GSK prepares US for 2022-23 flu season with over 50 million influenza vaccine doses
July 11 2022 - 3:21PM
Business Wire
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.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford,
Middlesex TW8 9GS
References
- 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.
- Centers for Disease Control and Prevention. About Flu.
Available at: https://www.cdc.gov/flu/about/index.html. Accessed
July 2022.
- 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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