Rsv vaccine pref3, recombinant Pregnancy Warnings

Animal studies have not been reported. In a controlled trial, pregnant individuals who received an investigational unadjuvanted respiratory syncytial virus (RSV) vaccine that contain the same RSVPreF3 antigen as this vaccine experienced a 6.8% increase in preterm births compared to those who received a placebo. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help healthcare providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Safety has not been established during pregnancy.

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