Stipulated Order Showing FDA’s Off-Label Use of Vaccines During Pregnancy

ICAN submitted a Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA), requesting copies of the clinical trials it relied upon when licensing any influenza vaccine for use in pregnant women. When the FDA failed to respond to this request an appeal, and lawsuit, ensued. In the end, as seen from the document which ended the lawsuit, it is clear the FDA has not licensed any influenza vaccine as an indicated use for pregnant women, let alone conducted or required any pharmaceutical company to conduct any clinical trial which supports the safety of injecting pregnant women with the influenza vaccine.

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