US FDA approves AstraZeneca's self-administered nasal spray flu vaccine
Reworks lede, adds details on availability in paragraphs 4, details on the vaccine in paragraph 5, other vaccines in paragraph 9
Sept 20 (Reuters) -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.
AstraZeneca plans to make the vaccine available through a third-party online pharmacy. Customers will have to complete a screening and eligibility assessment when they order FluMist.
The approval 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, director of the FDA's Center for Biologics Evaluation and Research.
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.
The FDA said individuals between two and 17 years old should not self-administer FluMist, they should get it from a caregiver instead.
GSK GSK.L, Sanofi SASY.PA and CSL CSL.AX, among others, also make flu vaccines.
Reporting by Puyaan Singh in Bengaluru; Editing by Shailesh Kuber, Tasim Zahid and Alan Barona
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