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FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration

This marks the first influenza vaccine that does not need to be administered by a healthcare provider.

FluMist is the first vaccine to prevent influenza that does not need to be administered by a healthcare provider.
FluMist is the first vaccine to prevent influenza that does not need to be administered by a healthcare provider.

Key takeaways:

·     FluMist is the first vaccine to prevent influenza that does not need to be administered by a healthcare provider.

·      FluMist contains a weakened form of live influenza virus strains and is sprayed in the nose. A prescription is still required.

·      Vaccine recipients will be sent the vaccine, the prescribing information, information for patients and their caregivers ,and instructions for use.

 

Last week, the U.S. Food and Drug Administration approved FluMist for self- or caregiver-administration. FluMist is approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. FluMist is sprayed into the nose and has been used safely and effectively for many years. It was initially approved by the FDA in 2003 for use in individuals 5 through 49 years of age, and in 2007, the FDA approved the use of FluMist to include children 2 through 5 years of age. It is the first vaccine to prevent influenza, more commonly known as the flu, that does not need to be administered by a health care provider. 

“Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”

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