Wednesday, July 20, 2016

GSK ships 2016-17 seasonal influenza vaccines for US market – PR Newswire (press release)

The US Centers for Ailment Manage and Prevention (CDC) recommends flu vaccination as the single finest measure for flu prevention. The CDC has actually a book recommendation for Americans over the age of 6 months to grab a flu vaccination each year as the very first and crucial step in protecting versus this disease.1,2 GSK’s flu vaccines are indicated for usage in persons three years and older.

“Our objective is to be a reliable partner in the annual flu immunization campaign by making and manufacturing higher quality quadrivalent influenza vaccines for the US population,” said Patrick Desbiens, Senior Vice President, US Vaccines. “This year we introduced brand-new functionality to our eCommerce platform, www.GSKDirect.com, to enable those that stock and administer our vaccines to further accelerate delivery of their flu vaccines as soon as they order directly from us. We believe this enhancement supports healthcare providers by aiding to guarantee that their patients have actually access to the vaccines they need.”

Two various selections of the four-strain vaccines will certainly 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 the two vaccines for the US market in the 2016-17 season. One hundred percent of GSK supply is quadrivalent doses.

Quadrivalent vaccines are created to tips protect versus two various 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 easily trigger mild to significant illness, leading to seasonal flu. Most flu activity in the US occurs from October-May, and frequently peaks in the US between December-February. According to the CDC, each year around five to twenty percent of people in the US grab the flu and a lot more compared to 200,000 people are hospitalized for flu-related complications.3,4,5

For this year’s flu season, the Globe good health Organization (WHO) and FDA’s Vaccines and Related Blood Products Advisory Committee recommended including the A/California/7/2009 (H1N1)pdm09-adore virus, A/Hong Kong/4801/2014 (H3N2)-adore virus, and B/Brisbane/60/2008-adore virus (B/Victoria lineage), along with the addition of B/Phuket/3073/2013-adore virus (B/Yamagata lineage), for the quadrivalent vaccine.6,7

For a lot more general post regarding 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 adhering to vital Safety post is based on the Highlights section of the Prescribing post for FLULAVAL® QUADRIVALENT (Influenza Vaccine) and FLUARIX® QUADRIVALENT (Influenza Vaccine). Please consult the full Prescribing post for all of the labeled safety post 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 energetic immunization for the prevention of Ailment caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLULAVAL® QUADRIVALENT is approved for usage in persons 3 years of age and older.  

Indication for FLUARIX® QUADRIVALENT
FLUARIX® QUADRIVALENT is a vaccine indicated for energetic immunization for the prevention of Ailment caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUARIX® QUADRIVALENT is approved for usage in persons 3 years of age and older.

Combined vital Safety post for FluLaval® Quadrivalent (Influenza Vaccine) and Fluarix® Quadrivalent (InfluenzaVaccine)

  • Do not administer FLULAVAL® QUADRIVALENT or FLUARIX® QUADRIVALENT to anyone along with known significant allergic reactions (anaphylaxis) to any type of component of the vaccine, including egg protein, or a life‐threatening reaction to previous administration of any type of influenza vaccine
  • If Guillain-Barré syndrome has actually occurred within six weeks of receipt of a prior influenza vaccine, the decision to offer FLULAVAL® QUADRIVALENT or FLUARIX® QUADRIVALENT need to be based on careful consideration of the potential incentives and risks
  • Syncope (fainting) can easily occur in association along with administration of injectable vaccines. Procedures need to be in place to stay away from falling injury and to restore cerebral perfusion adhering to syncope
  • If FLULAVAL® QUADRIVALENT or FLUARIX® QUADRIVALENT is administered to immunosuppressed persons, including people receiving immunosuppressive therapy, the immune response might be lesser compared to in immunocompetent persons
  • In clinical trials along with FLULAVAL® QUADRIVALENT, the most common solicited local edge reaction in adults was pain. The most common solicited systemic edge reactions in adults were muscle aches, headache, fatigue, and arthralgia. In kids 3 through 17 years of age, the most common solicited local edge reaction was pain. In kids 3 through 4 years of age, the most common solicited systemic edge reactions were irritability, drowsiness, and loss of appetite. In kids five through 17 years of age, the most common solicited systemic edge reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms. (See edge Reactions section of the Prescribing post for FLULAVAL® QUADRIVALENT for various other potential edge reactions and events)
  • In clinical trials along with FLUARIX® QUADRIVALENT, the most common injection site edge reaction in adults was pain. The most common systemic edge reactions in adults were muscle aches, headache, and fatigue. In kids 3 through 17 years of age, injection site edge reactions were pain, redness, and swelling. In kids 3 through 5 years of age, the most common systemic edge reactions were drowsiness, irritability, and loss of appetite. In kids six through 17 years of age, the most common systemic edge reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms. (See edge Reactions section of the Prescribing post for FLUARIX® QUADRIVALENT for various other potential edge reactions and events)
  • Vaccination along with FLULAVAL® QUADRIVALENT or FLUARIX® QUADRIVALENT Might not result in protection in all of vaccine recipients

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to enhancing the quality of human life by enabling people to do more, feel much better and live longer.  For further post please visit www.gsk.com.

GSK enquiries:

UK Media enquiries:

David Mawdsley

+44 (0) twenty 8047 5502

(London)

Simon Steel

+44 (0) twenty 8047 5502

(London)

David Daley

+44 (0) twenty 8047 5502

(London)

Catherine Hartley

+44 (0) twenty 8047 5502

(London)

Claire Brough

+44 (0) twenty 8047 5502

(London)

US Media enquiries:

Sarah Alspach

+1 202 71five 1048

(Washington, DC)

Sarah Spencer

+1 21five 751 3335

(Philadelphia)

Mary Anne Rhyne

+1 919 483 0492

(North Carolina)

Jenni Ligday

+1 202 71five 1049

(Washington, DC)

Karen Hagens

+1 919 483 2863

(North Carolina)

Gwynne Oosterbaan

+1 21five 751 7468

(Philadelphia)

Analyst/Investor enquiries:

Ziba Shamsi

+44 (0) twenty 8047 5543

(London)

Tom Curry

+ 1 21five 751 5419

(Philadelphia)

Gary Davies

+44 (0) twenty 8047 5503

(London)

James Dodwell

+44 (0) twenty 8047 2406

(London)

Jeff McLaughlin

+1 21five 751 7002

(Philadelphia)

 

Cautionary statement concerning forward-looking statements
GSK cautions investors that any type of forward-looking statements or projections gained by GSK, including those gained in this announcement, are subject to risks and uncertainties that Might trigger actual outcomes to differ materially from those projected. Such factors include, however 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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SOURCE GSK

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