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While the US continues making historic revisions to its vaccine guidelines, one figure has surfaced in a surprising turn: Dr. Tracy Beth Høeg, a Danish American physician and public health researcher who initially gained attention by expressing skepticism about COVID-19 vaccinations in the global health crisis and has zeroed in on potential deaths after Covid immunization in her recent tenure at the FDA.

Planned Changes to Pediatric Immunization Program

Health officials were set to reveal radical revisions to the childhood vaccine schedule recently, bringing the US with Denmark’s national calendar, it is understood – a major change that would place the US out of alignment with much of the international standard with no evidence for benefit. The announcement has been pushed back until the new year.

Instead of Vinay Prasad, Dr. Høeg is set to speak at the meeting. She was just designated interim head of the FDA’s drug evaluation center, the fifth appointee to head the office this calendar year.

Consolidating Power at the Regulatory Body

The acting appointment may indicate a tighter collaboration between the drug and biologics divisions as Dr. Høeg and Prasad strengthen their influence at the regulatory agency – and it points to a renewed priority upon dismantling previously authorized immunizations at the FDA.

Høeg has frequently advocated for discontinuing some pediatric shot schedules in the US in order to be more like the Danish model, a country with comprehensive healthcare and a population about the size of the state of Wisconsin.

In her initial comments, she has kept her attention on immunizations – usually the responsibility of Dr. Prasad, chief of the FDA’s CBER – instead of medication approval.

Questions Over Background

The appointee has little discernible background in medication creation, approval processes or administrative roles, which has been standard for former heads of the Center for Biologics Evaluation and Research. She has served at the FDA as a top consultant to the agency head and the vaccine center since earlier this year.

“She appears not to have the requisite experience” for running the CDER, stated a neurologist and psychiatrist. “She lacks experience running a scientific study. She is not versed in leading a major agency. She lacks background in pharmaceutical oversight.”

Previous directors of the center would “be deeply familiar with legal statutes and the research of medication creation”, said Dr. Janet Woodcock. “Frankly, she has not acquired the kind of background that prior appointees who ran CBER have had.”

The drug center has an immense workload at the agency, she pointed out.

“Everybody just zeroes in on the novel medication approvals, but the off-patent medication office clears numerous generic medications. There is also a biosimilars program, non-prescription drug unit and other areas, and all of those must be managed,” Woodcock noted. “The thing you neglect, that is the part that I always told people is going to cause problems.”

Additionally, a major leadership component to the role, which supervises more than 5,000 employees. “It’s a enormous management job, if you do it right,” Woodcock said.

Official Statement and Controversial Initiatives

In response to questions about Dr. Høeg's fitness for the role and whether this assignment represents increased cooperation among regulatory chiefs on immunizations, a representative responded that the “concerns are based on inaccurate assumptions”.

“Her experience matches the duties of her job,” the representative stated, noting the time Høeg spent counseling the FDA commissioner on “medication safety and regulatory science, including predictive safety algorithms and shot safety tracking”.

As the temporary head, Høeg inherits the commissioner’s controversial priority voucher program, a controversial one-day therapy clearance system that reportedly troubled her preceding directors. “By what process are these drugs being picked for this expedited pathway? Who takes the choices?” Dr. Howard asked. “There is a lot of lack of transparency happening at the regulatory body right now.”

Overall, he said, “the Food and Drug Administration looks to be trending towards less stringent oversight of all drugs, except for shots.”

Documented Track Record on Vaccines

Regarding vaccines, Høeg has a more documented, if concerning, track record, Howard have noted. She released a research paper using unverified public submissions to determine the rate of heart inflammation after COVID-19 vaccination. She advised the state of Florida top health official Joseph Ladapo, who allegedly have modified findings to suggest Covid vaccinations are pose a greater threat than they are.

Part of her “desired changes” for the current federal leadership included revising regulations for recently developed shots and halting “unnecessary” vaccines, she said post-election on a online show. At the agency, Høeg has allegedly suggested preventing adolescent males from obtaining COVID-19 vaccines.

“She’s an all-around true believer who begins with her conclusions and works backwards to retrofit the data in a extremely deceptive, untruthful fashion,” Howard argued.

Taking Control and a “Revenge Tour”

Dr. Høeg became part of other contrarians, {like|