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While America proceeds with unprecedented adjustments to its vaccination recommendations, an unexpected name has surfaced somewhat surprisingly: Tracy Beth Høeg, a Danish American sports medicine doctor and public health researcher who initially gained attention by expressing skepticism about COVID-19 vaccines in the global health crisis and has zeroed in on potential fatalities after COVID-19 immunization in her recent position at the US Food and Drug Administration (FDA).

Scheduled Changes to Childhood Vaccine Program

Agency leaders had intended to reveal major revisions to the childhood immunization program recently, aligning the US with Denmark’s vaccine program, according to reports – a significant shift that would place the US at odds with many the world with insufficient data for benefit. This reveal has been postponed until the new year.

In place of the director of the vaccine center, Dr. Høeg is scheduled to speak at the meeting. She was newly appointed interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to run the office this calendar year.

Consolidating Power at the FDA

This interim role could signify a strengthened alliance between the pharmaceutical and biologics divisions as Høeg and Dr. Prasad consolidate power at the FDA – and it signals a renewed priority upon rolling back long-standing vaccines at the FDA.

Høeg has often pushed for ending some childhood immunization guidelines in the US to become more in line with the Danish model, a country with nationalized medicine and a number of inhabitants approximately the size of the state of Wisconsin.

In her initial comments, she has kept her attention on immunizations – usually the domain of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of medication approval.

Concerns Over Background

Høeg has no apparent background in drug development, approval processes or management, which has been customary for past directors of the Center for Biologics Evaluation and Research. She has served at the FDA as a top consultant to the agency head and the vaccine center since spring.

“It seems she lacks to have the necessary background” for leading the drug-regulation department, stated Dr. Jonathan Howard. “She’s never run a randomized controlled trial. She has no expertise in managing a large organization. She is not an expert in drug approvals.”

Past heads of CBER would “understand laws and regulations and the underlying principles of pharmaceutical innovation”, commented a former acting FDA commissioner. “Objectively, she lacks the kind of background that former directors who led CBER have had.”

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

“Everybody just focuses on the innovative therapies, but the generic drug division authorizes thousands of generic medications. There is also a biosimilars program, over-the-counter program and more, and each of these have to be managed,” she explained. “The responsibility you don’t keep your eye on, that is the part that I always told people is going to bite you.”

There is also, a significant leadership aspect to the role, which manages in excess of 5,000 personnel. “It is a huge management job, if you execute it properly,” Woodcock added.

Agency Reaction and Disputed Programs

Regarding questions about Dr. Høeg's fitness for the role and whether this selection signifies greater collaboration among agency officials on vaccines, a representative responded that the “questions are based on flawed presumptions”.

“Her resume is consistent with the functions of her job,” the representative said, pointing to the months Høeg spent guiding the FDA commissioner on “drug safety and regulatory science, including computational safety modeling and immunization monitoring”.

In her interim role, Høeg assumes responsibility for the commissioner’s recently launched priority voucher program, a contentious expedited drug-approval program that reportedly concerned her predecessors. “How are these therapies being chosen for this voucher program? Who takes the choices?” Howard said. “There’s a lot of confidentiality occurring at the agency right now.”

In general, he stated, “the agency appears to be shifting towards less stringent oversight of all drugs, with the exception of vaccines.”

Established Track Record on Vaccines

Regarding immunizations, Dr. Høeg has a more documented, if problematic, past, Howard said. She published a research paper using unconfirmed crowd-sourced reports to determine the rate of myocarditis after COVID-19 immunization. She advised the Florida surgeon general Joseph Ladapo, who allegedly have altered data to imply COVID-19 vaccines are pose a greater threat than they are.

Included in her “wish list” for the current federal leadership featured changing regulations for new vaccines and ending “optional” vaccines, she stated after the election on a online show. At the agency, Dr. Høeg has according to sources proposed preventing young men from obtaining Covid vaccinations.

“She is an thorough true believer who commences with her conclusions and reverse-engineers to accommodate the science in a very deceptive, untruthful fashion,” Howard said.

Taking Control and a “Campaign of Retribution”

Dr. Høeg joined fellow skeptics, {like|