Parents can now give their children ages 2 and up — at home — a nasal flu vaccine that the U.S. Food and Drug Administration (FDA) withdrew in 2016 because it was ineffective, and which has been associated with reports of children’s deaths, according to the Vaccine Adverse Event Reporting System (VAERS).
AstraZeneca’s FluMist vaccine won FDA approval late last week for at-home administration, making it the first “take-out” flu vaccine that doesn’t need to be administered by a healthcare provider.
According to MedPageToday, the FDA approved FluMist for self- or caregiver-administration, for people ages 2-49, with a doctor’s prescription. A usability study determined people ages 18 and over could either self-administer the vaccine or administer it to eligible people using the instructions provided.
The vaccine, which is sprayed into the nose, targets influenza virus subtypes A and B, MedPageToday said.
FluMist was first approved in 2003 but previously was allowed to be administered only in medical and pharmacy settings.
In a statement, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said FluMist “provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families.” […]
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