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.

Stipulated Order Confirming Non-Compliance With 42 USC 300AA-27C

In 1986, Congress charged Health and Human Services (HHS) with the primary responsibility of ensuring vaccine safety after removing product liability from vaccine manufacturers as part of the National Childhood Vaccine Injury Compensation Act. As part of the 1986 Act, HHS is required to create a task force and submit bi-annual reports to Congress detailing actions taken to ensure vaccine safety. This stipulated order shows that HHS has not acted in its duties regarding vaccine safety, forcing 78 million American children into a vaccine program with no safety provisions.

Stipulated Order Showing That NIH And HRSA Have Not Acted In Their Duties Regarding Vaccine Safety

In 1986, Congress charged Health and Human Services (HHS) with the primary responsibility of ensuring vaccine safety after removing product liability from vaccine manufacturers as part of the National Childhood Vaccine Injury Compensation Act. As part of the 1986 Act, HHS is required to create a task force and submit bi-annual reports to Congress detailing actions taken to ensure vaccine safety. This stipulated order shows that NIH and HRSA have not acted in their duties regarding vaccine safety, forcing 78 million American children into a vaccine program with no safety provisions.

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