Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA's accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner.
In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.
According to CDC, between 5 and 20 percent of the U.S. population develops seasonal influenza each year. More than 200,000 people are hospitalized from its complications and about 36,000 people die. The newly approved Agriflu is yet another option to prevent illnesses caused by subtypes A and B influenza virus
• Symptoms of the flu include fever, headache, body aches, chills, extreme exhaustion, and weakness.
• Influenza is spread through coughing or sneezing. You can also get it by touching objects carrying the virus, especially when you then touch your mouth or nose. Such objects include telephones and door knobs.
• Most healthy adults may be able to infect others one day before their own symptoms develop and up to five days after becoming sick.
• Washing your hands often is a key strategy for preventing
influenza. Teach your kids about the importance of hand washing. Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Most people recover from the flu within one to two weeks. But some develop serious complications such as pneumonia, ear infections, sinus infections, dehydration, and worsening of chronic medical conditions such as congestive heart failure, asthma, or diabetes.
"The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.
Common side effects in clinical studies included pain, swelling and redness at the injection site, headache and muscle aches. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated. Agriflu is administered as a single injection in the upper arm.
For more information on the seasonal flu: cdc.gov
Written by Cheryl Phillips
HULIQ.com
sources: cdc.gov
Posted November 27th, 2009 by Cheryl Phillips
