US FDA approves first self-administered nasal flu vaccine

The U.S. Food and Drug Administration said on Friday it has approved AstraZeneca's (AZN.L), nasal spray flu vaccine for self-administration, making it the first of its kind.

FluMist is the first vaccine to prevent influenza that does not need to be administered by a healthcare provider, the regulator said.

The flu is a common and contagious respiratory disease caused by influenza viruses that typically circulates in the U.S. during the fall and winter.

The vaccine, which was first approved in 2003 to be administered only by healthcare providers, contains a weakened form of live influenza virus strains and is sprayed in the nose.

According to the U.S. Centers for Disease Control and Prevention, the flu has resulted in approximately 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations, and 4,900 to 51,000 deaths annually between 2010 and 2023.

In a press release, the FDA stated that a prescription was still required to receive FluMist.

"The most commonly reported side effects of FluMist are fever over 100°F in children 2 through 6 years of age, runny nose and nasal congestion in individuals 2 through 49 years of age and a sore throat in adults 18 through 49 years of age," it added.

The FDA further maintained that the vaccine manufacturer plans to make the vaccine available through a third-party online pharmacy.

"Those who choose this option will complete a screening and eligibility assessment when they order FluMist. The third-party pharmacy determines eligibility based on the completed screening and, if it is determined that the intended vaccine recipient is eligible, the pharmacy writes the prescription and ships the vaccine to the address provided by the individual who placed the order," the drug regulatory authority stated.