Late-breaking news: FDA approves vaccines for the 2011 to 2012 influenza season

July 19, 2011

FDA has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the 6 manufacturers licensed to produce and distribute influenza vaccine for the United States.

FDA has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the 6 manufacturers licensed to produce and distribute influenza vaccine for the United States.

According to the Centers for Disease Control and Prevention (CDC), flu season can be severe. For the 30-year period between 1976 and 2006, estimates of annual flu-associated deaths in the United States range from a low of about 3,000 to a high of about 49,000 people.

Certain people are at greater risk for serious complications if they get the flu. This includes older people, young children, pregnant women, people with certain health conditions (such as asthma, diabetes, or heart disease), and persons who live in facilities such as nursing homes.

Vaccination remains the cornerstone of influenza prevention. The vaccine formulation protects against the 3 virus strains that surveillance indicates will be most common during the upcoming season and includes the same virus strains used for the 2010- 2011 influenza season.

Between 5% and 20% of the US population develops influenza each year, leading to more than 200,000 hospitalizations from related complications, according to the CDC.

The brand names and manufacturers of the vaccines for the upcoming season are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone, Fluzone High-Dose and Fluzone Intradermal, Sanofi Pasteur Inc. Fluzone Intradermal, approved on May 9, 2011, will be available for those aged 18 years through 64 years. This vaccine is delivered into the skin, rather than the muscle, using a very small needle.

“What is important for [Drug Topics] readers is to let them know that vaccine has already begun shipping and is expected to be plentiful this year so they should feel confident moving forward to schedule their influenza immunization clinics to implement the CDC recommendation to immunize everyone 6 months of age and older,” Donna K. Cary, Sanofi Pasteur spokeswoman, told Drug Topics.

Sanofi Pasteur has begun shipping its 2011-2012 Fluzone Influenza Virus Vaccine in the United States. This shipment represents the first of approximately 70 million doses of seasonal influenza vaccine that the company plans to deliver in the upcoming season. The shipment will include Fluzone High-Dose vaccine, which will be widely available this season for adults aged 65 years of age and older, an age group among the hardest hit by influenza.

“Fluzone High-Dose vaccine is designed to address the immunization needs of those over 65 years of age, who typically have weaker immune responses to vaccination,” said Cary.

Additionally, shipment of Fluzone Intradermal vaccine, approved by FDA this past May, will follow to offer adults 18 to 64 years of age a new immunization option this flu season.

Fluzone Intradermal vaccine, a new microinjection, “will be an attractive immunization option for adults 18 through 64 years of age and their healthcare providers due to the microneedle and ease of administration,” according to Cary. “If it is well accepted, we hope as a result we may help increase the low immunization rates in this age group.”

Each year, experts from FDA, World Health Organization, CDC, and others in the public health community study virus samples and patterns collected worldwide to identify virus strains likely to cause the most illness during the upcoming influenza season. Based on that information and the recommendations of FDA's Vaccines and Related Biological Products Advisory Committee, the strains selected for the 2011-2012 influenza season are:

  • 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 always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

CDC's Advisory Committee on Immunization Practices recommends that everyone 6 months of age and older receive an annual influenza vaccination.