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  1. Public Health Focus

Seasonal Flu (Influenza) and the FDA

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Making the flu vaccine

Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Your best defense is vaccination, which provides important protection from flu and its potential complications.

Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Every flu season is different, and the substantial health impacts can 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 in the United States. The FDA plays a key role in making sure flu vaccines are safe, effective, and of high quality.

The FDA is responsible for ensuring 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

a row of seven small glass medical vials containing clear liquid and a medical syringe used for injecting vaccines

CDC: Who Needs a Flu Vaccine and When

The flu viruses that circulate and cause  disease in people often change from one year to another. So, every year, there is a new flu vaccine to protect against the flu viruses that are expected to be prevalent in the United States 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, or inhalers used to prevent or treat flu. They are approved for adults, children and infants as young as two weeks.

•    If you get the flu, antiviral medications can make your illness milder and may 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 provider 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.

Flu and COVID-19

The flu viruses and the virus that causes COVID-19 will likely circulate together this fall and winter.

The flu vaccine will not prevent COVID-19. The flu vaccines are approved by the FDA for the prevention of influenza disease, so getting vaccinated can help keep you out of the doctor’s office and preserve health care resources for patients with other diseases and medical conditions, including COVID-19.

If you think you have the flu or COVID-19, contact your health care provider immediately.

Availability and Shortages

To report a shortage of a flu antiviral drug, send an email to [email protected] or call 888-INFO-FDA (888-463-6332) or 301-796-3400.

To report a shortage of a flu vaccine, send an email to [email protected] 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. Therefore, the Centers for Disease Control and Prevention (CDC) recommend that parents, grandparents, caregivers, and all household members 6 months or older should be vaccinated because they will be less likely to get the flu and spread it to the unvaccinated child. If possible, keep infants away from crowds for the first few months of life.

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