Federal officials announced a new framework for vaccine approvals, aimed to provide clarity and predictability for vaccine manufacturers, will be revealed “in the coming days.”
Makary did not reveal any specific details about the upcoming framework, but said it will outline the FDA’s approach to vaccine approvals, providing companies with a clearer understanding of regulatory expectations. Vaccines in the U.S. need Food and Drug Administration approvals before hitting the market. While they have typically been of little fanfare, more questions about vaccines has led more Americans to question their safety.
That includes the Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr. The White House previously introduced changes to the traditional process of approving updated coronavirus vaccines, typically offered in the fall.
“We want to be very transparent,” The Food and Drug Administration Commissioner Marty Makary said Thursday during the Food and Drug Law Institute Annual Conference. “We want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry how is this going to be received.”
RFK Jr. has long questioned vaccines and pushed skeptical claims about them. He has already announced placebo-controlled trials for all new vaccines and updates, including those already approved for use in the United States.
This placebo testing will involve some participants receiving the actual vaccine while others get an inert substance, such as saline, for comparison.
Traditionally, placebo-controlled trials are conducted for vaccines targeting new pathogens, while updates to existing vaccines rely on comparative studies due to ethical considerations.
Kennedy, a longtime skeptic of vaccines, argues that this new approach will enhance data transparency. However, medical experts have expressed concerns that such requirements could delay vaccine availability and spark public distrust in immunizations.
Although Kennedy claims not to be anti-vaccine, his public statements and actions often suggest otherwise.
Kennedy has raised concerns about vaccine safety, questioning potential side effects and promoting discredited theories, including the long-debunked link between vaccines and autism.
Despite his role as HHS secretary, he has advised Americans against taking medical advice from him, reflecting a complex and often contradictory stance on public health.
