There was a World Health Organization (WHO) consultation in April, 2021 (Sept, 2022 online publication ahead of Dec, 2022 print) whereby US government officials laid out strategies for the process of future mRNA vaccine approvals by the FDA. A summary of this meeting has just been published online, ahead of print.
Regulatory perspectives
- The WHO informal consultation on regulatory considerations for evaluation of the quality, safety, and efficacy of RNA-based prophylactic vaccines for infectious diseases took place 20-22 April 2021
- Only the product should be tested as long as same manufacturing process and LNP are used
- CBER decided that going forward, with new mRNA vaccine trials, ONLY the product (the final formulation)should be tested
- New products will be allowed to proceed with human testing without having a complete pre-clincial data package - as what was submitted to the FDA was cobbled together from previous studies
https://brownstone.org/articles/fda-is-using-covid-vaccines-as-a-platform-technology/
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