Americans can now vaccinate themselves against the flu without the assistance of a healthcare worker.
For the first time, the FDA approved a vaccine that people can administer themselves, clearing the use of AstraZeneca’s FluMist for people 2 to 49 years of age. The vaccine had already snagged general use approval for those populations, but had to be administered by a healthcare professional.
Friday’s approval was based on a usability study from the large UK pharma, showing that people 18 or older could self-administer the vaccine or give it to someone else within the qualifying age range. Consumers will be able to get the product delivered through a third-party online pharmacy.
The vaccine is administered with a nasal sprayer, with a full dose divided in half so that patients can give themselves a portion in each nostril.
“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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Former FDA Commissioner Scott Gottlieb applauded the agency and company for the regulatory nod.
“This is in keeping with a broader, longstanding effort by FDA to expand consumer access to medicines and will help reduce costs and barriers to care,” he wrote on X, formerly known as Twitter.
It’s the second major approval for a nasal spray in as many months, after the FDA approved neffy as a treatment for anaphylaxis in August. That decision marked the first time that the FDA approved a non-injectable epinephrine product.