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FDA approves Moderna’s flu shot in first for mRNA vaccines
['Millie Hoe', 'Reporter', 'Bioprocess Insider']
bioxconomy
Last week, pharmaceutical company Moderna announced that the US Food and Drug Administration (FDA) approved its mRNA vaccine against seasonal influenza (mRNA-1010 or mFLUSIVA).
This is the first vaccine of its kind to be approved for protection against flu and is Moderna’s fourth FDA-approved product.
Related:FDA flip-flop: Moderna’s flu vaccine gets second shot after initial snubFinding parityThe FDA’s decision was prompted by positive results from Moderna’s Phase III clinical trials (NCT05827978 and NCT06602024), which showed a favorable safety profile and consistent vaccine efficacy compared with the treatment standard.
A head-to-head between the mRNA-1010 and the “standard” flu shot showed that Moderna’s vaccine is 26.6% more effective.
Related:MHRA unleashes guidance on mRNA immunotherapiesModerna’s mRNA flu vaccine initially hit a stumbling block earlier this year following the FDA issuing a Refusal to File letter signed by Center for Biologics Evaluation and Research (CBER) head Vinay Prasad in February.