Dr. Vinay Prasad Replaces Ousted Peter Marks as Chief FDA Vaccine Regulator
Dr. Vinay Prasad, a hematologist-oncologist and outspoken critic of COVID-19 vaccines for children and the government’s response to the pandemic, has replaced Dr. Peter Marks at the FDA.
Dr. Vinay Prasad, a hematologist-oncologist and outspoken critic of COVID-19 vaccines for children and the government’s response to the pandemic, has replaced Peter Marks, M.D., Ph.D., as the director of the Center for Biologics Evaluation and Research (CBER), the federal agency that oversees vaccine approval.
The news sent Moderna and other pharma stocks sliding. According to Reuters, Moderna’s stock dropped 11%, while Pfizer fell by 3%. Stocks of smaller gene therapy companies such as Sarepta Therapeutics fell by as much as 27%, Endpoint News reported.
CBER, which operates under the U.S. Food and Drug Administration (FDA), oversees the approval and regulation of vaccines, gene therapies and other biologic drugs.
Prasad’s predecessor, Marks, oversaw Operation Warp Speed and the development and approval of the COVID-19 vaccines.
Prasad, a professor of Epidemiology & Biostatistics at the University of California, San Francisco, has authored over 500 scientific articles and two books. In 2022, he and newly confirmed FDA Commissioner Marty Makary co-authored an essay in The BMJ calling universal COVID-19 booster mandates “unethical.”
In a post on X, Makary praised Prasad’s background and experience. “With 500+ peer-reviewed publications and two books, Dr. Prasad brings the kind of scientific rigor, independence, and transparency we need at CBER — a significant step forward,” Makary wrote.
In a separate email to FDA staff reviewed by Endpoints News, Makary praised Prasad’s “long and distinguished history in medicine” and said he “brings a great set of skills, energy, and competence to the FDA.”
Prasad did not respond to a request from The Defender for comment. The U.S. Department of Health and Human Services (HHS) referred to Makary’s post on X.
Mixed reactions from pharma, medical experts
Reactions from the pharmaceutical industry and medical field were mixed. Endpoints News quoted Emil Kakkis, CEO of gene therapy company Ultragenyx, who said the choice of Prasad to lead CBER “reflects poorly” on Makary’s judgment and “understanding of FDA’s mission.”
Speaking to Reuters, Dr. Wallid Gellad, a professor of medicine at the University of Pittsburgh, said Prasad is “a brilliant guy with remarkable experience understanding evidence and data on drugs. He has a difficult task ahead but an opportunity to bring those talents to positively impact FDA and the American public.”
Prasad may take a significantly different approach to leading CBER compared to Marks, as he may “raise the bar for companies to get approval for new drugs,” including accelerated approvals for new treatments, Reuters reported.
According to Endpoint News, Prasad is “likely to be more conservative in his approach to CBER than Marks, given his focus on overall survival in cancer trials and calls for tightening standards for accelerated approvals.”
Marks, forced to resign from CBER in March, criticized HHS Secretary Robert F. Kennedy Jr. in his resignation letter. “It has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote.
‘Absurd’ that CDC still recommends COVID vaccines for kids
Prasad is taking the helm at CBER when the FDA is considering whether to approve annual updates to the COVID-19 vaccines for the fall cold and flu season — a process scheduled to begin next month.
Marks also garnered criticism for fast-tracking the approval of COVID-19 vaccines despite safety concerns, and later ignoring pleas from COVID-19 vaccine injury victims for help.
In a post on Substack last week, Prasad said he supported having new randomized clinical trials performed before any updates to COVID-19 shots are approved — and said it is “absurd” that the U.S. still recommends COVID-19 vaccines for children.
In a late April post, Prasad suggested that the Centers for Disease Control and Prevention (CDC) “should ABSOLUTELY remove COVID-19 from the Childhood Immunization schedule. If it stays, it shows the United States is a corrupt country.”
According to recent reports, Kennedy has advocated for the removal of COVID-19 vaccines from the childhood schedule.
In a post on X last week, Prasad praised a similar proposal by Makary for the completion of more clinical trials before new COVID-19 vaccines are approved.
Strong critic of Marks and government response to pandemic
In a 2022 op-ed published in City Journal, Prasad wrote, “public-health officials have omitted uncomfortable truths, made misleading statements, and advanced demonstrably false assertions” during the COVID-19 pandemic.
During the pandemic, Prasad criticized vaccine mandates and suggested that Moderna’s COVID-19 vaccine should no longer be administered to men under 40, citing the risk of myocarditis posed by the vaccine in this demographic group.
Prasad has also frequently targeted his predecessor in his posts. In March, Prasad wrote that Marks was “one of the most dangerous, pro-pharma regulators of the 21st century.” In a post on X that month, Prasad said Marks could be replaced “with a bobblehead doll that just stamps approval and you would have the same outcome.”
In an August 2024 post on X, Prasad said Marks and other public health regulators were “either incompetent or corrupt to authorize a booster without clinical, randomized data.”
In a 2015 paper Prasad co-authored, published in JAMA Internal Medicine, he criticized the FDA for often approving cancer drugs through an accelerated pathway, based on data that have “poor correlations with overall survival.”
In posts following the news of Prasad’s appointment to CBER, some social media users questioned Prasad’s past statements criticizing some in the health freedom movement.
A 2024 paper published in the Monash Bioethics Review, on which Prasad was the lead author, called the COVID-19 vaccine itself “a miraculous, life-saving advance.”
But Prasad has recently expressed support for Kennedy’s “Make America Healthy Again” (MAHA) agenda. In a February YouTube video, Prasad suggested Kennedy could get started in his position as health secretary by banning artificial dyes in foods and introducing better vaccine safety surveillance.
In recent weeks, public health agencies have moved to get artificial dyes out of food products and announced the launch of a new vaccine safety surveillance system.
In his February video, Prasad also cited a 2023 paper he co-authored, highlighting examples of CDC pandemic-era policies that he characterized as “non-forgivable errors.” He said Kennedy should “take a sledgehammer to the lax conflict-of-interest policies” within public health agencies.
Related articles in The Defender
HHS Ousts Peter Marks, Sending Vaccine Stocks Tumbling and Biopharma Lamenting Loss of ‘Ally’ at FDA
U.S. Will Track Vaccine Injuries in ‘Real-Time’ Using Electronic Patient Records
RFK Jr. Wants CDC to Stop Recommending COVID Shots for Kids, Inside Sources Say
Makary: FDA Won’t Approve COVID Boosters Without ‘Some Good Data’
The following is the FDA's highly injurious and fiendishly deceptive barometer for product approval:
"If this independent and unbiased review establishes that a drug's health benefits outweigh its known risks, the drug is approved for sale."
Only outweigh? So no wide margin of safety for a mass produced product? No inherent injury and death limit? No medium/long term new side effect projected discovery based on short term effects?
Very similar safety definitions seem to be inhabiting health agencies worldwide. Training doctors are being coerced/tricked into green lighting the administration of these approved toxic substances because the words "balanced" and "outweigh" imply a reasonable course of action. Yes, they too have their medical books filled with these sorts of phrases.
Dr Vinay Prasad would do very well if he replaced this awful definition for an acceptable product with something which has been considered outside of a padded room.
ARE ANY of the so called vaccines necessary in the first place Why do we need a vaccines FDA Regulatory Commission Commissioner FDA Crimes Corruption Coverups LIES Too much BIG Dirty GOV supported by Taxpayer$ Being Used Enslaved to providing funding for Depopulation Agendas Crimes Against Humanity WAKE UP