Four months ago, the FDA would not even read Moderna's new flu shot. On Thursday, an FDA panel backed that same shot in a 9-0 vote.
Nothing about the shot changed. But the answer sure did.
The shot is called mFlusiva. It runs on mRNA, the tech behind Moderna's COVID shot.
In plain terms, mRNA teaches your cells how to fight a virus. That also makes the shot quick to build.
The panel voted 9-0 that it helps more than it hurts. That vote covered adults aged 50 to 64.
Members also backed it for those 65 and up. The FDA should make its final call by August 5.
It usually agrees with its own panel. But it does not have to.
Here is the twist. Back in February, the FDA's top vaccine boss would not even read the file.
He wanted the shot tested against the high-dose shot seniors get. Moderna had used a regular one instead.
Moderna pushed back in public. The agency took the file just days later.
Both leaders behind that strict line have since left. A drugmaker does not often win a fight like that.
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The whole pitch for mRNA is speed. These shots are faster to make than older ones.
So Moderna can brew new doses fast when the virus shifts. Think of it like updating an app overnight.
You do not wait a year for a new phone. That speed is the real selling point.
The early data backed it up. Moderna tested about 40,000 people age 50 and up.
The shot cut flu cases by about 27%. That was next to a standard flu shot.
The flu hits older adults the hardest. Tens of thousands die from it in a bad year.
A shot that works better could save many of them. For Moderna, this biotech is chasing life after COVID.
It would help fill out a thin lineup beyond its COVID shot.
The panel did raise a few worries. The trial ran for a short time.
It also logged few cases of one flu strain. Even so, Wall Street saw the FDA's own notes as a good sign.
They found no big problems. The side effects looked normal for an mRNA shot.
People had a sore arm, fever, and aches. Those showed up a bit more than with today's shots.
The August 5 decision is the next marker. A big follow-up study of up to 800,000 seniors comes after that.
Moderna also has to win over a public that is split on mRNA. The panel said yes, and now the clock runs to August 5.
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