FDA Updates Sanofi's FLUBLOK Vaccine Label With New Safety Data For Pregnant Individuals

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(RTTNews) - Sanofi (SNYNF, SNY) said that the U.S. Food and Drug Administration has 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 demonstrated FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.

According to the company's study results, the most frequently reported pregnancy outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups respectively were eclampsia/preeclampsia (8.4% in both cohorts), preterm labor (3.6% and 3.5%), spontaneous abortion (3.1% and 3.0%), congenital/fetal anomalies detected during pregnancy (2.4% in both cohorts), placental abruption (0.8% and 0.7%) and stillbirth/fetal death (0.4% and 0.5%).

FLUBLOK is a vaccine indicated for immunization for the prevention of disease caused by influenza A and B strains represented by antigens contained in the vaccine. FLUBLOK is given to people 18 years of age and older.

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