Moderna’s COVID-19 Vaccine To Get Real-Time Data Assessment By US FDA
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.
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Stephen Hahn also said the expedited approval process could be even more efficient.
Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.
The possibility, which seems driven by the culture of the times, may be legally possible, but experts raised many practical concerns.