GSK begins shipping record number of its influenza vaccine doses for 2020-21 season for US market

GSK today announced it started shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2020-21 flu 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.

“The flu is a serious and unpredictable disease that causes tens of millions of illnesses, hundreds of thousands of hospitalizations and tens of thousands of deaths in the US each year,”[i] said Judy Stewart, Senior Vice President, US Vaccines. “GSK is looking at every opportunity to produce and distribute additional flu vaccines this upcoming season to meet anticipated demand. We are working closely with public health partners to improve flu immunization rates to reduce the spread of disease and burden on the healthcare system during the ongoing public health challenge presented by the COVID-19 pandemic.”

The US Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months of age and older get a flu vaccine every season. In recent weeks, the CDC has repeatedly emphasized the importance of influenza vaccination this flu season to help reduce the burden of disease and the impact of influenza on the healthcare system and other critical infrastructures during the COVID-19 pandemic.

GSK expects to supply more than 50 million doses of its influenza vaccines for the US market in the 2020-21 season, an increase from the 46 million it distributed during the 2019-20 influenza season. With shipments this season, GSK will cross the 1 billion doses manufactured globally milestone during the company’s history.

“Many people have fallen behind on their routine immunizations during the COVID-19 stay-at-home orders with immunization rates declining for children, adolescents and adults,”[ii] said Dr. Leonard Friedland, VP, Director of Scientific Affairs and Public Health, Vaccines, GSK. “The CDC has urged individuals to maintain or reinitiate routine immunization across the lifespan to prevent illnesses that could lead to unnecessary medical visits, hospitalization and further strain on the healthcare system. As we head into flu season, it’s important to not only get a flu vaccine, but to prioritize getting caught up on all CDC-recommended vaccines, particularly for adults and vulnerable populations.”

Both FLULAVAL QUADRIVALENT and FLUARIX QUADRIVALENT will be available in a 0.5mL, single-dose, pre-filled syringe, and indicated for patients 6 months and older in line with CDC recommendations.

According to the CDC, annual influenza vaccination is the best available tool to help protect people 6 months and older against the flu. The CDC has estimated that flu vaccination during the 2018-19 flu season prevented approximately 4.4 million illnesses, 2.3 million medical visits and 58,000 hospitalizations associated with the flu.[iii]

For the 2020-21 flu season, the World Health Organization and FDA’s Vaccines and Related Biological Products Advisory Committee recommended including the A/Guangdong-Maonan/SWL1536/2019 (H1N1) pdm09-like virus, A/HongKong/2671/2019 (H3N2)-like virus, B/Washington/02/2019- like virus (B/Victoria lineage), with the addition of B/Phuket/3073/2013-like (B/Yamagata lineage) virus for the quadrivalent vaccine.[iv]

About seasonal influenza

Seasonal influenza (the “flu”) is a contagious respiratory illness, caused by flu viruses.[v] There are two main types of flu viruses, A and B, that are spread person-to-person and can cause mild to severe illness.[vi] Most flu cases in the US occur from October through May, with cases usually peaking between December and February.[vii]

While anyone can get the flu, it can be particularly serious for young children, adults 65 years and older, pregnant women and people with pre-existing chronic health conditions, such as asthma.[viii] According to the CDC, the best tool available to help protect yourself and those around you against the flu is to get vaccinated. The more people who are vaccinated, the less chance the virus has to spread.[ix] The CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.[x]

For more information about the flu, visit 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 age 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 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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

[i] Centers for Disease Control and Prevention. Disease Burden of Influenza. Available at: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm.

[ii] Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the COVID-19 Pandemic on Routine Pediatric Vaccine Ordering and Administration — United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:591–593. DOI: http://dx.doi.org/10.15585/mmwr.mm6919e2.

[iii] Centers for Disease Control and Prevention. 2018-19 Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths Averted by Vaccination. Available at: www.cdc.gov/flu/about/burden-averted/2018-2019.htm.

[iv] Food and Drug Administration. Influenza Virus Strains Chosen for Inclusion in the U.S. 2020-2021 Influenza Season Vaccine. Available at: https://www.fda.gov/media/136302/download.

[v] Centers for Disease Control and Prevention. Key Facts about Influenza (Flu). Available at: www.cdc.gov/flu/keyfacts.htm.

[vi] Centers for Disease Control and Prevention. Types of Influenza Viruses. Available at: https://www.cdc.gov/flu/about/viruses/types.htm.

[vii] Centers for Disease Control and Prevention. The Flu Season. Available at: www.cdc.gov/flu/about/season/flu-season.htm.

[viii] Centers for Disease Control and Prevention. People at High Risk of Developing Flu–Related Complications. Available at: www.cdc.gov/flu/about/disease/high_risk.htm.

[ix] Centers for Disease Control and Prevention. What Would Happen If We Stopped Vaccinations? Available at: www.cdc.gov/vaccines/vac-gen/whatifstop.htm.

[x] Centers for Disease Control and Prevention. Who Should and Who Should NOT get a Flu Vaccine. Available at: https://www.cdc.gov/flu/prevent/whoshouldvax.htm