On Tuesday, the US Food and Drug Administration (FDA) announced that it has accepted AstraZeneca’s application seeking approval to sell a new nasal flu vaccine which will allow patients and caregivers to administer the vaccine themselves at home, and the agency is in the process of reviewing it.
The vaccine, which will be sold under the name FluMist Quadrivalent, would become the first self-administered vaccine for the flu. It would not be required to be administered by a healthcare practitioner, if it is approved.
The FDA had already approved FluMist for use by healthcare professionals in 2003.
AstraZeneca says it expects the FDA will make its decision on the vaccine by the first quarter of 2024, adding that if approved it would expect the vaccine would be released to the public for self-administration in the United States in time to be administered during the 2024-2025 flu season.
AstraZeneca said the supplemental application it submitted presented data from a usability study which confirmed that persons over 18 years old were capable of self-administering or administering doses of FluMist to eligible patients between 2 and 49 years of age, if given the instructions for the vaccine’s administration, and no additional guidance.