PHILADELPHIA, Nov. 21, 2016 /PRNewswire/ -- 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.
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.
|
Registered in
England & Wales:
No.
3888792
|
|
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8 9GS
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/gsk-receives-fda-approval-for-expanded-indication-for-flulaval-quadrivalent-influenza-vaccine-for-infants-6-months-and-older-300366488.html
SOURCE GSK