Start with the facts before you start vaccinating with FluMist Quadrivalent.
The live virus strains in FluMist Quadrivalent cause the flu.
FluMist Quadrivalent contains attenuated viral strains in which the disease-causing properties were modified so as not to cause influenza-like illness (ILI). The virus strains are temperature-sensitive, so they have restricted replication at temperatures at which many wild-type influenza viruses grow efficiently.1 The odds of reversion to wild-type influenza are 1 in 100 quintillion replication cycles (1 x 1020 replication cycles). This would take more than 1,000 years to happen.2-4
Viral shedding from a person recently vaccinated with FluMist Quadrivalent will transmit the flu virus.
In clinical studies with trivalent FluMist, transmission of vaccine viruses to close contacts has occurred only rarely. The current estimated risk of getting infected with vaccine virus after close contact with a person vaccinated with FluMist Quadrivalent is low (1%-2%). Because the viruses are weakened, infection is unlikely to result in influenza illness symptoms since the vaccine viruses have not been shown to mutate into typical or naturally occurring influenza viruses.5
All patients in close contact with immunocompromised persons should not receive FluMist Quadrivalent.
Vaccine recipients or their parents/guardians should be informed by the healthcare provider that FluMist Quadrivalent is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.1
According to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (CDC/ACIP), transmission from a recently vaccinated person causing illness in an immunocompromised contact has not, to date, been reported.6
The CDC states that people, including healthcare professionals, who are in contact with individuals with weakened immune systems (e.g., people with diabetes, people with asthma taking corticosteroids, or people infected with HIV) can still get FluMist Quadrivalent.7
All eligible persons can receive FluMist Quadrivalent, except those who are in close contact with severely immunocompromised persons (e.g., hematopoietic stem cell transplants) during those periods when the immunocompromised persons are in a protective environment.7
Healthcare professionals (HCPs) who are pregnant or immunocompromised cannot administer FluMist Quadrivalent.
No instances have been reported of illness or attenuated vaccine virus infections among inadvertently exposed persons. Although the risk for acquiring vaccine viruses from the environment is unknown, the vaccine viruses are temperature-sensitive, cold-adapted, and attenuated and, therefore, unlikely to cause symptomatic influenza.7
Severely immunocompromised individuals should not administer FluMist Quadrivalent. However, other persons at higher risk for influenza complications—including pregnant women, persons with asthma, and persons aged 50 years or older—can administer FluMist Quadrivalent.7
FluMist Quadrivalent requires active inhalation (i.e., sniffing) by the patient for proper administration.
FluMist Quadrivalent recipients can breathe normally during administration. Sniffing is NOT necessary.7
All patients with asthma are not eligible to receive FluMist Quadrivalent.
Children younger than 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.1
FluMist Quadrivalent is just for children.
FluMist Quadrivalent is indicated for eligible individuals ages 2 through 49. FluMist Quadrivalent is similar to FluMist except that FluMist Quadrivalent helps to provide protection against an additional flu strain. The same people who were eligible for FluMist are eligible for FluMist Quadrivalent.1 In a post-hoc analysis conducted in 3,637 adults 18-49 years of age (FluMist, n=2,411; placebo, n=1,226) during the 1997-1998 influenza season, FluMist was effective in reducing cases of influenza-like illness (ILI) vs. placebo. However, the primary analysis conducted in all adults aged 18-64 years did not find FluMist was effective against all ILIs but only against severe episodes.8 With FluMist Quadrivalent, the most common adverse reactions were runny nose or nasal congestion in recipients of all ages and sore throat in adults.1
If a patient sneezes or blows their nose after receiving FluMist Quadrivalent, they need to be re-vaccinated.
Dripping down the throat, sneezing, or swallowing may occur after vaccination. Re-vaccination is not necessary.7
FluMist Quadrivalent cannot be given to any patient if he or she is ill.
FluMist Quadrivalent can be given to people with minor illnesses (e.g., diarrhea or mild upper respiratory tract infection with or without fever). However, if severe nasal congestion is present that might limit delivery of the vaccine to the nasal lining, then delaying of vaccination until the nasal congestion is reduced should be considered.9
FluMist®Quadrivalent is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, 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.
FluMist®Quadrivalent (Influenza Vaccine Live, Intranasal) 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.
Please see full Prescribing Information for FluMist®Quadrivalent, including Patient Information.