Seasonal Flu (Influenza) and the FDA
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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
- Protect Your Family From Fraudulent Flu Products (Spanish)
- It’s a Good Time to Get Your Flu Vaccine (Spanish)
- FDA's Critical Role in Ensuring Supply of Influenza Vaccine
- Is It a Cold or the Flu? Prevention, Symptoms, Treatments (Spanish)
- Vaccines Protect Children From Harmful Infectious Diseases (Spanish)
Latest Seasonal Flu News
- Influenza Vaccine for the 2020-2021 Season
- Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season (Spanish)
- Podcast: Get Your Flu Vaccine
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, discusses this year's flu season and the importance of getting vaccinated as we continue the fight against the COVID-19 pandemic.
Flu Vaccines
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 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. 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.
Learn more:
- Vaccines Protect Children From Harmful Infectious Diseases (Spanish)
- Questions about Vaccines
- Vaccines for Children - A Guide for Parents and Caregivers (Spanish)
- CDC National Immunization Program