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Sanofi Gets FDA Approval to Update Flu Vaccine Label With New Pregnancy Safety Data
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Sanofi Gets FDA Approval to Update Flu Vaccine Label With New Pregnancy Safety Data
Oct 16, 2024 10:52 AM

01:25 PM EDT, 10/16/2024 (MT Newswires) -- Sanofi ( SNY ) said Wednesday that the US Food and Drug Administration updated the label for influenza vaccine Flublok to incorporate data from a recent study involving over 48,000 pregnant individuals.

The study found that Flublok's safety profile is consistent with standard-dose flu vaccines and has no risk to pregnancy, the company said.

The updated label comes ahead of the US Centers for Disease Control and Prevention's recommended flu vaccination timeframe, ideally before the end of October, Sanofi ( SNY ) said.

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