The US FDA (Food and Drug Administration) has approved vaccines for the 2010-2011 USA influenza season, protecting against three strains of influenza, including the H1N1 virus which caused the 2009 pandemic.

In 2009, because the H1N1 virus appeared after seasonal vaccine production commenced, two separate vaccines were required to protect against the seasonal flu and the 2009 H1N1 pandemic flu virus. The FDA says that only one vaccine is needed for this year.

The CDC (Centers for Disease Control and Prevention ) informs that between 5% and 20% of the American population develops influenza annually, resulting in over 200,000 hospitalizations from related complications and about 36,000 deaths.

Karen Midthun, M.D., acting director of FDA’s Center for Biologics Evaluation and Research, said:

The best way to protect yourself and your family against influenza is to get vaccinated every year. The availability of a new seasonal influenza vaccine each year is an important tool in the prevention of influenza related illnesses and death.

The FDA says that it is vital that health care personnel be vaccinated for their own protection, as well as people they come into contact with, such as patients, their family, and the community.

The brand names and manufacturers for the upcoming season’s vaccines are:

  • Afluria (CSL Limited)
  • Agriflu (Novartis Vaccines and Diagnostics)
  • Fluarix (GlaxoSmithKline Biologicals)
  • FluLaval (GlaxoSmithKline Biologicals)
  • FluMist (MedImmune Vaccines Inc. )
  • Fluvirin (Novartis Vaccines and Diagnostics Limited)
  • Fluzone and Fluzone High-Dose (Sanofi Pasteur Inc.)

Each year, experts from FDA, World Health Organization, CDC, and other institutions study virus samples and patterns collected worldwide to identify strains likely to cause the most illness during the upcoming season. Based on that information and the recommendations of FDA’s Vaccines and Related Biological Products Advisory Committee, manufacturers included the respective three strains in the 2010-2011 vaccines. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against influenza disease.

Vaccines for the 2010-2011 seasonal influenza contain the following 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

There is a chance that a match between predicted virus strains and the ones that eventually circulate is not perfect. Nevertheless, even if the vaccine and the circulating strains are not a perfect match, the vaccine may help infected patients experience milder symptoms and have a lower risk of complications, the FDA informs.

The FDA writes that seasonal influenza vaccines have a long and successful track record of safety and effectiveness in the USA.

The labeling for one vaccine, CSL Limited’s Afluria, has undergone changes this season to inform health care providers about an increased incidence of fever and febrile seizure, which was seen in young children, mainly those younger than 5 years, following administration of the 2010 Southern Hemisphere formulation of CSL’s influenza vaccine. The Southern Hemisphere influenza season occurs prior to that of the Northern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.

FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere.

CDC has published recommendations for annual influenza vaccination to include all people aged 6 months and older. The expanded recommendation is to take effect in the 2010-2011 influenza season. The Advisory Committee on Immunization Practices (ACIP), which advises the CDC on vaccine issues, voted on the new recommendation during its February 24, 2010 meeting in Atlanta.

Prior recommendations for seasonal influenza vaccination focused on vaccination of persons at increased risk for complications from influenza including people with underlying health conditions, children 6 months through 18 years of age, and close contacts of high risk persons among others.

The new recommendations can be found at here.

Source: FDA

Written by Christian Nordqvist