In 1986 as part of the NCVIA, HHS was required to submit bi-annual reports detailing actions taken to ensure vaccine safety. This was not done, forcing 78 million USA children into vaccine programs with no safety provisions.
Sources:
https://www.icandecide.org/ican_lawsuits/stipulated-order-showing-that-nih-and-hrsa-have-not-acted-in-their-duties-regarding-vaccine-safety/.
Activist.
https://www.icandecide.org/wp-content/uploads/2019/11/013-STIPULATION.pdf.
Judgment, PDF.