FDA Approves First Self-Administered Nasal Spray Flu Vaccine

The FDA approved FluMist (AstraZeneca) on Friday for self-administration by adult patients up to 49 years or caregiver administration for those aged 2 to 17 years to help prevent influenza virus subtypes A and B.¹

This approval makes FluMist the only self-administered flu vaccine; it contains a weakened form of live influenza virus strains and is sprayed in the nose. FluMist was originally approved in 2003 for patients aged 5 to 49 years. In 2007, the approval was extended to children aged 2 to 5 years. This latest approval allows patients to choose between receiving the vaccine from a health care provider, administering it themselves, or having 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 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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

For this approval, the FDA required human factors/usability studies to determine if patients aged 18 to 49 years could appropriately administer FluMist.² The results showed that 100% of intended users administered a full dose. Also, similar efficacy, immunogenicity, and adverse events were observed with self-administration as with administration by a health care provider.

The FDA noted that those interested in self- or caregiver administration still need a prescription¹; AstraZeneca plans to makeFluMist available through a third-party online pharmacy. Therefore, those interested must complete a screening and eligibility assessment when ordering the vaccine.

If the pharmacy determines the intended recipient is eligible, it will write the prescription and ship the vaccine to the provided address. Then, the vaccine can be administered to the prescribed household member at their convenience, either individually or by a caregiver depending on the recipient’s age.

Commonly reported FluMist adverse effects include a fever over 100°F in children aged 2 to 6 years, a sore throat in adults aged 18 to 49 years, and runny nose and nasal congestion in those aged 2 to 49 years. However, the flu also can cause mild to severe illness with various symptoms that include body aches, coughing, fever, tiredness, sore throat, and/or a stuffy or runny nose. According to CDC data, influenza resulted in 9.3 million to 41 million illnesses; 100,000 to 710,000 hospitalizations; and 4900 to 51,000 deaths annually from 2010 to 2023.

Therefore, immunization is considered the safest and easiest way to prevent flu infection and serious illness. Despite this, as of January 6, 2024, only about 47% of adults and children received a flu vaccine.³

Among adults, coverage increased by age, with the highest coverage being in those aged 75 and older (80%) and the lowest coverage in those aged 18 to 29 (32%). Conversely, coverage declined with age in children, with the highest coverage being among those aged 6 to 23 months (60%) and the lowest coverage being among those aged 12 to 17 years (41%).

“Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the US population every year and may result in serious complications, including hospitalization and death,” Marks said in a press release.¹ “This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing 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-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration

2. FluMist approved for self-administration in the 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. Flu 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