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FDA Approves Moderna's mRNA-Based Flu Vaccine for Adults Aged 50 and Older

Moderna has secured US regulatory approval for its first mRNA-based influenza vaccine, mFLUSIVA, for adults aged 50 and older.

By Staff Correspondent
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Moderna announced on Wednesday that the US Food and Drug Administration (FDA) has approved its new influenza vaccine, mFLUSIVA, for use in adults aged 50 and older. This marks the first mRNA-based flu vaccine to receive approval in the United States. The vaccine is expected to be available for eligible populations during the 2026-2027 respiratory virus season.

What is mRNA technology?

Messenger RNA (mRNA) technology involves using a synthetic copy of a naturally occurring genetic material to instruct cells to produce a protein that triggers an immune response. This technology was notably used to develop vaccines against COVID-19, which are considered safe and effective by global health authorities.

Why was there a delay in the approval process?

In February, the FDA initially rejected Moderna's application for review, citing inadequate clinical trial data. However, after a follow-up meeting, the agency reversed its decision, allowing the approval to proceed.

Who criticized this technology, and why?

Robert F. Kennedy Jr., a vocal vaccine skeptic, has criticized mRNA technology, which has led to a cut in federal research grants for mRNA development. Despite this criticism, mRNA technology has been lauded for its role in the rapid development of COVID-19 vaccines.

What does this mean for the upcoming flu season?

With the FDA's approval, Moderna's mFLUSIVA is set to be available for eligible populations, offering an additional option for flu prevention during the 2026-2027 flu season.

Source: BSS

FAQ

When will mFLUSIVA be available for the public?
Moderna expects to have mFLUSIVA available for eligible populations in the US for the 2026-2027 respiratory virus season.
What was the initial reason for the FDA's rejection of Moderna's application?
The FDA initially rejected the application in February, citing inadequate clinical trial data.
Who has criticized mRNA technology?
Robert F. Kennedy Jr. has criticized mRNA technology, leading to cuts in federal research grants.
What was the FDA's role in the approval process?
The FDA reversed its initial decision after a follow-up meeting with Moderna, leading to the approval of mFLUSIVA.

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