US Label For COVID-19 Vaccine Will Not Recommend Against Use In Pregnancy
Executive Summary
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.
You may also be interested in...
PK Evaluation In Pregnancy: Can HIV Show A Way Forward?
US FDA workshop on efforts to advance pharmacokinetic data collection in pregnant women highlights the (slow-moving) antiretroviral experience, but COVID therapies show that regulatory receptiveness is a poor match for recruitment and liability concerns.
Statin Label Change May Signal Broader US FDA Shift On Drug Use During Pregnancy
Agency is removing warning contraindicating use of statins during pregnancy; the move comes after FDA has permitted COVID-19 vaccination of pregnant women and amidst push for their enrollment in clinical trials.
Pregnant Women In Clinical Trials: Investigators Should Justify Exclusion, NIH Official Says
Enrollment-boosting strategy backed by industry rep at Duke-Margolis meeting as FDA official suggests having sponsors develop study plans for pregnant and lactating women with ‘elements of’ the requirement for pediatric studies.