Who is Vinay Prasad? US FDA vaccine chief to step down next month

Core Viewpoint - Dr. Vinay Prasad, head of the FDA's division of vaccines and gene therapies, is resigning to return to academia after implementing significant reforms during his tenure [1][2]. Group 1: FDA Reforms and Achievements - Prasad implemented four major reforms: a 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified COVID vaccine framework, and a new plausible mechanism framework for ultra-rare diseases [2]. - Under Prasad's leadership, the FDA achieved a record number of approvals in December, indicating a productive year [3]. Group 2: Industry Reactions - The announcement of Prasad's departure led to a rise in biotech shares, with analysts describing it as a "sigh of relief" for the biotech industry [6]. - Companies like UniQure NV and Regenxbio Inc. saw significant stock price increases of up to 70% and 29%, respectively, following the news, reflecting investor optimism regarding regulatory changes [9]. Group 3: Controversies and Criticisms - Prasad faced criticism for overruling scientific review staff and adopting a confrontational approach, which some believed hindered scientific innovation and slowed drug approvals [7]. - His decision not to review Moderna Inc.'s application for a new flu vaccine was met with backlash, although the FDA later reversed this decision [8].