The pharmaceutical large expressed optimism that its new flu shot could be obtainable this 12 months, after approval considerations.
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By Reuters and The Related Press
Revealed On 18 Feb 2026
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The federal company tasked with regulating medication in the USA has mentioned it can evaluate a flu vaccine software from the pharmaceutical large Moderna, one week after it declined to take action in an uncommon transfer.
Moderna introduced on Wednesday that the Meals and Drug Administration (FDA) had accepted a revised software searching for full approval for a brand new flu shot to be provided to sufferers between the ages of fifty and 64 and expedited approval for these over 65.
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“Pending FDA approval, we stay up for making our flu vaccine obtainable later this 12 months in order that America’s seniors have entry to a brand new possibility to guard themselves towards flu,” CEO Stephane Bancel mentioned in an announcement.
He additionally expressed thanks for the FDA’s “engagement” on the difficulty.
The FDA’s choice to simply accept Moderna’s software marked an abrupt reversal from its earlier stance. On February 10, Moderna revealed that the FDA had denied its software to evaluate the brand new flu vaccine to be used amongst older adults.
That announcement sparked considerations within the pharmaceutical trade about how new vaccines could be obtained underneath US President Donald Trump, whose administration has rescinded sure vaccine pointers.
Some Trump officers, most notably Well being and Human Companies Secretary Robert F Kennedy Jr, have additionally unfold false claims about vaccine security.
On the time, Moderna referred to as the company’s rejection “inconsistent with earlier written communications” with the FDA.
The choice, Bancel mentioned in an announcement, “didn’t establish any security or efficacy considerations with our product” and “doesn’t additional our shared objective of enhancing America’s management in growing revolutionary medicines”.
The company’s refusal to think about the corporate’s software was an uncommon transfer.
In a “refusal to file” letter rejecting the preliminary software, the FDA’s vaccine director Vinay Prasad argued that Moderna ought to have included a high-dose model for comparability in its trial course of.
Moderna had undertaken a 40,000-person medical trial, targeted on adults age 50 and older, that concluded its new vaccine was more practical than a typical shot.
The corporate publicly responded that the FDA had itself advisable that strategy when it accredited the trial research.
In a compromise, Moderna agreed to conduct one other research as soon as the brand new flu shot is offered. The FDA is aiming to achieve a choice on the revised software by August 5.
The flu shot was created with mRNA know-how, a topic of frequent criticism from Kennedy, who has promoted anti-vaccine views and changed consultants within the Well being and Human Companies Division with figures who share his scepticism.
Final June, Kennedy cancelled almost $500m in federal analysis grants and contracts for analysis into mRNA vaccines.
