Moderna's mRNA flu shot earns FDA approval after rollercoaster review
Moderna's new flu vaccine, mFLUSIVA, is approved for all adults ages 50 and up.
On Thursday, the Food and Drug Administration (FDA) granted approval to Moderna's mRNA flu vaccine, marking the first time the agency has sanctioned such a vaccine. The vaccine, named mFLUSIVA, is designed for adults aged 50 and older. The FDA's decision came after unanimous approval from its advisors in June, which was based on the vaccine's higher efficacy and a solid safety record, demonstrated in trials involving nearly 44,000 participants.
The FDA had set an initial deadline of August 5 for making a final decision on the vaccine's approval. Despite the initial wave of support from the FDA advisors, the path to approval was far from straightforward. Health Secretary Robert F. Kennedy Jr., a staunch anti-vaccine advocate, had initiated a campaign to discourage flu shots during a severe flu season.
His actions, which included canceling the federal campaign to promote flu vaccinations, despite the CDC's funding and the CDC's warning about the high number of child deaths, added a layer of controversy to the vaccine's journey towards approval.
Written by urgent.news from Ars Technica's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
This story
This is one outlet's version. Read the fullest account.
