logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Okays Glaxo's Second Four-strain Seasonal Influenza Vaccine For Use In U.S.

British drug giant GlaxoSmithKline Plc (GSK, GSK.L) announced Friday that the U.S. Food and Drug Administration or FDA has approved Flulaval Quadrivalent (Influenza Virus Vaccine) for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.

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.

"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.

FluLaval Quadrivalent is the second similar vaccine from GlaxoSmithKline that has been approved for the same indications after the FDA approval for its Fluarix Quadrivalent vaccine in mid-December 2012, which was the first-ever intramuscular influenza vaccine approved by the FDA that protects against four influenza strains.

Both the vaccines, Flulaval Quadrivalent and Fluarix Quadrivalent, are also the first to be approved for use by the FDA for children three years of age and older as well as for adults. Previously, GSK's FluLaval Trivalent vaccine (cover against three influenza strains) was limited for administration to individuals 18 and older.

"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," Friedland added.

Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year globally. Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalizations.

Fluarix Quadrivalent is expected to be available in time for the 2013-14 flu season as healthcare providers traditionally order flu vaccines months in advance of each flu season. Meanwhile, GSK expects to making only a limited amount of FluLaval Quadrivalent available this influenza season.

GSK noted that it will have the capacity to supply substantial quantities of both the quadrivalent influenza vaccine shots to the U.S. from the beginning of 2014. FluLaval Quadrivalent will be available in multi-dose vials, while Fluarix Quadrivalent is available in pre-filled syringes.

FluLaval Quadrivalent and Fluarix Quadrivalent are not currently approved or licensed in any country outside of the U.S.

In Friday's regular trading session, GSK is currently trading at $51.56, up $0.03 or 0.06% on a volume of 0.66 million shares. Meanwhile, GSK.L is trading on the LSE at 1,651.00 pence, down 6.50 pence or 0.39% on a volume of 4.32 million shares.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Hampton Farms has voluntarily recalled Ava's brand organic cashews for potential Listeria contamination. The Organic Cashews Roasted & Salted 8 oz. tubs were distributed in New Jersey, New York, Pennsylvania and Connecticut. As per the recall statement, fewer than 225 units of this product were offered for retail sale. Maternity leave is a temporary period of absence from employment granted to expectant or new mothers during the months immediately before and after their pregnancy. Parental leave, including maternity, paternity and adoption leave, is an employee benefit. Many countries around the world, including... Texas, the second largest state in the U.S., has four of the five fastest-growing cities in the U.S., according to new population estimates released Thursday by the U.S. Census Bureau for the twelve months up to July 1, 2016. Ten of the fifteen fastest growing large U.S. cities during that 12-month span were in the South, according to the Census Bureau.
comments powered by Disqus
Follow RTT