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Given that the US proceeds with sweeping revisions to its vaccination guidelines, one figure appears somewhat surprisingly: Tracy Beth Høeg, a Danish American sports physician and public health researcher who first made her name by expressing skepticism about COVID-19 vaccines in the global health crisis and has zeroed in on potential deaths after COVID-19 immunization in her recent time at the FDA.

Scheduled Changes to Pediatric Vaccine Schedule

Public health authorities planned to announce radical revisions to the childhood vaccination calendar earlier this month, synchronizing the US with Denmark’s national calendar, sources say – a significant shift that would put the US out of alignment with much of the global community with little proof for benefit. The announcement has been delayed until the coming year.

Rather than Vinay Prasad, Høeg is scheduled to address the audience at the meeting. She was just designated temporary leader of the FDA’s drug evaluation center, the fifth person to lead the office this calendar year.

Consolidating Power at the Regulatory Body

This interim role could signify a tighter collaboration between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad consolidate power at the agency – and it signals a greater focus upon rolling back long-standing vaccines at the FDA.

The new acting director has repeatedly called for halting specific pediatric shot schedules in the US to become more similar to Denmark's approach, a country with nationalized medicine and a number of inhabitants roughly the population of the state of Wisconsin.

In her initial statements, she has continued to focus on vaccination policy – traditionally the purview of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to drug regulation.

Doubts Over Qualifications

Høeg has no apparent track record in medication creation, oversight or management, which has been typical for former heads of the Center for Biologics Evaluation and Research. She has worked at the FDA as a top consultant to the FDA chief and the vaccine center since spring.

“She appears not to have any of the qualifications” for leading the drug-regulation department, said Dr. Jonathan Howard. “She lacks experience running a scientific study. She lacks experience in leading a major agency. She lacks background in industry regulation.”

Former heads of CBER would “be deeply familiar with laws and regulations and the science of medication creation”, commented a former acting FDA commissioner. “Objectively, she lacks the kind of background that prior appointees who headed CBER have had.”

This division has an immense range of responsibilities at the agency, Woodcock pointed out.

“The public just focuses on the innovative therapies, but the off-patent medication office clears thousands of generic medications. There is also a biologic copycat branch, over-the-counter program and so forth, and every single one must be managed,” Woodcock explained. “The responsibility you overlook, that is precisely what that I always told people is going to bite you.”

Additionally, a substantial management aspect to the position, which manages in excess of 5,000 employees. “It is a huge management job, if you execute it properly,” Woodcock concluded.

Agency Reaction and Contentious Initiatives

When asked about inquiries about Dr. Høeg's credentials and whether this selection indicates increased cooperation among regulatory chiefs on vaccines, a representative responded that the “concerns are based on incorrect assumptions”.

“Her resume aligns with the responsibilities of her position,” the spokesperson said, pointing to the months Høeg spent guiding the FDA commissioner on “drug safety and oversight research, including computerized risk analysis and vaccine surveillance”.

In her interim role, Høeg takes over the commissioner’s new priority voucher program, a disputed expedited medication authorization process that reportedly concerned her former heads. “By what process are these medications being chosen for this voucher program? Who takes the choices?” Howard asked. “There is a lot of confidentiality occurring at the agency right now.”

Overall, he said, “the Food and Drug Administration looks to be trending towards laxer rules of most medications, aside from shots.”

Documented Track Record on Vaccines

Concerning vaccines, Høeg has a more documented, if problematic, track record, critics said. She authored a study using unconfirmed volunteer-provided data to determine the incidence of myocarditis following Covid vaccination. She counseled the state of Florida surgeon general Joseph Ladapo, who allegedly have modified findings to suggest Covid vaccinations are riskier than they are.

Included in her “policy goals” for the incoming government encompassed changing rules for new vaccines and discontinuing “unnecessary” vaccines, she said after the election on a audio program. At the agency, Dr. Høeg has allegedly suggested preventing adolescent males from receiving Covid vaccinations.

“She’s an complete dogmatist who commences with her conclusions and reverse-engineers to retrofit the science in a very misleading, fraudulent fashion,” Howard said.

Gaining Influence and a “Campaign of Retribution”

Dr. Høeg joined fellow contrarians, {like|