US FDA Approves AstraZeneca's sBLA for Self-administration

The US Food and Drug Administration (FDA) has accepted AstraZeneca's Supplemental Biologics License Application (sBLA) to review and consider approving the self- or caregiver-administered option for FluMist Quadrivalent, a nasal spray that does not require a needle. In the event of approval, FluMist will become the inaugural flu vaccine that eligible patients can self-administer or have caregivers administer, providing an extra choice for influenza vaccination.

The usability study on the sBLA has provided support for the fact that individuals above 18 years old are capable of independently administering FluMist to eligible patients aged 2-49 years. This is feasible when they are provided with instructions for use and do not require any further assistance. FluMist, when administered via nasal spray, has ample data indicating its effectiveness and safety, which is comparable to other flu vaccines, as per pharmabiz. It is anticipated that the Prescription Drug User Fee Act (PDUFA) date, which represents the FDA's regulatory decision date, will occur within the first quarter of 2024. FluMist is expected to be accessible for self-administration in the US during the 2024/2025 flu season, if it gets approved at that time. Ravi Jhaveri, MD, serves as the division head of infectious disease at Virginia H.

According to the Rogers Professor in Infectious Diseases and Professor of Pediatrics (Infectious Diseases) at Northwestern University School of Medicine in Chicago, USA, offering a self-administered alternative for FluMist Quadrivalent would capitalize on the product's distinctive features and grant individuals and families a convenient new option to safeguard their loved ones from the flu. The 2022-2023 flu season witnessed a decrease in vaccination rates among children and adults below the age of 50, emphasizing the urgent requirement for more accessible solutions. The option of choosing the location for receiving a needle-less flu vaccine could potentially enhance accessibility and raise vaccination rates. This would be particularly advantageous for individuals and parents greatly affected by this hazardous and easily transmitted respiratory illness.