The Food and Drug Administration announced Friday it had broadened the approval of the FluMist nasal spray to become the first “self-administered” influenza vaccine — though a delay in the change means the vaccine will not be available to ship to homes until next year’s flu season at the earliest.
“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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The FluMist vaccine, manufactured by AstraZeneca, had previously been approved back in 2003 to be given by health care providers similar to other flu shots.
The FDA says patients will still need to get a prescription for the vaccine from a health care provider.
“We’re working diligently to bring this ‘first-of-its-kind’ innovative and convenient self-administrated flu vaccine to consumers and look forward to launching FluMist Home as soon as next flu season,” a spokesperson for the company said in a statement.
Though a delay in the change means the vaccine won’t be available to ship to homes until the earliest flu season of the following year, the Food and Drug Administration announced on Friday that it had expanded the approval of the FluMist nasal spray, making it the first “self-administered” influenza vaccine.
Director of the FDA’s Center for Biologics Evaluation and Research Dr. Peter Marks said in a statement, “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.”.
AstraZeneca’s FluMist vaccine was first authorized for administration by healthcare professionals in 2003, much like other flu shots. The vaccine manufacturer can now sell FluMist to adults to use on themselves or their children at home.
According to the FDA, individuals will still require a doctor’s prescription in order to receive the vaccination.
An online pharmacy will be used by AstraZeneca to directly sell FluMist to patients. Adults will be able to order shipments to their homes after completing a screening questionnaire to obtain the prescription.
Additionally, FluMist’s recommended user base is restricted in certain ways. Certain patients should not receive this vaccine because it uses a live but weakened strain of the virus, such as those who are pregnant or seriously immunocompromised.
Because of its “poor or relatively lower effectiveness” in comparison to other vaccines, the Centers for Disease Control and Prevention recommended against using FluMist in 2016. As a result, pharmacies and physicians no longer use it as frequently.
Subsequently, AstraZeneca changed the vaccine’s antigens, regaining the CDC’s recommendation as of 2018.
According to the CDC, “due to limited use” in the United States, it has not had enough data since then to update official effectiveness estimates comparing FluMist to other flu vaccines. s.
However, compared to more commonly used shots, AstraZeneca’s data indicates that the shot’s effectiveness in Europe has been “comparable.”.
After AstraZeneca submitted data last year demonstrating that adults could correctly follow instructions to administer the vaccine spray on their own, the company had initially told investors it hoped the FDA would broaden approval in time for this flu season.
When asked why the FDA’s approval decision arrived later than AstraZeneca had previously stated, the company remained silent.
According to a company statement, “We’re working tirelessly to bring this ‘first-of-its-kind’ innovative and convenient self-administrated flu vaccine to consumers and look forward to launching FluMist Home as soon as next flu season.”.
In order to “ensure a seamless customer experience” for FluMist’s home use launch, the spokesperson stated that AstraZeneca needed more time to collaborate with its partners.