The FDA approved Moderna’s flu vaccine mFLUSIVA, a regulatory decision that comes six months after the agency refused to review the mRNA shot and then quickly reversed its position. But a recommendation from a Centers for Disease Control and Prevention advisory committee is key for payer coverage, and that committee has not met all year due to ongoing litigation.
The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with guidance given prior to the start of Phase 3 testing.
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The deal helps move BioNTech’s proposed acquisition of CureVac closer to completion. With the settlement, GSK said it will tender the CureVac shares it owns in support of the $1.25 billion acquisition.