1. Pink Sheet

US Label For COVID-19 Vaccine Will Not Recommend Against Use In Pregnancy

 
• By Sue Sutter

Although UK labeling for the Pfizer/BioNTech vaccine recommends against use in women who are pregnant or breastfeeding, the US FDA’s labeling under an emergency use authorization is not expected to follow suit; agency says developmental and reproductive toxicity studies for some early candidates are nearing completion, but data will not available for EUA decision-making.

Doctor examining a pregnant woman
The FDA's policy generally is not to recommended against use of vaccines in pregnant women. • Source: Shutterstock

Labeling for the first COVID-19 vaccines expected to receive US Food and Drug Administration emergency authorization will not recommend against use in pregnant or lactating women, despite the absence of efficacy and safety data in this population.

The approach to pregnancy labeling will be a point of differentiation between the UK Medicines and Healthcare products Regulatory Agency’s recent emergency use authorization of Pfizer Inc

In a 4 December presentation to the National Vaccine Advisory Committee, Jeff Roberts, associate director for medical countermeasures and scientific affairs in the FDA’s Office of Vaccines Research and Review, said the agency has had some discussions and external questions

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