FDA approves first self-administered nasal spray flu vaccine

The FDA Approved FluMist (AstraZeneca) will be self-administered by adult patients up to 49 years old, or administered by caregivers for children between 2 and 17 years old, on Friday to help prevent infection with influenza types A and B.¹

This approval makes FluMist the only self-administered influenza vaccine. The vaccine contains a weakened, live influenza virus strain that is sprayed into the nose. FluMist was originally approved in 2003 for patients ages 5 to 49. In 2007, approval was expanded to children ages 2 to 5. With this latest approval, patients can choose to receive the vaccine from a healthcare professional, administer it themselves, or have a caregiver aged 18 or older administer it.

The FDA has approved FluMist (AstraZeneca) for self- or caregiver administration, making it the first self-administered flu vaccine option. | Image credit: Olivier Le Moal – stock.adobe.com

“Today's approval of the first influenza vaccine for self- or caregiver administration provides individuals and families with a new option for receiving a safe and effective seasonal influenza vaccine that is more convenient, flexible and accessible,” said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research. In a press release.

Regarding this approval, the FDA Required A human factors/usability study to determine whether patients aged 18 to 49 years can administer FluMist appropriately.² Results showed that 100% of subjects administered the full dose, and self-administration was associated with similar efficacy, immunogenicity, and adverse events as administration by a healthcare professional.

The FDA noted that people interested in self-administering or caregiver-administering the drug will still need a prescription.¹AstraZeneca plans to make FluMist available through third-party online pharmacies, so those interested will need to complete a screening and eligibility assessment when ordering the vaccine.

If the pharmacy determines that the individual is eligible for the vaccine, they will write a prescription and ship the vaccine to the designated address. The vaccine will then be administered at the convenience of the prescribed household member, either individually or by a caregiver, depending on the individual's age.

Commonly reported side effects of FluMist include fever over 100°F in children 2-6 years old, sore throat in adults 18-49 years old, and runny or stuffy nose in adults 2-49 years old. However, influenza can also cause mild to severe illness with a range of symptoms, including body aches, cough, fever, fatigue, sore throat, and stuffy or runny nose. According to CDC data, from 2010 to 2023, influenza caused 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths annually.

Therefore, vaccination is considered the safest and easiest way to prevent influenza infection and serious illness. Despite this, as of January 6, 2024, only about 47% of adults and children have been vaccinated. Received Influenza vaccine.³

For adults, the insurance enrollment rate increases with age, with the highest rate for those aged 75 and over (80%) and the lowest for those aged 18 to 29 (32%). Conversely, for children, the insurance enrollment rate decreases with age, with the highest rate for those aged 6 to 23 months (60%) and the lowest for those aged 12 to 17 (41%).

“Getting vaccinated annually is the best way to prevent influenza, which causes illness in a significant percentage of Americans each year and can lead to serious complications, including hospitalization and death,” Marks said in a press release.¹ “This approval provides an additional influenza vaccination option and demonstrates the FDA's commitment to improving the public health.”

References

1. FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver Administration. FDA. News Release. September 20, 2024. Accessed September 23, 2024. https://www.fda.gov/news-events/press-payments/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration

2. FluMist approved for self-administration in US. AstraZeneca. News release. September 20, 2024. Accessed September 23, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html

3. Influenza Vaccination Coverage Update. CDC. January 19, 2024. Accessed September 23, 2024. https://www.cdc.gov/flu/spotlights/2023-2024/vaccination-coverage-update.htm#:~:text=In%202020%2D2021%2C%20an%20estimated,and%20older%20to%20be %2070%25