PHILADELPHIA, July 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (

) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released the first lots of FluLaval® [Influenza Virus Vaccine] allowing distribution in the U.S. to begin for the 2010-2011 flu season. GSK anticipates distribution of Fluarix® [Influenza Virus Vaccine] to follow in the next several weeks.

GSK expects to supply more than 30 million doses combined of FLULAVAL and FLUARIX this flu season. FLULAVAL is approved for use in adults (18 years of age and older) to help protect against influenza disease. FLUARIX is approved for use in adults and children (3 years of age and older).
 

Earlier this year, vaccine experts at the Centers for Disease Control and Prevention (CDC) recommended that individuals six months and older should get a flu vaccine each year. The 2010-2011 flu vaccine will offer protection against the 2009 H1N1 pandemic virus and two other flu viruses.
 

"The spread of seasonal flu remains an important public health issue and takes the lives of approximately 36,000 people each year," said Peter Lammers, Vice President, U.S. Vaccines, GlaxoSmithKline. "GSK is proud to provide millions of doses of flu vaccine in preparation for this year's flu season and in support of the government's goal to expand flu vaccination."
 

About Flu
 

The flu, or influenza, is primarily passed from one person to another through the air by droplets released when an infected individual coughs or sneezes, but may also be spread by direct contact with flu virus-contaminated surfaces.
 

According to the CDC, annual flu vaccination is the most effective method for preventing flu virus infection and its complications. CDC's Advisory Committee on Immunization Practices (ACIP) voted for "universal" flu vaccination in the U.S. to expand protection against the flu to more people.
 

The beginning, severity and length of the flu season can vary widely from year to year. While influenza outbreaks can happen as early as October, most of the time influenza activity peaks in January or later. In general, healthcare providers should begin offering vaccination soon after the vaccine becomes available. The CDC recommends that individuals receive their flu vaccinations as soon as it is available from their healthcare provider.
 

  Important Safety Information for FLUARIX
  --  Do not administer FLUARIX to anyone with known systemic
      hypersensitivity reactions to egg proteins (a vaccine component) or a
      life-threatening reaction to previous administration of any influenza
      vaccine
  --  If FLUARIX is administered to immune-suppressed persons, including
      individuals receiving immunosuppressive therapy, the immune response
      may be lower than in immune-competent persons
  --  If Guillain-Barre syndrome has occurred within six weeks of receipt of
      prior influenza vaccine, the decision to give FLUARIX should be based
      on careful consideration of the potential benefits and risks
  --  The tip caps of the prefilled syringes contain natural rubber latex
      which may cause allergic reactions in latex sensitive individuals
  --  In clinical trials with FLUARIX, the most common adverse events in
      adults included injection site pain and redness, muscle aches, fatigue
      and headache. Most adverse events in adult clinical trials were mild
      and self-limited. In children 5 years to <18 years of age, the most
      common adverse events were similar to those in adults but also
      included injection site swelling. In children 3 years to <5 years of
      age, the most common adverse events included pain, redness, and
      swelling at the injection site, irritability, drowsiness, loss of
      appetite and fever. (See adverse reactions section of the Prescribing
      Information for FLUARIX for other potential adverse events)
  --  Vaccination with FLUARIX may not protect 100% of susceptible
      individuals

  Important Safety Information for FLULAVAL
  --  FLULAVAL should not be administered to anyone with known systemic
      hypersensitivity reactions to eggs, egg products, egg or chicken
      proteins, or any component of FLULAVAL
  --  FLULAVAL should not be administered to anyone who has had 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 FLULAVAL should be based
      on careful consideration of the potential benefits and risks
  --  In comparator-controlled clinical trials with FLULAVAL, adverse events
      included pain and redness at the injection site, muscle aches and
      fatigue. Most adverse events in clinical trials were mild and
      self-limited  (See adverse reactions section of the Prescribing
      Information for FLULAVAL for other potential adverse events)
  --  Vaccination with FLULAVAL may not protect 100% of susceptible
      individuals

  GlaxoSmithKline: A Leader in Influenza Vaccine Manufacturing