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Given that America continues making unprecedented changes to its vaccination guidelines, a particular individual has emerged unexpectedly: Tracy Beth Høeg, a US-based sports medicine doctor and epidemiologist who initially gained attention by questioning COVID-19 shots during the global health crisis and has focused upon possible deaths following COVID-19 immunization in her brief position at the US Food and Drug Administration (FDA).

Scheduled Changes to Childhood Immunization Schedule

Health officials were set to unveil sweeping changes to the pediatric immunization program recently, aligning the US with the Danish national calendar, according to reports – a major change that would put the US out of alignment with much of the international standard with little proof for benefit. The planned update has been pushed back until the coming year.

Instead of the director of the vaccine center, Dr. Høeg is scheduled to address the audience at the gathering. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to run the center this year.

A New Direction at the Agency

The acting appointment may indicate a closer partnership between the drug and biologics divisions as Høeg and Dr. Prasad consolidate power at the FDA – and it points to a renewed priority upon dismantling already-approved immunizations at the FDA.

Høeg has repeatedly called for halting some childhood shot schedules in the US in order to be more similar to the Danish model, a society with universal health coverage and a citizenry about the size of the state of Wisconsin.

So far comments, she has kept her attention on vaccines – traditionally the domain of Prasad, head of the FDA’s CBER – rather than pharmaceutical oversight.

Doubts Over Qualifications

Dr. Høeg has no apparent background in drug development, regulation or management, which has been customary for former leaders of the Center for Biologics Evaluation and Research. She has served at the FDA as a top consultant to the agency head and CBER since spring.

“She appears not to have any of the qualifications” for leading the drug-regulation department, remarked Jonathan Howard. “She’s never run a scientific study. She lacks experience in managing a major agency. She lacks background in pharmaceutical oversight.”

Past directors of CBER would “be deeply familiar with regulatory frameworks and the science of pharmaceutical innovation”, said a former acting FDA commissioner. “Frankly, she doesn’t have the kind of background that former directors who ran the center have had.”

The drug center has an immense range of responsibilities at the FDA, she stated.

“Everybody just focuses on the novel medication approvals, but the generic drug division clears a multitude of generic medications. There’s a biologic copycat branch, OTC medication office and so forth, and all of those need to be supervised,” Dr. Woodcock explained. “The responsibility you don’t keep your eye on, that is the part that I always told people is going to cause problems.”

Furthermore, a substantial administrative element to the role, which supervises more than 5,000 staff members. “It is a massive leadership role, if you do it right,” the former official added.

Official Statement and Controversial Policies

Regarding inquiries about Dr. Høeg's qualifications and whether this appointment represents increased cooperation among agency officials on vaccines, a representative said that the “inquiries are based on inaccurate premises”.

“Her resume aligns with the responsibilities of her position,” the representative explained, citing the time Høeg spent guiding the FDA commissioner on “medication safety and regulatory science, including predictive safety algorithms and shot safety tracking”.

As the temporary head, Dr. Høeg inherits the agency head's recently launched expedited review system, a disputed expedited therapy clearance system that allegedly concerned her preceding directors. “By what process are these drugs being picked for this voucher program? Who makes the calls?” Dr. Howard said. “There’s a lot of confidentiality going on at the agency right now.”

Overall, he said, “the Food and Drug Administration seems to be moving towards less stringent regulations of all drugs, except for immunizations.”

Documented Past Work on Vaccines

Regarding vaccines, Dr. Høeg has a more documented, if troubling, track record, Howard have noted. She published a research paper using non-validated crowd-sourced reports to determine the rate of myocarditis after Covid immunization. She advised the state of Florida top health official Dr. Joseph Ladapo, who was said to have altered data to suggest COVID-19 vaccinations are pose a greater threat than they are.

Included in her “policy goals” for the incoming administration encompassed changing guidelines for novel immunizations and halting “unnecessary” immunizations, she remarked post-election on a online show. At the FDA, Dr. Høeg has reportedly floated the idea of preventing young men from receiving COVID-19 vaccines.

“She is an all-around ideologue who starts off with her conclusions and reverse-engineers to fit the data in a highly disingenuous, fraudulent manner,” Howard argued.

Consolidating Power and a “Push for Payback”

Høeg became part of fellow contrarians, {like|