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FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) Vaccine Now Available in the US for Annual Flu Season

By: via Business Wire

Needle-free vaccine option can help reduce influenza infections

The Centers for Disease Control and Prevention (CDC) recommends influenza vaccines as the primary protection against the flu virus to reduce the burden on the US healthcare system

AstraZeneca today announced that FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) doses are now available in the US for the 2021-2022 influenza season. FLUMIST QUADRIVALENT, the only Food and Drug Administration (FDA)-approved nasal-spray flu vaccine, is indicated for people ages 2 through 49. The bulk of AstraZeneca’s supply for the 2021-2022 flu season is expected to be available by mid-September.

In line with the 2021-2022 recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP), FLUMIST QUADRIVALENT continues to be an option for flu vaccination in the US this season. Vaccines may not prevent influenza in everyone who gets vaccinated.

The CDC continues to stress the importance of receiving a yearly flu vaccine, citing vaccination as the most effective protection against seasonal flu infection. Additionally, they reinforce that flu vaccination during the 2021-2022 season will help protect the public against preventable illness, as well as help alleviate burden on the healthcare system.

“As the world continues to navigate an unpredictable public health landscape with coinciding flu and COVID-19 viruses, AstraZeneca remains committed to following the science and putting people and their communities first by helping ensure families have access to a needle-free vaccination option,” said Mina Makar, Senior Vice President, US Respiratory & Immunology at AstraZeneca. “Improving patient and public health is at the heart of what we do, and we are proud to be doing our part in fighting the flu again this season by working with our partners to provide FLUMIST QUADRIVALENT to those eligible this year.”

Since FLUMIST QUADRIVALENT is the only FDA-approved flu vaccine to use a needle-free nasal spray administrative technique, it may be preferred by eligible patients. AstraZeneca’s live attenuated influenza vaccine (LAIV) (either as trivalent or quadrivalent formulations) has been approved by the FDA since 2003 and is covered by most health insurance plans. The most common side effects of FLUMIST QUADRIVALENT are runny or stuffy nose, sore throat, and fever over 100°F.

Please note, all available influenza vaccines are manufactured differently and different preparations have different indications as licensed by the FDA. Those interested in receiving a flu vaccine are encouraged to speak with a healthcare provider to determine if FLUMIST QUADRIVALENT is right for them and can use an online vaccine locator tool to find where it is available in their local area.

IMPORTANT SAFETY INFORMATION

  • FLUMIST QUADRIVALENT is contraindicated in persons who have had a severe allergic reaction (eg, 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
  • 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
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine
  • 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 were runny nose or nasal congestion in 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

INDICATION

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.

Please see full Prescribing Information for FLUMIST QUADRIVALENT, including Patient Information.

About the Public Health England 2020-2021 Flu Vaccine Effectiveness Results

Public Health England (PHE) has published end-of-season influenza surveillance for the 2020-2021 season in the UK. Due to low levels of circulating influenza during the 2020-2021 season, certain aspects of vaccine effectiveness surveillance were not possible, including virus characterization and vaccine effectiveness estimates.

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.

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