FDA Approves First Self-Administered Flu Vaccine, FluMist, for Home Use

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The U.S. Food and Drug Administration (FDA) made a significant move on Friday by approving the first-ever flu vaccine that can be self-administered, although it won’t be available for the current respiratory virus season.

The vaccine, FluMist, is a nasal spray developed by AstraZeneca and has been a familiar name in flu protection since 2003. Until now, it required a prescription and administration by a healthcare professional, but this new approval opens the door for self-administration, allowing adults and caregivers to administer it to children at home.

AstraZeneca plans to distribute this self-administered vaccine through a third-party online pharmacy, which will prescribe and deliver it after assessing the patient’s eligibility. The company expects this option to roll out in time for the next respiratory virus season.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of this development, stating, “Today’s approval provides a new option for receiving a safe and effective seasonal influenza vaccine, enhancing convenience and accessibility for families.” He reiterated that annual vaccination remains the most effective method to combat influenza, which can lead to serious health complications.

The flu is not a trivial concern, causing an estimated 35 million illnesses, 400,000 hospitalizations, and 25,000 deaths during the 2023-24 season, according to the U.S. Centers for Disease Control and Prevention (CDC). Despite this, vaccination rates have declined in recent years, with only about half of adults and children receiving their annual shots last season.

FluMist stands out as the sole needle-free flu vaccination option in the U.S., employing a live, weakened form of the influenza virus, unlike injectable vaccines that use killed viruses or proteins. AstraZeneca asserts that FluMist’s effectiveness is on par with traditional flu vaccines.

When the FDA announced its intention to explore self-administration, many healthcare professionals welcomed the initiative, but some expressed skepticism about its potential impact on vaccination rates. Dr. Ashish Jha, dean of the Brown University School of Public Health, noted that while self-administration could enhance accessibility, merely increasing options may not significantly boost vaccination rates. He highlighted that many people experience needle phobia, and providing more needle-free options could encourage them to get vaccinated. He remains optimistic, suggesting that enhanced marketing and awareness might lead to better public engagement regarding the vaccine.

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