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While the United States proceeds with historic changes to its immunization guidelines, one figure has emerged in a surprising turn: Dr. Tracy Beth Høeg, a Danish American sports medicine doctor and epidemiologist who first made her name by questioning Covid shots during the pandemic and has zeroed in on alleged fatalities following Covid immunization in her brief position at the US Food and Drug Administration (FDA).

Planned Overhauls to Childhood Immunization Program

Health officials planned to unveil radical revisions to the childhood vaccine schedule in December, aligning the US with Denmark’s vaccine program, according to reports – a major change that would put the US at odds with a large portion of the international standard with insufficient data for benefit. The planned update has been delayed until the next year.

Instead of Vinay Prasad, Høeg is listed to address the audience at the event. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to head the office this year.

A New Direction at the Regulatory Body

Høeg's temporary position might represent a tighter collaboration between the pharmaceutical and biologics branches as Dr. Høeg and Prasad solidify control at the FDA – and it suggests a greater focus upon rolling back previously authorized vaccines at the FDA.

Høeg has frequently advocated for discontinuing specific childhood vaccine recommendations in the US to become more similar to the Danish model, a country with nationalized medicine and a population about the population of Wisconsin’s.

To date statements, she has kept her attention on immunizations – typically the purview of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to pharmaceutical oversight.

Concerns Over Qualifications

Høeg has no apparent background in medication creation, regulation or leadership, which has been standard for past leaders of the biologics center. She has been employed at the FDA as a senior adviser to the FDA chief and CBER since spring.

“She appears not to have any of the qualifications” for leading the pharmaceutical oversight division, stated Dr. Jonathan Howard. “She lacks experience running a scientific study. She lacks experience in running a sizeable institution. She lacks background in drug approvals.”

Past commissioners of the center would “be deeply familiar with legal statutes and the research of drug development”, said Dr. Janet Woodcock. “Clearly, she lacks the type of experience that previous people who ran the center have had.”

The drug center has an immense portfolio at the FDA, Woodcock stated.

“Many people just focuses on the novel medication approvals, but the off-patent medication office approves numerous off-brand pharmaceuticals. There is also a biosimilars program, non-prescription drug unit and other areas, and each of these need to be supervised,” Woodcock explained. “The area you overlook, that is the part that I always told people is going to cause problems.”

Additionally, a major management component to the position, which manages in excess of 5,000 employees. “It is a massive management job, if you do it right,” she added.

Agency Reaction and Controversial Programs

Regarding inquiries about Dr. Høeg's qualifications and whether this selection indicates more teamwork among regulatory chiefs on vaccines, a representative said that the “questions stem from inaccurate presumptions”.

“This background is consistent with the duties of her role,” the spokesperson explained, noting the period Høeg spent counseling the FDA commissioner on “pharmaceutical safety and regulatory science, including computerized risk analysis and shot safety tracking”.

As the temporary head, Høeg takes over the commissioner’s new expedited review system, a controversial one-day therapy clearance system that apparently concerned her former heads. “How are these drugs being picked for this voucher program? Who takes the choices?” Dr. Howard said. “There’s a lot of secrecy occurring at the regulatory body right now.”

In general, he remarked, “the FDA seems to be moving towards less stringent rules of most medications, with the exception of vaccines.”

Public Past Work on Immunizations

Concerning vaccines, Dr. Høeg has a more documented, if troubling, track record, critics have noted. She published a research paper using unconfirmed volunteer-provided data to determine the frequency of myocarditis following Covid vaccination. She consulted for the Florida chief medical officer Dr. Joseph Ladapo, who reportedly have changed statistics to indicate COVID-19 vaccines are more dangerous than they are.

Included in her “wish list” for the incoming federal leadership encompassed altering rules for new vaccines and discontinuing “non-essential” immunizations, she stated following the vote on a online show. At the FDA, Høeg has reportedly proposed excluding teenage boys from receiving Covid vaccines.

“She is an all-around ideologue who starts off with her preconceived notions and works backwards to fit the evidence in a extremely disingenuous, dishonest fashion,” Dr. Howard stated.

Gaining Influence and a “Campaign of Retribution”

Høeg aligned with other skeptics, {like|