The recent halting of a significant COVID-19 vaccine development project marks a pivotal shift in health policy under the new administration.
Breitbart reported that Secretary Robert F. Kennedy Jr. initiated a 90-day review period on a Biden-era contract for a new oral vaccine just days after assuming office.
In just his second week in office, Kennedy announced a temporary suspension of operations on a Vaxart Inc. project. This project was gearing up to start clinical trials for an innovative oral COVID-19 vaccine.
The pause, implemented through a 90-day stop-work order issued last Friday, affects an ongoing contract awarded under the Biden administration's Project NextGen.
This initiative, launched in 2023 with a substantial funding pool of $4.7 billion, aimed to enhance the speed and efficiency of vaccine development.
Vaxart's vaccine development, benefiting from a $460 million allocation by the Biomedical Advanced Research and Development Authority (BARDA), had already consumed $240 million in preliminary research. The remaining $230 million earmarked for upcoming clinical trials is now on hold.
The clinical trials, slated to begin the following Monday and involving 10,000 participants, are postponed. Vaxart, however, is still authorized to bill BARDA for necessary medical monitoring of participants from early trials, keeping part of the project's momentum alive.
Kennedy’s decision to review the vaccine production contracts aligns with broader shifts in health policy direction by the current administration.
President Donald Trump has already rescinded several of Biden's federal mandates concerning COVID-19 vaccinations through new executive orders.
Under the Biden administration, federal and some corporate vaccine mandates faced significant opposition, leading to protests and the termination of employees who refused vaccination.
Trump's recent policy reversals include reinstating service members dismissed for vaccine non-compliance and halting federal funding to schools mandating vaccinations.
Reflecting on the newly issued stop-work order, Kennedy expressed the need for a thorough review of past vaccine deals.
“While the Department of Health and Human Services must support pandemic preparedness, four years of the Biden administration’s failed oversight have made it necessary to review agreements for vaccine production, including Vaxart’s,” he stated.
Kennedy further emphasized his commitment to ensuring that the suspended vaccine project adheres to safety, efficacy, and fiscal responsibility. “I look forward to working with Vaxart and medical experts to ensure this work produces safe, effective, and fiscal-minded vaccine technology,” he added.
In conjunction with the contract suspension, the creation of the Make American Healthy Again Commission by President Trump places Kennedy at the helm of a team poised to tackle the root causes of America's health crisis.
This commission plans to evaluate and potentially reshape how health crises and vaccine developments are managed in the future.
As the 90-day stop-work order takes effect, stakeholders in the healthcare and pharmaceutical industries are keeping a close watch.
The outcome of this review could influence not only the future of Vaxart’s oral COVID-19 vaccine but also the trajectory of U.S. health policy in the coming years.
Kennedy's proactive approach in his initial days as secretary highlights a keen intent to oversee and potentially recalibrate the United States’ strategy on pandemic preparedness and vaccine deployment. This action aligns with his broader ambition to address systemic issues in American healthcare through a more scrutinized and methodical approach.