The Challenges of Warp Speed: FDA, Administration Not Always On Same Page
Administration suggests Operation Warp Speed vaccines come with US FDA review speed advantage, but the agency backtracks on that assertion. FDA may need to get creative to ensure it has enough staff to quickly review all vaccines, expert says.
You may also be interested in...
Commissioner Hahn says FDA will see data as it is compiled to speed review; enrollment criteria raises some eyebrows since Moderna plans to exclude patients with known history of SARS-CoV-2 infection from Phase III. The agency’s guidance on COVID-19 vaccine trials says that such exclusions are not necessary since screening is unlikely when a product would be delivered post-market.
Supply agreement with the Health and Human Services Department and the Department of Defense reflects a profitable per dose price of $19.50 for an initial batch of 100 million doses of the vaccine candidate, pending FDA authorization or approval.
Pink Sheet Podcast: Finally, A US FDA User Fee Deal, ‘Pandemic Is Over’ Take-Aways, Tpoxx Development Issues
Pink Sheet reporters and editor discuss the impact of the long wait for a user fee deal to be negotiated, how the FDA will interpret President Biden’s statement that the COVID-19 pandemic is over, and concerns with the clinical development of the monkeypox treatment Tpoxx.