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The FDA for self- or caregiver-administration, making it the first influenza vaccine that does not need to be administered by a healthcare provider, the agency announced on Friday.

The nasal spray, which contains weakened forms of live virus strains, requires a prescription and is approved for the prevention of flu caused by influenza virus subtypes A and B in individuals ages 2 to 49 years.

"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. "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."

Approval was supported by a usability study confirming that individuals 18 years and older could either self-administer the vaccine or administer it to eligible individuals when given instructions for use or without any additional guidance.

"For the first time, families and caregivers will be able to protect themselves against influenza with a needle-free, self-administered vaccine, from the convenience of their own home," said Ravi Jhaveri, MD, of the Northwestern University School of Medicine in Chicago, from drugmaker AstraZeneca. "Each year, influenza poses a significant burden for people, society, and health systems; additional tools to increase access to vaccinations, while also reducing disparities, are critical."

The most commonly reported adverse events with FluMist are fever over 100°F in children ages 2 to 6 years, runny nose and nasal congestion in individuals ages 2 to 49 years, and a sore throat in adults ages 18 to 49.

With the approval, the nasal spray can now either be administered by a provider in a healthcare setting (including a pharmacy), self-administered by an adult vaccine recipient, or administered to children by an adult caregiver.

AstraZeneca said it plans to make the vaccine available through an online pharmacy for those interested in self- or caregiver-administration. According to the FDA, individuals will need to complete a screening and eligibility assessment when they order the vaccine, and if the pharmacy determines eligibility, the pharmacy will write a prescription and ship the vaccine to the address provided by the individual.

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