FLUBLOK® (Influenza Vaccine) U.S. label updated with one of Sanofi’s largest flu vaccine safety studies in pregnant individuals

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On Oct. 16, 2024, The U.S. Food and Drug Administration (FDA) announced it had updated the label for FLUBLOK (Influenza Vaccine) to include data from a new safety study involving pregnant individuals 18 years and older, in time to inform those hoping to comply with U.S. Centers for Disease Control and Prevention (CDC) recommendations to receive their annual flu vaccine ideally before the end of October.

The results from the study of more than 48,000 pregnant individuals across multiple flu seasons were published in American Journal of Obstetricians and Gynecologists (AJOG) Global Reports and demonstrated that FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.

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Source: Sanofi
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