FDA appoints Dr. Vinay Prasad to lead vaccine and biologics division amid controversy
Shreeaa Rathi | TIMESOFINDIA.COM | May 06, 2025, 20:49 IST
( Image credit : AP )
In a significant shift within the US FDA, Dr. Vinay Prasad has been appointed to head the biologics division, stepping into the role after Dr. Peter Marks' departure. Renowned for his critical insights into vaccine strategies, Prasad's leadership may herald a new era in vaccine oversight, particularly as the biotechnology sector reacts with mixed feelings.
The U.S. Food and Drug Administration (FDA) has appointed Dr. Vinay Prasad, a renowned hematologist-oncologist and professor at the University of California, San Francisco, to lead its Center for Biologics Evaluation and Research (CBER). This division is responsible for overseeing vaccines and biologic medicines in the United States.
Dr. Prasad, who became widely known during the COVID-19 pandemic for his outspoken criticism of government policies and vaccine strategies, is taking over from Dr. Peter Marks. Dr. Marks had a prominent role in leading Operation Warp Speed, the government’s initiative to rapidly develop COVID-19 vaccines. His resignation in March, which was accompanied by a scathing letter about the U.S. Department of Health and Human Services’ approach to vaccine safety, marked the end of an era for CBER.
In contrast, Dr. Prasad's appointment has sparked mixed reactions, particularly in the biotechnology sector. Prasad has long been a critic of the accelerated vaccine development efforts, including Operation Warp Speed, and has questioned policies regarding school shutdowns, mask mandates, and COVID-19 booster shots. On social media and through his blog, Prasad has been a vocal advocate for greater transparency and evidence-based decision-making in health policy.
Dr. Prasad's views on vaccine safety and approval processes have made him a polarizing figure. For instance, he has publicly challenged the FDA’s use of accelerated approval pathways for certain medicines, including Sarepta Therapeutics’ gene therapy treatment for Duchenne muscular dystrophy. Prasad has questioned the clinical benefits of these treatments, despite their high cost and potential risks.
His appointment comes at a time when the FDA is reconsidering its approach to future vaccines. The agency has indicated that it will impose new requirements for vaccines, including placebo-controlled trials, a move that could lead to more rigorous scrutiny of vaccine safety and effectiveness. Public health officials are also reevaluating recommendations for COVID-19 vaccinations in children, a subject Prasad has previously criticized, given the lower risk of severe disease in younger populations compared to older adults and those with weakened immune systems.
While Prasad’s supporters argue that his stance on vaccine policy and his emphasis on evidence-based approaches will help improve the FDA’s oversight, biotech stocks have taken a hit following the announcement of his appointment. Sarepta Therapeutics, for example, saw its stock fall nearly 25%, reflecting the market's concerns over Prasad's critical stance toward accelerated drug approvals.
Dr. Prasad’s leadership could bring significant change to the FDA's biologics division, particularly in its oversight of gene therapies and other cutting-edge treatments. As the FDA aims to streamline the approval process for innovative medicines, Prasad's focus on ensuring that new therapies are both effective and safe could reshape the landscape for biotechnology companies. However, his "anti-establishment" reputation has left many in the industry uncertain about what lies ahead.
As the FDA continues to evolve under his leadership, Prasad's ability to balance scientific rigor with public health needs will be closely watched by both supporters and critics alike. In the coming years, his decisions could shape the future of vaccine development and approval processes in the United States.
Dr. Prasad, who became widely known during the COVID-19 pandemic for his outspoken criticism of government policies and vaccine strategies, is taking over from Dr. Peter Marks. Dr. Marks had a prominent role in leading Operation Warp Speed, the government’s initiative to rapidly develop COVID-19 vaccines. His resignation in March, which was accompanied by a scathing letter about the U.S. Department of Health and Human Services’ approach to vaccine safety, marked the end of an era for CBER.
In contrast, Dr. Prasad's appointment has sparked mixed reactions, particularly in the biotechnology sector. Prasad has long been a critic of the accelerated vaccine development efforts, including Operation Warp Speed, and has questioned policies regarding school shutdowns, mask mandates, and COVID-19 booster shots. On social media and through his blog, Prasad has been a vocal advocate for greater transparency and evidence-based decision-making in health policy.
Dr. Prasad's views on vaccine safety and approval processes have made him a polarizing figure. For instance, he has publicly challenged the FDA’s use of accelerated approval pathways for certain medicines, including Sarepta Therapeutics’ gene therapy treatment for Duchenne muscular dystrophy. Prasad has questioned the clinical benefits of these treatments, despite their high cost and potential risks.
His appointment comes at a time when the FDA is reconsidering its approach to future vaccines. The agency has indicated that it will impose new requirements for vaccines, including placebo-controlled trials, a move that could lead to more rigorous scrutiny of vaccine safety and effectiveness. Public health officials are also reevaluating recommendations for COVID-19 vaccinations in children, a subject Prasad has previously criticized, given the lower risk of severe disease in younger populations compared to older adults and those with weakened immune systems.
While Prasad’s supporters argue that his stance on vaccine policy and his emphasis on evidence-based approaches will help improve the FDA’s oversight, biotech stocks have taken a hit following the announcement of his appointment. Sarepta Therapeutics, for example, saw its stock fall nearly 25%, reflecting the market's concerns over Prasad's critical stance toward accelerated drug approvals.
Dr. Prasad’s leadership could bring significant change to the FDA's biologics division, particularly in its oversight of gene therapies and other cutting-edge treatments. As the FDA aims to streamline the approval process for innovative medicines, Prasad's focus on ensuring that new therapies are both effective and safe could reshape the landscape for biotechnology companies. However, his "anti-establishment" reputation has left many in the industry uncertain about what lies ahead.
As the FDA continues to evolve under his leadership, Prasad's ability to balance scientific rigor with public health needs will be closely watched by both supporters and critics alike. In the coming years, his decisions could shape the future of vaccine development and approval processes in the United States.