through 17 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLUARIX QUADRIVALENT for other potential adverse reactions and events)

• In clinical trials with FLULAVAL QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were muscle aches, headache, fatigue, and arthralgia. In children 6 through 35 months of age, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 3 through 17 years of age, the most common solicited local adverse reaction was pain. In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLULAVAL QUADRIVALENT for other potential adverse reactions and events)

• Vaccination with FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT may not result in protection in all vaccine recipients

Please see full Prescribing Information for FLUARIX QUADRIVALENT and for FLULAVAL QUADRIVALENT.

About GSK

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.

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References

1. Centers for Disease Control and Prevention. Weekly Flu Vaccination Dashboard. Available at: https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html. Accessed July 2022.
2. Centers for Disease Control and Prevention. About Flu. Available at: https://www.cdc.gov/flu/about/index.html. Accessed July 2022.
3. World Health Organization. Recommendations announced for influenza vaccine composition for the 2022-2023 northern hemisphere influenza season. https://www.who.int/news/item/25-02-2022-recommendations-announced-for-influenza-vaccine-composition-for-the-2022-2023-northern-hemisphere-influenza-season. Accessed July 2022.

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