Sanofi (SNYNF, SNY) has announced that the U.S. Food and Drug Administration (FDA) has revised the labeling for FLUBLOK, their influenza vaccine. This update now includes data from a recent safety study involving pregnant individuals aged 18 and older and is provided to align with the U.S. Centers for Disease Control and Prevention (CDC) guidelines, which recommend receiving the annual flu vaccination ideally by the end of October.
The comprehensive study, which spanned multiple flu seasons and included over 48,000 pregnant individuals, confirmed that the safety profile of FLUBLOK is akin to that of a standard-dose flu vaccine, with pregnancy-related outcomes mirroring those in the general population.
Key findings from the study indicate that the most commonly reported pregnancy outcomes for the FLUBLOK Quadrivalent and standard-dose influenza vaccine (SD-IIV4) groups were as follows: eclampsia/preeclampsia (8.4% for both groups), preterm labor (3.6% and 3.5%), spontaneous abortion (3.1% and 3.0%), congenital or fetal anomalies identified during pregnancy (2.4% for both), placental abruption (0.8% and 0.7%), and stillbirth/fetal death (0.4% and 0.5%).
FLUBLOK is designed for immunization purposes to prevent diseases caused by specific influenza A and B virus strains represented by the antigens in the vaccine. It is approved for use in individuals aged 18 and older.
