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mRNA cancer vaccine succeeded in Phase 3 melanoma trial, Moderna and Merck say

Pharmaceutical partners Moderna and Merck announced on Wednesday that their novel mRNA-based vaccine—individually tailored to target a patient's unique cancer mutations—was effective in a late-stage clinical trial of patients with melanoma, one of the deadliest forms of skin cancer.

The announcement was scant on details, but if the success holds, it stands to realize the high aspirations for both mRNA vaccines and individualized cancer-targeting medicines in cancer therapy, providing a first success for both treatment types.

The Phase 3 trial included 1,137 patients who had stage IIB–IV melanoma that had been surgically removed prior to their treatment in the trial. Patients were randomized 2-1 to receive either a combination treatment of the tailored mRNA vaccine (intismeran or mRNA-4157) with Merck's established monoclonal antibody cancer treatment Keytruda, or they received treatment with Keytruda alone. Both patient groups were treated for about a year. The trial was placebo-controlled and double-blind, meaning neither the doctors nor the patients knew which treatment patients were randomly assigned to receive.

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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 season—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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