Influenza Vaccine, Live Intranasal

Influenza vaccine, Live Intranasal may prevent influenza illness (flu) that may occur with infection due to the influenza virus.

Flu is a contagious disease that spreads around the United States every year, usually between October and May. Anyone can get the flu, but it is more dangerous for some people. Flu can cause fever and chills, sore throat, muscle aches, fatigue, cough, headache, and runny or stuffy nose. Flu can cause other complications such as sinus infections and pneumonia and can lead to hospitalization and death.

Influenza Vaccine, Live Intranasal does a weakened version of the influenza virus. It works by triggering your immune system to build a defense to the influenza virus when it comes in contact with the full virus.

There are many variants of the influenza virus and the vaccine will need to be reformulated periodically to cover the current circulating variants.

Influenza Vaccine, Live Intranasal comes as a solution to be given intranasally (into the nostril) by a healthcare provider or a patient at home.

Influenza Vaccine, Live Intranasal is given as a single dose each season. Certain patients may be recommended to receive 2 doses of the Influenza Vaccine, Live Intranasal based on age and prior vaccine status. If you are recommended to receive 2 doses, they should be given at least 1 month apart.

The Influenza Vaccine Live Intranasal comes as a nasal spray bottle containing one dose. Half of the bottle is administered into each nostril. If you will be giving yourself the dose, you will receive Instructions for Use. Read these instructions very carefully and follow the steps closely. Ask your doctor or pharmacist if you have any questions about how to give Influenza Vaccine, Live Intranasal.

Tell your vaccine provider if you:

• have had an allergic reaction to this vaccine, any part of this vaccine, any other vaccine or any drug, food or substance. Tell your vaccine provider about the allergy and what symptoms you had.
• have or have had asthma or any other respiratory illness, have a history of Guillain-Barre Syndrome (GBS; a rare autoimmune disorder that affects the peripheral nerve system and can be triggered by infections), or weakened immune system from a condition or medication you are receiving.
• have a fever or are feeling unwell.
• are taking aspirin.
• are pregnant or breastfeeding.

In some cases, your health care provider may decide to postpone vaccination to a future visit.

Side effects that have been reported with the Influenza Vaccine, Live Intranasal include:

• runny nose, nasal congestion
• decreased appetite
• irritability
• tiredness
• sore throat
• headache
• muscle aches, chills, fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• wheezing, shortness of breath, difficulty breathing
• numbness in the extremities, muscle pain, difficulty walking or standing, paralysis
• rash, shortness of breath or difficulty breathing, swelling of face or throat

Adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Your health care provider will usually file this report, or you can do it yourself. Visit https://vaers.hhs.gov or call 1-800-822-7967. VAERS is only for reporting reactions, and VAERS staff members do not give medical advice.

• Read the Vaccine Information Sheet (VIS) that your vaccine provider will give you or you can obtain it at https://www.cdc.gov/vaccines/hcp/current-vis/index.html
• Ask your healthcare provider.
• Call your local or state health department.

• Flumist^®