GSK receives FDA approval for expanded indication for FluLaval® Quadrivalent (Influenza Vaccine) for infants 6 months and older (1)

Issued in NC

GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval^® Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older.

“The flu is a serious disease with a significant impact on public health and can lead to thousands of deaths in the US every flu season,” said Patrick Desbiens, Senior Vice President, US Vaccines. “Children are particularly at risk from complications associated with flu, and vaccination is the best way parents can help protect them against this serious illness. This expanded indication builds upon GSK’s commitment to influenza vaccines and its legacy as the first manufacturer to bring quadrivalent (four-strain) flu vaccines to the US market.”

Before the approval of an expanded age indication for FluLaval^® Quadrivalent, providers who preferred prefilled syringes had to order and stock two separate influenza vaccines to be able to immunize all patients. With this approval, providers are now able to use the same dose of FluLaval^® Quadrivalent (15ug of hemagglutinin per virus strain in 0.5 mL) to vaccinate all recommended persons aged 6 months and older.

The supplemental Biologics License Application was based on one Phase III pivotal study and three supportive clinical studies conducted in children 6 months through 35 months of age.

For more information about quadrivalent vaccines, visit ChooseMoreChooseFour.com.

About Seasonal Influenza in Children

Seasonal influenza (the “flu”) is a contagious respiratory illness, caused by flu viruses. There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness. Most flu activity in the US occurs from October-May, and it usually peaks in January and February.

According to the US Centers for Disease Control and Prevention (CDC), the flu is more dangerous than the common cold for children. Severe flu complications are most common in children under the age of 2 years. Each year, many children get sick with seasonal influenza and some of those illnesses result in death. On average, 20,000 children under the age of 5 are hospitalized because of influenza complications. The CDC recommends that everyone aged 6 months and older get a seasonal flu vaccine.

For more information about flu, visit www.flu.gov and www.cdc.gov/flu.

About FluLaval® Quadrivalent (Influenza Vaccine)

FluLaval^® Quadrivalent was first approved in 2013 in the U.S. for the prevention of influenza disease in people three years of age and older. In addition, it is also approved in two other countries, Canada (as FluLaval^® Tetra) and Mexico (as FluZactal^® Tetra), for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine in people 6 months of age and older.

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 children (6 months and older) and adults.

Important Safety Information for FluLaval^® Quadrivalent (Influenza Vaccine)

• Do not administer FluLaval^® Quadrivalent to anyone with a history of  severe allergic reactions (e.g., 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 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 FluLaval^® Quadrivalent. 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 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 aged 6 through 35 months of age, the most common 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 FluLaval^® Quadrivalent may not result in protection in all vaccine recipients.

For the full US Prescribing Information for FluLaval^® Quadrivalent, please see our press kit available here.

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.