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Seasonal Flu (Influenza) and the FDA

Making the flu vaccine


Influenza (flu) is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Your best defense against influenza disease is to get a flu vaccine every year.

Flu viruses typically spread in fall and winter, with activity peaking between December and February. Every flu season is different, and the health impacts can be substantial and vary widely from season to season, with some flu seasons being worse than others.

Flu viruses can change from year to year, so the vaccine is updated every year to protect against new flu virus strains that are expected to circulate and cause illness in the U.S. The FDA plays a key role in making sure flu vaccines are safe, effective, and of high quality.

The FDA is responsible for ensuring that the supply of the following is safe and effective:

To find out the latest information on the seasonal flu, go to Flu.gov. (Spanish)

Consumer Information

Latest Seasonal Flu News

Flu Vaccines

The flu viruses that circulate and cause disease in people often change from one year to another. Every year there is a new flu vaccine to protect against the flu viruses that are expected to be prevalent in the U.S. during the upcoming flu season. Therefore, it is important for you to get vaccinated every year.

For in-depth information from the FDA on flu vaccines, see Influenza Virus Vaccine Safety & Availability.

Flu Antiviral Drugs

Flu antiviral medications are prescription pills, liquids, and inhalers used to prevent or treat flu. They are approved for adults, children and infants as young as 2 weeks.

  • If you get the flu, antiviral medications can make you feel better faster. Antiviral medications work best when started within the first two days of getting sick.
  • If you are exposed to the flu, antiviral medication can help prevent you from becoming sick.

Talk to your health care professional if you have been or may be near a person with the flu.

For in-depth information from the FDA on flu antiviral drugs, see Influenza (Flu) Antiviral Drugs and Related Information.

Availability and Shortages

The FDA tracks the availability of antiviral medications every flu season. To report a shortage of a flu antiviral drug, send an email to drugshortages@fda.hhs.gov or call 888-INFO-FDA (888-463-6332) or 301-796-3400.

To report a shortage of a flu vaccine, send an email to CBERshortage@fda.hhs.gov or call 240-402-8380.

Children and Flu

Although children younger than 6 months are too young to be vaccinated, they have the highest risk for being hospitalized because of flu and flu-related complications compared to children of other ages. The Centers for Disease Control and Prevention recommends that parents, grandparents, caregivers, and all household members age 6 months and older be vaccinated. If possible, keep infants away from crowds for the first few months of life.

Learn more:


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