Second GSK intramuscular quadrivalent influenza vaccine approved by the FDA

GlaxoSmithKline plc [LSE/NYSE: GSK] announced that the U.S. Food and Drug Administration (FDA) has approved FLULAVAL® QUADRIVALENT (Influenza Virus Vaccine) for the active immunization of persons three years of age and older to help prevent disease caused by seasonal influenza (flu) virus subtypes A and B contained in the vaccine. This is the second GSK intramuscular quadrivalent influenza vaccine approved by the FDA. GSK’s Fluarix Quadrivalent was the first-ever intramuscular influenza vaccine approved by the FDA in December 2012, and is now shipping to customers.

“Since the late 1980s, public-health authorities have known that four primary influenza strains circulate each year causing the majority of influenza illness, but the influenza vaccines used for the past thirty years only covered against three strains,” said Dr. Leonard Friedland, V.P., Director, Scientific Affairs and Public Health, GSK Vaccines North America. “With this limitation, global influenza experts have had to make a difficult determination around the strains each season to cover, and in six of the past 11 influenza seasons (2001-2012), one of the predominant strains was not included in the season’s influenza vaccines. Trivalent vaccines do reduce influenza risk even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage.”

Scientists classify the influenza strains that cause seasonal influenza as A or B strains. Influenza vaccines have been used in the U.S. for more than fifty years, most recently in the trivalent (three-strain) form to help protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year. Yet two distinct B virus strains (Victoria and Yamagata) co-circulate to varying degrees each influenza season. FluLaval Quadrivalent helps protect against the two A strains and B strains, decreasing influenza-related morbidity across all age groups – children, adults and the elderly.

Beginning in 2014, GSK will have the capacity to supply the U.S. substantial quantities of quadrivalent influenza vaccine shots manufactured in Quebec, Canada (FluLaval Quadrivalent); and Dresden, Germany/Marietta, Pa. (Fluarix Quadrivalent). Additionally, today’s approval marks the first time that all GSK influenza vaccine shots are approved for use by the FDA for children three years of age and older as well as for adults. FluLaval Trivalent vaccine was previously limited for administration to individuals 18 and older. The availability of FluLaval Quadrivalent gives GSK the capability to meet the needs of healthcare providers who prefer to stock multi-dose vials of influenza vaccines. FluLaval Quadrivalent will be available in multi-dose vials, while Fluarix Quadrivalent is available in pre-filled syringes.

GSK anticipates making a limited amount of FluLaval Quadrivalent available this influenza season and will immediately begin taking order reservations on http://gskvaccinesdirect.com. Most healthcare providers order influenza vaccine months ahead of the current season, though some in season demand typically occurs. FluLaval Quadrivalent is not currently approved or licensed in any country outside of the U.S. The full U.S. Prescribing Information will be available on http://www.gsk.com/products/index.htm.

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 shot annually. More information about seasonal influenza can be found at http://flu.gov and http://www.cdc.gov/flu/about/season/flu-season-2012-2013.htm.

Important Safety Information 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.

Do not administer FluLaval 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 prior influenza vaccine, the decision to give 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. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

If 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 FLULAVAL QUADRIVALENT, the most common solicited local adverse reactions in adults was pain. The most common solicited systemic adverse reactions in adults were muscle aches, headaches, fatigue and arthralgia. In children 3 years through 17 years of age, the most common solicited local adverse reactions 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 FluLaval 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, go to us.gsk.com, follow us on twitter.com/GSKUS or visit our U.S. company blog.