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Moderna's mRNA flu shot earns FDA approval after rollercoaster review

Despite significant drama from Trump officials this year, the Food and Drug Administration has for the first time approved a flu vaccine that uses mRNA technology.

On Thursday, vaccine maker Moderna announced that its flu shot, mRNA-1010, aka mFLUSIVA, had earned approval for use in all adults ages 50 and up. The approval announcement follows a unanimous vote by FDA advisors in June to approve the vaccine. That vote was based on its superior efficacy to existing seasonal flu shots and a good safety record demonstrated in trials that included nearly 44,000 people. After that vote, the FDA set a goal of August 5 for a decision on the vaccine's fate.

While the unanimous support from FDA advisors boded well for Moderna's shot, the overall path to approval was treacherous and uncertain, even until the end. For one thing, current Health Secretary Robert F. Kennedy Jr. is a well-established anti-vaccine advocate who has worked diligently in his time in office to thwart vaccinations. One of his first acts as health secretary was canceling a federal campaign to encourage people to get flu shots in the midst of a bad flu seasonโ€”despite the fact that the Centers for Disease Control and Prevention had already paid for the campaign and the flu season was killing relatively high numbers of children.

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Schwartz confirmed as CDC director after bungling confirmation hearing

In a 51โ€“44 vote Wednesday, the US Senate confirmed Erica Schwartz as director of the Centers for Disease Control and Prevention, despite failing miserably to convince senators last month that she could stand up to anti-vaccine Health Secretary Robert F. Kennedy Jr.

The confirmation ends a nearly yearlong vacancy for the position since Kennedy fired the previous CDC director, Susan Monarez, last August. Monarez was ousted after she refused to rubber-stamp vaccine recommendations from a panel of Kennedy's hand-selected advisors, who hold similar anti-vaccine views to his own.

Schwartz is highly qualified for the role, coming to the CDC with a medical degree, a masterโ€™s degree in public health, and a law degree. She previously had a long stint as a Navy officer and held leadership roles including chief medical officer for the US Coast Guard and deputy surgeon general in the first Trump administration. Notably, she has been a public advocate for vaccines and outbreak preparedness.

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ยฉ Wikipedia | HHS

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