GlaxoSmithKline receives FDA approval to ship four-strain (quadrivalent) influenza vaccine to healthcare providers

PHILADELPHIA, Aug. 5, 2013 /PRNewswire/ -- GlaxoSmithKline [NYSE: GSK] announced today it has received U.S. Food and Drug Administration (FDA) approval to start shipping 2013-2014 FLUARIX^® QUADRIVALENT (Influenza Virus Vaccine) to CDC distribution centers and U.S. healthcare providers. This is the first season that vaccines protecting against more than three strains of influenza (flu) will be commercially available.

Fluarix Quadrivalent was the first intramuscular quadrivalent influenza vaccine approved by the FDA [on December 14, 2012] for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine. Before vaccine manufacturers can begin shipping influenza vaccines each season, the FDA first must certify that the supplies to be provided to healthcare providers meet the agency's quality and safety standards.

Scientists classify the influenza strains that cause seasonal influenza as A or B strains. Most current influenza vaccines provide trivalent (three-strain) influenza protection. Trivalent influenza vaccines protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year.

"Trivalent (three-strain) influenza vaccines offer important protection against influenza. But since the late 1980s, scientists noted that two B virus lineage strains circulate to varying degrees each year, and it's difficult to predict which one will cause the most illness in a particular influenza season," said Dr. Leonard Friedland, VP, Scientific Affairs and Public Policy, GSK Vaccines, North America. "Fluarix Quadrivalent addresses this by protecting against both B strains."

With today's FDA lot release, GSK's Fluarix Quadrivalent influenza vaccine soon will be supplied to U.S. healthcare providers who placed orders for the new vaccine after it was approved late last year. The CDC (U.S. Centers for Disease Control and Prevention) placed the largest order for Fluarix Quadrivalent - for more than four million doses - and will allocate those doses to U.S. state and local healthcare providers. The CDC annually purchases large quantities of influenza vaccines from multiple influenza manufacturers.

For this influenza season, GSK will supplement the supply of Fluarix Quadrivalent with its trivalent seasonal influenza vaccines. In the U.S., GSK estimates it will provide up to 10 million doses of quadrivalent influenza vaccines, and 22 to 24 million doses of influenza vaccines overall. GSK believes the healthcare community will steadily transition in coming years to quadrivalent influenza vaccines, and the company is in the process of increasing its capability to provide substantially more quadrivalent influenza vaccine doses for coming influenza seasons.

Fluarix Quadrivalent also is approved in Germany (marketed as INFLUSPLIT™Tetra^®) and the UK (as FLUARIX™ TETRA). The full U.S. Prescribing Information is available on http://www.gsk.com/products/index.htm.

For a link to the GSK Fluarix Quadrivalent electronic press kit, U.S. journalists can click here.

About Seasonal Influenza
Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalizations. The U.S. Centers for Disease Control and Prevention (CDC) recommends that children six months of age and older and adults receive an influenza vaccine annually. More information about seasonal influenza can be found at http://flu.gov and http://www.cdc.gov/flu/about/season/index.htm.

Important Safety Information 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.

• Do not administer 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-Barre syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Fluarix Quadrivalent should be based on careful consideration of the potential benefits and risks.
• The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals.
• If Fluarix Quadrivalent is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
• 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.
• In clinical trials with Fluarix Quadrivalent, the most common adverse reactions in adults were pain at the injection site, muscle aches, headaches and fatigue. In children 3 years to less than 18 years of age, the most common adverse reactions were pain at the injection site, redness and swelling. In children 3 years to less than 6 years of age, the most common adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 to less than 18 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 Fluarix Quadrivalent may not result in protection in all vaccine recipients.

About GlaxoSmithKline Vaccines
GlaxoSmithKline Vaccines, a division of GlaxoSmithKline group, is the world's leading vaccine company and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Vaccines has 14 manufacturing sites strategically positioned around the globe. In 2011, GSK Vaccines distributed 1.1 billion doses to 173 countries in both the developed and the developing world. Through its accomplished and dedicated workforce, GSK Vaccines applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.

GlaxoSmithKline – 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 http://us.gsk.com/.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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. Factors that may affect GSK's operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.

SOURCE GlaxoSmithKline