FDA Appoints Vaccine Critic Vinay Prasad to Lead CBER, Biotech Stocks Plummet Amid New Vaccine Trials Policy

Vinay Prasad, a noted critic of certain vaccine policies, has been appointed to lead the FDA's Center for Biologics Evaluation and Research (CBER), which oversees the approval of vaccines, cell therapies, and gene therapies. This appointment was announced by Health and Human Services Secretary Robert F. Kennedy Jr., who has also mandated that new vaccines undergo placebo-controlled trials. The appointment of Prasad, an oncologist and professor at the University of California, has led to a significant reaction in the biotech sector. The SPDR S&P Biotech ETF (XBI) dropped by 6.5% following the announcement, with stocks of major pharmaceutical companies like Moderna, Merck, Pfizer, Amgen, and AstraZeneca falling by 12%, 4.5%, 4%, 3.4%, and 2.5% respectively. Sarepta Therapeutics saw a 26% decline in its stock value. Prasad's appointment follows his public criticisms of the FDA's handling of the Covid-19 pandemic and its former leadership, particularly targeting Peter Marks, who resigned in March. Prasad has been vocal about clinical trials for new Covid-19 vaccine variants and criticized the FDA's approval of treatments like Sarepta Therapeutics' Duchenne muscular dystrophy therapy. Secretary Kennedy Jr.'s policy on placebo-controlled trials for new vaccines has raised questions about its application to annual updates of flu and Covid vaccines. The policy aims to ensure vaccines meet the 'Gold Standard of Science' in terms of safety and effectiveness.