PHILADELPHIA, July 23, 2021 /PRNewswire/ -- GSK today announced it started shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2021-22 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.
GSK expects to distribute more doses than it has in any previous influenza season, with a record supply of more than 50 million doses of its influenza vaccine for the 2021-2022 season to the US market.
The US Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months of age and older who do not have contraindications 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.
"Many people have fallen behind on their routine immunizations during the pandemic, causing immunization rates to decline across the lifespan; from children to adults, including influenza vaccination during the 2020-2021 season,"1,2,3 said Dr. Leonard Friedland, VP, Director of Scientific Affairs and Public Health, GSK Vaccines.
"The flu remains a serious and unpredictable disease that can result in mild to severe illness. As more people are vaccinated against COVID-19 and we return to more normal, social activities, it is important that anyone over the age of 6 months is vaccinated against the flu."
A recent claims analysis commissioned by GSK and conducted by Avalere Health showed a significant and sustained drop in immunization rates for recommended vaccines among adolescents and adults throughout the pandemic in 2020,3 including influenza immunization. The report indicated rates were lower in 2020 than in 2019, with total influenza vaccinations dropping 14-35% in 2020 compared to 2019.1
"The Avalere Health study showed us that the need for people to make up for missed healthcare visits and receive their recommended immunizations is stronger than ever," said Judy Stewart, Senior Vice President and Head of US Vaccines at GSK. "GSK's focus continues to be increasing vaccination rates during the COVID-19 pandemic and flu vaccination is an integral part of that public health effort."
The CDC's updated recommendation on COVID-19 vaccines and coadministration with other vaccines now notes that they can be administered without regard to timing. This includes simultaneous administration of COVID-19 vaccine and other vaccines on the same day, as well as coadministration within 14 days.4
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 way to help protect people 6 months and older against the flu. The CDC has estimated that flu vaccination during the 2019-20 flu season prevented approximately 7.5 million illnesses, 105,000 associated hospitalizations, and 6,300 deaths.5
For the 2021-22 flu season, the World Health Organization and FDA's Vaccines and Related Biological Products Advisory Committee recommended including A/Victoria/2570/2019 (H1N1) pdm09-like virus, A/Cambodia/e0826360/2020 (H3N2)-like virus, B/Washington/02/2019 (B/Victoria lineage)-like virus and B/Phuket/3073/2013 (B/Yamagata lineage)-like virus for egg-based vaccines.6
About seasonal influenza Seasonal influenza (the "flu") is a contagious respiratory illness, caused by flu viruses.7 There are two main types of flu viruses, A and B, that are spread person-to-person and can cause mild to severe illness.8 Most flu cases in the US occur from October through May, with cases usually peaking between December and February.9
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.10 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.11 The CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.12
Indication for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT
FLUARIX QUADRIVALENT and FLUAVAL 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 FLULAVALQUADRIVALENT
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
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.
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1 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.