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Given that the US continues making historic adjustments to its vaccine guidelines, one figure appears in a surprising turn: Høeg, a Danish American sports physician and epidemiologist who initially gained attention by expressing skepticism about Covid vaccines throughout the global health crisis and has zeroed in on possible deaths after COVID-19 immunization in her brief position at the FDA.

Proposed Changes to Pediatric Immunization Schedule

Agency leaders planned to announce major revisions to the childhood immunization program in December, bringing the US with the Danish immunization schedule, sources say – a major change that would place the US out of step with many the world with no evidence for benefit. The planned update has been delayed until the coming year.

Rather than Vinay Prasad, Tracy Beth Høeg is scheduled to address the audience at the event. She was newly appointed temporary leader of the FDA’s CDER, the fifth appointee to lead the center this calendar year.

A New Direction at the Agency

This interim role could signify a tighter collaboration between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad strengthen their influence at the FDA – and it suggests a greater focus upon dismantling previously authorized immunizations at the FDA.

The new acting director has often pushed for ending specific pediatric vaccine recommendations in the US in order to be more similar to Denmark, a nation with universal health coverage and a population approximately the population of the state of Wisconsin.

In her initial comments, she has continued to focus on immunizations – traditionally the purview of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than drug regulation.

Doubts Over Expertise

Høeg has no apparent experience in pharmaceutical research, regulation or leadership, which has been customary for previous directors of the CBER. She has been employed at the FDA as a top consultant to the commissioner and the vaccine center since earlier this year.

“She doesn’t seem to have the necessary background” for overseeing the drug-regulation department, remarked a neurologist and psychiatrist. “She lacks experience running a scientific study. She lacks experience in running a large organization. She has no expertise in pharmaceutical oversight.”

Previous heads of CBER would “grasp laws and regulations and the research of medication creation”, noted Dr. Janet Woodcock. “Objectively, she doesn’t have the sort of resume that former directors who ran CBER have had.”

CDER has an enormous range of responsibilities at the FDA, she emphasized.

“Everybody just zeroes in on the new drug program, but the generic drug division authorizes thousands of generic drugs. There’s a biosimilars division, over-the-counter program and other areas, and all of those have to be looked after,” Woodcock noted. “The responsibility you neglect, that’s the thing that I always told people is going to cause problems.”

Additionally, a substantial administrative component to the position, which manages over 5,000 staff members. “It’s a enormous leadership role, if you perform it correctly,” the former official concluded.

Response and Disputed Policies

When asked about questions about Dr. Høeg's qualifications and whether this assignment indicates greater collaboration among FDA leaders on immunizations, a spokesperson responded that the “questions stem from flawed assumptions”.

“Her resume aligns with the functions of her job,” the spokesperson stated, citing the time Høeg spent guiding the agency head on “medication safety and approval science, including predictive safety algorithms and vaccine surveillance”.

As acting director, Høeg inherits the agency head's new expedited review system, a controversial rapid therapy clearance system that apparently troubled her predecessors. “By what process are these therapies being picked for this voucher program? Who takes the calls?” Dr. Howard asked. “There’s a lot of secrecy occurring at the regulatory body right now.”

Overall, he said, “the Food and Drug Administration appears to be shifting towards less stringent rules of pharmaceuticals, aside from immunizations.”

Public Track Record on Immunizations

With immunizations, Høeg has a more documented, if troubling, track record, some experts said. She authored a research paper using unverified volunteer-provided data to estimate the rate of myocarditis after COVID-19 immunization. She counseled the Florida chief medical officer Dr. Joseph Ladapo, who was said to have altered data to indicate Covid vaccinations are riskier than they are.

Part of her “desired changes” for the new administration encompassed changing guidelines for recently developed shots and ending “non-essential” vaccines, she stated following the vote on a online show. At the FDA, Høeg has reportedly proposed excluding young men from obtaining Covid vaccines.

“She is an thorough true believer who starts off with her preconceived notions and tailors the evidence to fit the evidence in a very misleading, fraudulent manner,” Dr. Howard argued.

Taking Control and a “Revenge Tour”

Høeg aligned with fellow skeptics, {like|