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While the United States undertakes sweeping revisions to its vaccine schedules, an unexpected name appears somewhat surprisingly: Tracy Beth Høeg, a Danish American physician and epidemiologist who first made her name by questioning coronavirus vaccinations in the global health crisis and has zeroed in on alleged fatalities after Covid immunization in her brief time at the US Food and Drug Administration (FDA).

Scheduled Changes to Pediatric Vaccine Program

Health officials planned to announce sweeping revisions to the pediatric immunization program in December, aligning the US with the Danish national calendar, according to reports – a major change that would place the US at odds with much of the international standard with insufficient data for benefit. This reveal has been delayed until the new year.

Rather than the top vaccines chief, Tracy Beth Høeg is listed to present at the event. She was newly appointed acting director of the FDA’s drug evaluation center, the fifth person to lead the division this calendar year.

Consolidating Power at the FDA

This interim role might represent a tighter collaboration between the drug and vaccine centers as Høeg and Prasad solidify control at the FDA – and it signals a greater focus upon dismantling previously authorized vaccines at the FDA.

Høeg has frequently advocated for ending certain childhood immunization guidelines in the US so as to align more in line with Denmark, a nation with universal health coverage and a population roughly the population of Wisconsin’s.

In her initial comments, she has continued to focus on immunizations – traditionally the purview of Dr. Prasad, head of the FDA’s CBER – rather than drug regulation.

Questions Over Background

Høeg has no apparent background in medication creation, approval processes or leadership, which has been standard for former directors of the Center for Biologics Evaluation and Research. She has worked at the FDA as a senior adviser to the FDA chief and the vaccine center since March.

“She appears not to have any of the qualifications” for overseeing the drug-regulation department, remarked a neurologist and psychiatrist. “She lacks experience running a scientific study. She has no expertise in leading a large organization. She is not an expert in drug approvals.”

Previous directors of the center would “be deeply familiar with legal statutes and the underlying principles of medication creation”, said Dr. Janet Woodcock. “Frankly, she has not acquired the sort of resume that previous people who headed CBER have had.”

CDER has an immense workload at the FDA, Woodcock pointed out.

“The public just zeroes in on the new drug program, but the generic drug division authorizes a multitude of generic medications. There’s a biologic copycat branch, over-the-counter program and other areas, and all of those need to be supervised,” Dr. Woodcock noted. “The thing you overlook, that is precisely what that I always told people is going to bite you.”

Additionally, a substantial leadership aspect to the job, which supervises over 5,000 employees. “It’s a huge management job, if you execute it properly,” Woodcock added.

Agency Reaction and Contentious Programs

In response to questions about Dr. Høeg's qualifications and whether this appointment represents more teamwork among agency officials on vaccines, a press secretary said that the “concerns stem from inaccurate assumptions”.

“Her resume aligns with the duties of her job,” the spokesperson said, pointing to the time Dr. Høeg spent counseling the FDA commissioner on “medication safety and oversight research, including computational safety modeling and vaccine surveillance”.

As acting director, Høeg assumes responsibility for the commissioner’s new priority voucher program, a disputed one-day drug-approval program that apparently troubled her predecessors. “By what process are these medications being picked for this voucher program? Who makes the choices?” Howard asked. “There is a lot of confidentiality occurring at the FDA right now.”

Overall, he stated, “the Food and Drug Administration looks to be trending towards laxer regulations of pharmaceuticals, with the exception of shots.”

Documented Track Record on Vaccines

Regarding vaccines, Dr. Høeg has a more documented, if problematic, track record, critics observe. She authored a study using non-validated public submissions to assess the frequency of myocarditis after Covid immunization. She advised the Florida chief medical officer Joseph Ladapo, who was said to have altered data to suggest COVID-19 vaccines are pose a greater threat than they are.

Included in her “wish list” for the incoming federal leadership featured revising rules for novel immunizations and halting “non-essential” immunizations, she said following the vote on a podcast. At the FDA, Høeg has allegedly suggested preventing adolescent males from obtaining Covid vaccines.

“She’s an all-around ideologue who begins with her preconceived notions and reverse-engineers to fit the evidence in a highly deceptive, fraudulent manner,” Howard stated.

Consolidating Power and a “Campaign of Retribution”

Dr. Høeg joined other skeptics, {like|