On September 27, 2006 the US House passed the Biodefense and Pandemic Vaccine and Drug Development Act of 2006 (H. R. 5533) which established the Biomedical Advanced Research and Development Authority (BARDA) within in the Department of Health and Human Services (HHS). BARDA was set up to develop advanced countermeasures to pandemic viruses and defenses against biological attacks, and build on Project BioSheild. [1]
The bill also called for HHS to establish a National Biodefense Science Board with public and private members to advise HHS on current and future trends and advances in biological and life sciences, biotechnology, and genetic engineering. [2, 3] Their positions were meant to last 3 years, this doesn’t appear to be the case for many members in the role since 2018–2023! [4]
- BARDA were responsible for coordinating the FDA’s revoking of the EUA for Hydroxychloroquine (which should have been an Expanded Access IND protocol in the first place, but FDA’s Janet Woodcock encouraged BARDA to apply for EUA instead) > WATCH
On this very same day in 2006, Alnylam Pharmaceuticals was awarded $23 from HHS to help launch their “new initiative dubbed Alnylam Biodefense” for the development of new biodefense therapies. In 2018 the FDA approved Alnylam’s first Lipid Nanoparticle (LNP) mRNA injectable product called patisiran traded as ONPATTRO™. This product grandfathered in the “safety” data for LNP technology used in the COVID-19 mRNA vaccines.