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FDA delays decision on Moderna’s RSV vaccine

May 13, 2024

The company said the FDA would not be able to complete its review of the mRNA-1345 vaccine by the scheduled date of 12th May due to “administrative constraints”, causing nervousness among investors that led to a near-3% decline in its share price.

The fear for shareholders is that a delay could mean that mRNA-1345 won’t be ready to roll out in the US in time for the forthcoming RSV season, which starts in the autumn, although, Moderna said in a statement that the FDA has said it hopes to complete the review by the end of this month.

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