2012-2013 Flu Strain Vaccinations Get Approval By The FDA
August 15, 2012

2012-2013 Flu Strain Vaccinations Get Approval By The FDA

Lawrence LeBlond for redOrbit.com - Your Universe Online

A US federal regulator has issued approvals for the 2012-2013 seasonal flu vaccines on Monday. The vaccines are based on strains currently circulating the world, including the same H1N1 “swine flu” strain from the past two years, and also two new strains for viruses that we have no protection against.

The Food and Drug Administration (FDA) approved the vaccines for all six manufacturers licensed to produce and distribute the vaccines in the United States. These include: CSL Limited, which manufactures Afluria; GlaxoSmithKline, which produces Fluarix; ID Biomedical Corp. which makes FluLaval; FluMist by MedImmune Vaccines; Fluvirin by Novartis Vaccines and Diagnostics Limited; and Sanofi Pasteur´s Fluzone, Fluzone High-Dose and Fluzone Intradermal.

Every year experts from the FDA, World Health Organization (WHO), and the Centers for Disease Control and Prevention (CDC), as well as other experts, study influenza virus samples and global disease patterns to identify virus strains likely to cause the most illnesses during the upcoming flu season.

Based on the information gleaned from the studies, and recommendations from the FDA´s Vaccines and Related Biological Products Advisory Committee, this year´s vaccine includes protections against the following strains: A/California/7/2009 (H1N1)-like virus; A/Victoria/361/2011 (H3N2)-like virus; and B/Wisconsin/1/2010-like virus.

While the H1N1 virus is the same as what was included in the 2011-2012 influenza vaccines, the CDC is urging everyone to get the vaccine because those who were immunized last year do not carry protection from the latter two strains included in this year´s shot. The CDC did say that “everyone” includes all individuals over six months of age, but not those with severe egg allergies or who have had a severe reaction to previous flu vaccinations.

Of those who can get it, the CDC urges that pregnant women, young children and seniors do so, as they are at higher risk of developing life-threatening complications from the flu.

“The best way to prevent influenza is by getting vaccinated each year,” said Karen Midthun, M.D., director of the FDA´s Center for Biologics Evaluation and Research. “It is especially important to get vaccinated this year because two of the three virus strains used in this season´s influenza vaccines differ from the strains included in last year´s vaccines.”

From 5 to 20 percent of the US population develop some form of the flu every year, according to figures from the CDC. More than 200,000 hospitalizations occur each year from related complications. It is difficult to predict seasonal flu, which can be severe, with annual influenza-related deaths ranging from 3,000 to 49,000 people in the US.

Healthcare providers are an important link in protection from the flu and should make sure they get vaccinated each year. They should also make sure their patients, families, friends, and everyone in the community protect themselves from influenza by getting the vaccinations as well.

Clinics, doctor´s offices, pharmacies and other participating vendors should start offering the vaccine beginning in the early fall. Some vaccines that are being offered earlier may not contain protection from this year´s strains.

Learn more about the flu at Flu.gov.