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The Food and Drug Administration has approved influenza vaccines for the 2010-2011 flu season that protect against three influenza strains, including the 2009 H1N1 virus, the agency announced July 30.
Last year, two separate vaccines were needed to protect against seasonal influenza and H1N1, respectively, because H1N1 emerged after the season’s supply of flu vaccine had already been produced. But the upcoming flu season’s supply of vaccines will incorporate protection against H1N1, as well as two other influenza strains.
The vaccine will contain these strains:
–A/California/7/09 (H1N1)-like virus (pandemic [H1N1] 2009 influenza virus)
–A/Perth/16/2009 (H3N2)-like virus
–B/Brisbane/60/2008-like virus.
In a written statement, the FDA said that one vaccine, Afluria (manufactured by CSL Ltd.), recently had its label changed to warn of an increased incidence of febrile seizure and fever. The symptoms were observed mostly in children younger than age 5 years after it was administered in the Southern Hemisphere this year. Because of this, Afluria will be distributed only in 0.5-mL single-dose, prefilled syringes, and via 5-mL multidose vials; the 0.25-mL dose used in very young children will not be administered in the United States. The FDA is requiring CSL to conduct further studies to gather more information on the febrile problems observed in the Southern Hemisphere.
Other vaccine brand names and manufacturers of influenza vaccines for the 2010-2011 season listed in the agency statement are Agriflu by Novartis Vaccines and Diagnostics, Fluarix by GlaxoSmithKline Biologicals, FluLaval by ID Biomedical Corp., FluMist by MedImmune Vaccines Inc., Fluvirin by Novartis Vaccines and Diagnostics Limited, and Fluzone and Fluzone High-Dose by Sanofi Pasteur Inc.
Issuing guidelines that are effective during the 2010-2011 influenza season, the Centers for Disease Control and Prevention recommends that everyone aged 6 months of age and older get an annual influenza vaccine. Until now, vaccination was mainly recommended for people at higher risk of influenza complications, children aged 6 months to 18 years old, and those who had close contact with people at high risk for complications of the illness.
“The best way to protect yourself and your family against influenza is to get vaccinated every year,” said Dr. Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a new seasonal influenza vaccine each year is an important tool in the prevention of influenza related illnesses and death.”
The Food and Drug Administration has approved influenza vaccines for the 2010-2011 flu season that protect against three influenza strains, including the 2009 H1N1 virus, the agency announced July 30.
Last year, two separate vaccines were needed to protect against seasonal influenza and H1N1, respectively, because H1N1 emerged after the season’s supply of flu vaccine had already been produced. But the upcoming flu season’s supply of vaccines will incorporate protection against H1N1, as well as two other influenza strains.
The vaccine will contain these strains:
–A/California/7/09 (H1N1)-like virus (pandemic [H1N1] 2009 influenza virus)
–A/Perth/16/2009 (H3N2)-like virus
–B/Brisbane/60/2008-like virus.
In a written statement, the FDA said that one vaccine, Afluria (manufactured by CSL Ltd.), recently had its label changed to warn of an increased incidence of febrile seizure and fever. The symptoms were observed mostly in children younger than age 5 years after it was administered in the Southern Hemisphere this year. Because of this, Afluria will be distributed only in 0.5-mL single-dose, prefilled syringes, and via 5-mL multidose vials; the 0.25-mL dose used in very young children will not be administered in the United States. The FDA is requiring CSL to conduct further studies to gather more information on the febrile problems observed in the Southern Hemisphere.
Other vaccine brand names and manufacturers of influenza vaccines for the 2010-2011 season listed in the agency statement are Agriflu by Novartis Vaccines and Diagnostics, Fluarix by GlaxoSmithKline Biologicals, FluLaval by ID Biomedical Corp., FluMist by MedImmune Vaccines Inc., Fluvirin by Novartis Vaccines and Diagnostics Limited, and Fluzone and Fluzone High-Dose by Sanofi Pasteur Inc.
Issuing guidelines that are effective during the 2010-2011 influenza season, the Centers for Disease Control and Prevention recommends that everyone aged 6 months of age and older get an annual influenza vaccine. Until now, vaccination was mainly recommended for people at higher risk of influenza complications, children aged 6 months to 18 years old, and those who had close contact with people at high risk for complications of the illness.
“The best way to protect yourself and your family against influenza is to get vaccinated every year,” said Dr. Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a new seasonal influenza vaccine each year is an important tool in the prevention of influenza related illnesses and death.”
The Food and Drug Administration has approved influenza vaccines for the 2010-2011 flu season that protect against three influenza strains, including the 2009 H1N1 virus, the agency announced July 30.
Last year, two separate vaccines were needed to protect against seasonal influenza and H1N1, respectively, because H1N1 emerged after the season’s supply of flu vaccine had already been produced. But the upcoming flu season’s supply of vaccines will incorporate protection against H1N1, as well as two other influenza strains.
The vaccine will contain these strains:
–A/California/7/09 (H1N1)-like virus (pandemic [H1N1] 2009 influenza virus)
–A/Perth/16/2009 (H3N2)-like virus
–B/Brisbane/60/2008-like virus.
In a written statement, the FDA said that one vaccine, Afluria (manufactured by CSL Ltd.), recently had its label changed to warn of an increased incidence of febrile seizure and fever. The symptoms were observed mostly in children younger than age 5 years after it was administered in the Southern Hemisphere this year. Because of this, Afluria will be distributed only in 0.5-mL single-dose, prefilled syringes, and via 5-mL multidose vials; the 0.25-mL dose used in very young children will not be administered in the United States. The FDA is requiring CSL to conduct further studies to gather more information on the febrile problems observed in the Southern Hemisphere.
Other vaccine brand names and manufacturers of influenza vaccines for the 2010-2011 season listed in the agency statement are Agriflu by Novartis Vaccines and Diagnostics, Fluarix by GlaxoSmithKline Biologicals, FluLaval by ID Biomedical Corp., FluMist by MedImmune Vaccines Inc., Fluvirin by Novartis Vaccines and Diagnostics Limited, and Fluzone and Fluzone High-Dose by Sanofi Pasteur Inc.
Issuing guidelines that are effective during the 2010-2011 influenza season, the Centers for Disease Control and Prevention recommends that everyone aged 6 months of age and older get an annual influenza vaccine. Until now, vaccination was mainly recommended for people at higher risk of influenza complications, children aged 6 months to 18 years old, and those who had close contact with people at high risk for complications of the illness.
“The best way to protect yourself and your family against influenza is to get vaccinated every year,” said Dr. Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a new seasonal influenza vaccine each year is an important tool in the prevention of influenza related illnesses and death.”