START with a live attenuated vaccine1‑3

FluMist Quadrivalent is engineered to help prevent influenza, not cause it.1 To learn more, click to open each section below.

Natural Immune Response

FluMist Quadrivalent expresses the same surface antigens as the influenza virus1‑3

  • The influenza virus contains the 2 antigens of influenza viruses, known as neuraminidase (NA) and hemagglutinin (HA)1,2
    • HA is responsible for attachment of the influenza virus1,2
    • NA is responsible for replication of the influenza virus1,2
  • With at least five attenuating points in each strain, the odds of reversion to wild-type influenza are 1 in 100,000,000,000,000,000,000 (1 in 100 quintillion) replication cycles (1x1020 replication cycles), more than a millennium in time4,5
FluMist Quadrivalent resembles the flu virus to help the body elicit an immune response similar to the body's natural response to influenza1‑3

Live Attenuated Vaccine

The live attenuated influenza virus strains in FluMist Quadrivalent are:

Attenuated

The disease-causing properties are modified and cannot cause influenza 1

Cold-Adapted

The virus strains replicate efficiently in the cooler areas of the nasopharynx at 25°C to initiate an immune response in the nose1

Temperature-Sensitive

The virus strains do not replicate in the lungs where infection occurs1

The virus strains in FluMist Quadrivalent continuously replicate in the lining of the nasopharynx for up to 28 days to induce immunity1,6,7

With FluMist Quadrivalent, viral replication is necessary to induce an immune response1,6

Shedding transmission

Replication = Shedding

Viral replication is necessary for the vaccine to work1,6,7

  • Viral shedding occurs as FluMist Quadrivalent strains replicate in the nasopharynx of the recipient after vaccination1,6,7
  • This is to be expected as a normal immune response1,6,7

Children show the highest rates of shedding1,6,7

  • The amount of vaccine virus shed is inversely proportional to patient age1,6,7
  • Peak shedding typically occurs on day 2 to 31,6,7

Shedding Transmission

Despite shedding, the probability of transmission in children is extremely low1,8

Note: This is not FluMist Quadrivalent data. FluMist Quadrivalent is built on the foundation of trivalent FluMist1

  • A study of 197 children under the age of 36 months in close contact in a daycare setting identified only one case of transmission, which did not result in illness8:
    • The child exhibited runny nose/nasal congestion, irritability, and cough, but nasal swabs tested negative for influenza
    • The transmitted vaccine virus did not revert to wild-type influenza
Transmission with trivalent FluMist® (Influenza Vaccine Live, Intranasal) is extremely low among children in a daycare setting1,8

Transmission illness

Transmission of the live attenuated virus strains in FluMist Quadrivalent does not result in illness in others1,8

Transmission Illness

Shedding can result in transmission, but does not result in illness in others1,8

  • Like the influenza virus, the vaccine virus can also be transmitted to an unvaccinated individual1,8
  • However, the vaccine virus has been engineered not to cause illness1,8
  • The shed virus must regain its ability to replicate at the higher temperatures of the lungs in order for illness to occur4,5
  • The virus must revert back to wild type to produce illness4,5
    • With at least 5 attenuating points in each strain, the odds of reversion to wild-type influenza are 1 in 100,000,000,000,000,000,000 (one in 100 quintillion) replication cycles (1x1020 replication cycles), more than a millennium in time4,5
    • No cases of reversion to wild type have been reported to date1

FluMist Quadrivalent may be used by those eligible recipients who have close contact with immunocompromised persons9

The CDC/ACIP states:
  • People who are in contact with others with severely weakened immune systems, when they are being cared for in a protective environment (e.g., people with hematopoietic stem cell transplants), should not receive LAIV9
  • People who have contact with others with lesser degrees of immunosuppression (e.g., people with diabetes, people with asthma taking corticosteroids, or people infected with HIV) can receive LAIV9

The CDC/ACIP and the AAP State:
  • LAIV is acceptable to use in those eligible persons who have contact with immunocompromised individuals9,10

CDC/ACIP = Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices; AAP = American Academy of Pediatrics;
LAIV = live attenuated influenza vaccine.

Important Safety Information

FluMist® Quadrivalent

FluMist Quadrivalent is a vaccine indicated for active immunization of persons 2‑49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluMist Quadrivalent is for intranasal administration only.

FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction to any vaccine component including egg protein, gentamicin, gelatin and arginine or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

In clinical trials, the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist® (Influenza Vaccine Live, Intranasal). Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing.

If Guillain‑Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks. FluMist Quadrivalent has not been studied in immunocompromised persons. The safety of FluMist Quadrivalent in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications has not been established. FluMist Quadrivalent may not protect all individuals receiving the vaccine.

The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2‑49 years, fever >100°F in children 2‑6 years, and sore throat in adults 18‑49 years. Among children 2‑17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18‑49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat.

Please see complete Prescribing Information for FluMist Quadrivalent, including Patient Information.

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Select safety information

The most common solicited adverse reactions were runny nose or nasal congestion in all persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years.

Click the OPEN tab for Important Safety and Eligibility Information

Important Safety and Eligibility Information

FluMist Quadrivalent is a vaccine indicated for active immunization of persons 2‑49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluMist Quadrivalent is for intranasal administration only.

FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction to any vaccine component including egg protein, gentamicin, gelatin and arginine or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

In clinical trials, the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist® (Influenza Vaccine Live, Intranasal). Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing.

If Guillain‑Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks. FluMist Quadrivalent has not been studied in immunocompromised persons. The safety of FluMist Quadrivalent in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications has not been established. FluMist Quadrivalent may not protect all individuals receiving the vaccine.

The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2‑49 years, fever >100°F in children 2‑6 years, and sore throat in adults 18‑49 years. Among children 2‑17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18‑49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat.

Please see complete Prescribing Information for FluMist Quadrivalent, including Patient Information.