PHILADELPHIA, July 20, 2016 /PRNewswire/ -- GSK [LSE/NYSE:
GSK] announced today it has begun shipping quadrivalent vaccine
doses to US healthcare providers, following licensing and
lot-release approval from the US Food and Drug Administration's
(FDA) Center for Biologics Evaluation and Research. It is the first
company to ship quadrivalent vaccine for the 2016-17 flu
season.
The US Centers for Disease Control and Prevention (CDC)
recommends flu vaccination as the single best measure for flu
prevention. The CDC has a routine recommendation for Americans over
the age of six months to get a flu vaccination each year as the
first and most important step in protecting against this
disease.1,2 GSK's flu vaccines are indicated for use in
persons three years and older.
"Our goal is to be a reliable partner in the annual flu
immunization campaign by developing and manufacturing high quality
quadrivalent influenza vaccines for the US population," said
Patrick Desbiens, Senior Vice
President, US Vaccines. "This year we introduced new functionality
to our eCommerce platform, www.GSKDirect.com, to allow
those who stock and administer our vaccines to further
accelerate delivery of their flu vaccines when they order directly
from us. We believe this enhancement supports healthcare providers
by helping to ensure that their patients have access to the
vaccines they need."
Two different options of the four-strain vaccines will be
available to customers. FLULAVAL® QUADRIVALENT comes in
a 5-mL, multidose vial containing 10 doses (0.5mL each), while
FLUARIX® QUADRIVALENT comes in a 0.5-mL, single-dose,
prefilled syringe.
GSK expects to supply up to 40 million doses across both
vaccines for the US market in the 2016-17 season. One hundred
percent of GSK supply is quadrivalent doses.
Quadrivalent vaccines are designed to help protect against two
different types of "A" flu strains and two types of "B" flu
strains. Influenza A and Influenza B are the viruses that spread
between people and can cause mild to severe illness, leading to
seasonal flu. Most flu activity in the US occurs from October-May,
and typically peaks in the US between December-February. According
to the CDC, each year approximately 5 to 20 percent of people in
the US get the flu and more than 200,000 people are hospitalized
for flu-related complications.3,4,5
For this year's flu season, the World Health Organization (WHO)
and FDA's Vaccines and Related Blood Products Advisory Committee
recommended including the A/California/7/2009 (H1N1)pdm09-like virus,
A/Hong Kong/4801/2014 (H3N2)-like
virus, and B/Brisbane/60/2008-like
virus (B/Victoria lineage), with
the addition of B/Phuket/3073/2013-like virus (B/Yamagata
lineage), for the quadrivalent vaccine.6,7
For more general information about the flu, visit
ChooseMoreChooseFour.com.
About GSK flu vaccine
manufacturing
FLUARIX® QUADRIVALENT is
manufactured in Dresden,
Germany. FLULAVAL®
QUADRIVALENT is manufactured in Ste-Foy,
Quebec, Canada.
The following Important Safety Information is based on the
Highlights section of the Prescribing Information for
FLULAVAL® QUADRIVALENT (Influenza Vaccine) and
FLUARIX® QUADRIVALENT (Influenza Vaccine). Please
consult the full Prescribing Information for all the labeled safety
information for FLULAVAL® QUADRIVALENT and
FLUARIX® QUADRIVALENT.
Professional Indication(s) for FLULAVAL®
QUADRIVALENT (Influenza Vaccine) and FLUARIX®
QUADRIVALENT (InfluenzaVaccine)
Indication for FLULAVAL®
QUADRIVALENT
FLULAVAL® QUADRIVALENT is a vaccine
indicated for active immunization for the prevention of disease
caused by influenza A subtype viruses and type B viruses contained
in the vaccine. FLULAVAL® QUADRIVALENT is approved for
use in persons 3 years of age and older.
Indication for FLUARIX®
QUADRIVALENT
FLUARIX® QUADRIVALENT is a vaccine
indicated for active immunization for the prevention of disease
caused by influenza A subtype viruses and type B viruses contained
in the vaccine. FLUARIX® QUADRIVALENT is approved for
use in persons 3 years of age and older.
Combined Important Safety Information for
FluLaval® Quadrivalent (Influenza Vaccine) and
Fluarix® Quadrivalent (InfluenzaVaccine)
- Do not administer FLULAVAL® QUADRIVALENT or FLUARIX®
QUADRIVALENT to anyone with known severe allergic reactions
(anaphylaxis) to any component of the vaccine, including egg
protein, or a life‐threatening reaction to previous administration
of any influenza vaccine
- If Guillain-Barré syndrome has occurred within 6 weeks of
receipt of a prior influenza vaccine, the decision to give
FLULAVAL® QUADRIVALENT or FLUARIX®
QUADRIVALENT should be based on careful consideration of the
potential benefits and risks
- Syncope (fainting) can occur in association with administration
of injectable vaccines. Procedures should be in place to avoid
falling injury and to restore cerebral perfusion following
syncope
- If FLULAVAL® QUADRIVALENT or FLUARIX®
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 FLULAVAL® QUADRIVALENT, the
most common solicited local adverse reaction in adults was pain.
The most common solicited systemic adverse reactions in adults were
muscle aches, headache, fatigue, and arthralgia. 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)
- In clinical trials with FLUARIX® QUADRIVALENT, the
most common injection site adverse reaction in adults was pain. The
most common systemic adverse reactions in adults were muscle aches,
headache, and fatigue. In children 3 through 17 years of age,
injection site 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)
- Vaccination with FLULAVAL® QUADRIVALENT or
FLUARIX® QUADRIVALENT may not result in protection in
all vaccine recipients
GSK – one of the world's leading research-based
pharmaceutical and healthcare companies – is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For further information please visit
www.gsk.com.
GSK
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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 2014.
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1
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The US Centers for
Disease Control and Prevention (CDC): "Preventing the Flu: Good
Health Habits Can Help Stop Germs," Available at:
http://www.cdc.gov/flu/protect/habits.htm. Accessed June
2016.
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2
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The US Centers for
Disease Control and Prevention (CDC): "Vaccination: Who Should Do
It, Who Should Not and Who Should Take Precautions," Available at:
http://www.cdc.gov/flu/protect/whoshouldvax.htm#annual-vaccination.
Accessed June 2016.
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3
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The US Centers for
Disease Control and Prevention (CDC): "Key Facts About Seasonal Flu
Vaccine," Available at:
http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed June
2016.
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4
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The US Centers for
Disease Control and Prevention (CDC): "What You Should Know for the
2015-2016 Influenza Season," Available at:
http://www.cdc.gov/flu/about/season/flu-season-2015-2016.htm.
Accessed June 2016.
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5
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The US Centers for
Disease Control and Prevention (CDC): "Information for Schools."
Available at: http://www.cdc.gov/flu/school/qa.htm. Accessed June
2016.
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6
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World Health
Organization (WHO): "Recommended Composition of Influenza Virus
Vaccines for use in the 2016-2017 Northern Hemisphere Influenza
Season," Available at:
http://www.who.int/influenza/vaccines/virus/recommendations/201602_recommendation.pdf?ua=1.
Accessed June 2016.
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7
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U.S. Food and Drug
Administration (FDA): "Influenza Virus Vaccines 2016-2017 Strain
Selection," Available at:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM497026.pdf.
Accessed June 2016.
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To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/gsk-ships-2016-17-seasonal-influenza-vaccines-for-us-market-300301672.html
SOURCE GSK