GSK is first to ship influenza vaccine doses for the 2023-24 flu season in US
July 13 2023 - 8:23AM
Business Wire
- GSK supports annual flu immunization with its shipping of
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 2023-24 flu season.
This immediately follows a licensing and lot-release approval from
the US Food and Drug Administration (FDA).
GSK expects to distribute over 40 million doses of its influenza
vaccine to the US market. 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.
CDC recommends an annual flu vaccination for anyone aged six
months and older who does not have contraindications.
According to CDC, annual influenza vaccination is the best way
to help protect against the flu, with September and October being
the best time for most people to be vaccinated.1 CDC estimates
that, from October 1, 2022 through April 30, 2023, there have been
27 – 54 million flu illnesses, 300,000 – 650,000 flu
hospitalizations and 19,000 – 58,000 flu deaths.2
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.3
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.4
For more information about the flu, visit
https://www.cdc.gov/flu/about/keyfacts.htm.
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 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 global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together.
Find out more at gsk.com.
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
2022, and Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
References
- Centers for Disease Control and Prevention. 2023-2024 CDC Flu
Vaccination Recommendations Adopted. Available at:
https://www.cdc.gov/flu/spotlights/2022-2023/flu-vaccination-recommendations-adopted.htm.
Accessed July 11, 2023.
- Centers for Disease Control and Prevention. 2022-2023 U.S. Flu
Season: Preliminary In-Season Burden Estimates. Available at:
https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm.
Accessed July 11, 2023.
- Centers for Disease Control and Prevention. About Flu.
Available at: https://www.cdc.gov/flu/about/index.html. Accessed
July 11, 2023.
- Centers for Disease Control and Prevention. Key Facts About
Influenza (Flu). Available at:
https://www.cdc.gov/flu/about/keyfacts.htm. Accessed July 11,
2023.
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