The Food and Drug Administration approved the 2016-2017 FluMist Quadrivalent vaccine on July 1, 2016 for use during the upcoming influenza season. In addition, they have approved FluMist Quadrivalent lots for release and distribution. In its statement, the FDA noted that the benefits of FluMist Quadrivalent outweigh any potential risks. More information can be found on the FDA website: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm508761.htm
AstraZeneca has decided to make a limited amount of FluMist Quadrivalent available for use in the US by licensed healthcare providers. We have ensured that any US healthcare provider will be informed of the ACIP recommendation if they request FluMist Quadrivalent. Consistent with the FDA statement, AstraZeneca continues to believe FluMist Quadrivalent is a safe and effective option for vaccinating eligible people against seasonal influenza throughout the entire season. The vaccine is being distributed as usual outside the US. We respect the ACIP recommendations for the 2016-2017 season for the United States.
ACIP recommendation was based on vaccine effectiveness data showing low effectiveness of FluMist Quadrivalent against influenza A(H1N1)pdm09 in the United States and other countries, which demonstrated moderate effectiveness with FluMist Quadrivalent. More information on these observational studies can be found in the FAQ section.
AstraZeneca places the highest priority on patient health, medical need, and the impact our products may have on overall public health. We know that many people have relied on FluMist and FluMist Quadrivalent to protect themselves and their families since 2003. We are pursuing a broad-based scientific investigation into the causes of the reduced effectiveness of FluMist Quadrivalent observed in recent seasons, with the goal of enhancing the effectiveness of the 2017-2018 formulation.
ACIP recommendation was based on vaccine effectiveness data showing low effectiveness of FluMist Quadrivalent against influenza A(H1N1)pdm09 in the United States. More information on these observational studies can be found in the FAQ section.
The Food and Drug Administration (FDA) has approved FluMist Quadrivalent influenza vaccine for the 2016-2017 season. More information can be found on the FDA website: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm293952.htm
Information on the FDA website describes the benefits and risks of FluMist Quadrivalent: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm508761.htm
If you have identified a need for FluMist Quadrivalent despite the ACIP recommendation that it should not be used, talk to your FluMist Quadrivalent distributor regarding availability.
The ACIP develops recommendations on how to use vaccines to control disease in the United States. The recommendations include the age(s) when the vaccines should be given, the number of doses needed, the amount of time between doses, and precautions and contraindications.
The Committee's recommendations are forwarded to CDC’s Director for approval. Once the ACIP recommendations have been reviewed and approved by the CDC Director and the U.S. Department of Health and Human Services, they are published in CDC’s Morbidity and Mortality Weekly Report (MMWR). The MMWR publication represents the final and official CDC recommendations for immunization of the U.S. population.
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.