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Flu Vaccine: FDA Makes Sure There Is Enough

A Ready Supply of Influenza Vaccine

Each year, FDA plays a key role in protecting Americans against seasonal influenza. Making sure there is enough vaccine for everyone who wants it—especially for people with the greatest need for it—is one of the agency's highest priorities.

Meeting demand for the vaccine requires collaboration between FDA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the World Health Organization, and companies that manufacture it.

Seasonal influenza—or flu—is a contagious respiratory illness caused by viruses. Symptoms include fever, headache, body aches, chills, extreme exhaustion and weakness.

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.

How Flu Gets Around

Flu is spread through coughing or sneezing. You can also become infected by touching objects that are carrying the virus, such as telephones and door knobs, and then touching your mouth or nose.

Most healthy adults may be able to infect others one day before their own symptoms develop, and up to five days after becoming sick.

"Yearly immunization is the most effective way to prevent influenza and decrease influenza-related complications, which can include serious illness and death," says Jesse L. Goodman, M.D., M.P.H., Director of FDA's Center for Biologics Evaluation and Research.

Best Times to Immunize

It's best to be immunized as soon as the vaccine is available, usually in September. But getting vaccinated during winter months, when influenza season often peaks, is not too late and is also recommended.

Public health experts suggest that high-risk individuals be immunized first. This group includes, but is not limited to, the elderly, young children, and people with weakened immune systems or chronic diseases.

There are two kinds of influenza vaccines:

  • the flu shot, which contains inactivated, or killed, influenza viruses.
  • nasal vaccine, which is known by the trade name of FluMist. It contains weakened, live viruses, and is sprayed into both nostrils.

Preparation for the 2007-2008 flu season began last year when influenza virus strains judged likely to cause seasonal flu in the Northern Hemisphere were selected for inclusion in the vaccine. Every year, FDA works with other federal agencies, influenza experts and international organizations to select the strains.

More Vaccine Than Ever

Two recent FDA approvals have assured that more vaccine is available this year than ever before.

On Sept. 19, 2007, the Agency approved expanding the use of FluMist to children between the ages of 2 and 5. Previously, the vaccine was limited to healthy children 5 years and older. Adults up to age 49 can also use the vaccine.

FDA approved Afluria for adults 18 and older on Sept. 28, 2007. This new vaccine for the U.S. market, manufactured by CSL Limited of Australia, brings to six the number of seasonal influenza manufacturers licensed for the U.S.

Using current manufacturing trends, CDC estimates that a record 132 million doses of influenza vaccine will be available for this flu season, but these projections could change as manufacturing continues.

Licensed Influenza Vaccines, 2007-2008:

  • Fluarix, for use by people ages 18 and older.
  • FluLaval, for use by people ages 18 and older
  • Afluria, for use by people ages 18 and older
  • Fluvirin, for people ages 4 and older.
  • Fluzone, for people 6 months and older.
  • FluMist, for people ages 2 to 49.

Source: Consumer Update, FDA.

Date Posted: October 23, 2007.

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