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As the US continues making historic adjustments to its immunization recommendations, a particular individual 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-19 vaccinations in the pandemic and has zeroed in on alleged fatalities following Covid immunization in her recent position at the FDA.

Proposed Shifts to Childhood Vaccine Schedule

Agency leaders were set to unveil radical changes to the pediatric vaccine schedule recently, aligning the US with Denmark’s immunization schedule, sources say – a substantial departure that would put the US out of step with a large portion of the international standard with little proof for public health gain. The announcement has been delayed until the new year.

Instead of the director of the vaccine center, Høeg is listed to speak at the event. She was newly appointed temporary leader of the FDA’s CDER, the fifth person to head the office this calendar year.

A Shift at the FDA

The acting appointment may indicate a strengthened alliance between the drug and biologics centers as Høeg and Prasad solidify control at the FDA – and it suggests a increased emphasis upon dismantling previously authorized vaccines at the FDA.

Høeg has often pushed for discontinuing certain pediatric vaccine recommendations in the US so as to align more like Denmark's approach, a society with nationalized medicine and a population about the size of Wisconsin’s.

So far comments, she has persisted in emphasizing on vaccines – traditionally the purview of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of medication approval.

Doubts Over Expertise

Høeg has no obvious experience in medication creation, approval processes or management, which has been customary for former directors of the Center for Biologics Evaluation and Research. She has been employed at the FDA as a top consultant to the agency head and the vaccine center since earlier this year.

“She appears not to have any of the qualifications” for leading the drug-regulation department, said a neurologist and psychiatrist. “She’s never run a clinical trial. She has no expertise in running a major agency. She lacks background in pharmaceutical oversight.”

Former heads of the center would “grasp regulatory frameworks and the research of medication creation”, said Dr. Janet Woodcock. “Clearly, she lacks the type of experience that former directors who led the center have had.”

The drug center has an vast range of responsibilities at the FDA, the former commissioner stated.

“Many people just zeroes in on the new drug program, but the generic drug division approves thousands of generic drugs. There is also a biologic copycat branch, over-the-counter program and other areas, and all of those need to be managed,” Dr. Woodcock noted. “The area you don’t keep your eye on, that’s the thing that I always told people is going to come back to haunt you.”

There is also, a major management component to the position, which oversees more than 5,000 employees. “It is a enormous management job, if you execute it properly,” Woodcock concluded.

Agency Reaction and Contentious Policies

When asked about questions about Høeg’s fitness for the role and whether this appointment represents more teamwork among agency officials on immunizations, a spokesperson said that the “concerns stem from inaccurate assumptions”.

“This background is consistent with the functions of her position,” the spokesperson said, noting the period Dr. Høeg spent guiding the FDA commissioner on “pharmaceutical safety and approval science, including computational safety modeling and shot safety tracking”.

As acting director, Dr. Høeg assumes responsibility for the commissioner’s new priority voucher program, a controversial expedited therapy clearance system that allegedly worried her preceding directors. “By what process are these therapies being picked for this fast-track system? Who takes the decisions?” Howard said. “There is a lot of confidentiality going on at the regulatory body right now.”

Overall, he said, “the Food and Drug Administration looks to be trending towards laxer regulations of all drugs, except for vaccines.”

Documented History on Vaccines

Concerning immunizations, Høeg has a more documented, if concerning, past, Howard observe. She released a study using non-validated crowd-sourced reports to assess the frequency of heart inflammation after COVID-19 vaccination. She consulted for the state of Florida top health official Joseph Ladapo, who reportedly have modified findings to imply COVID-19 vaccinations are more dangerous than they are.

Part of her “wish list” for the current administration included altering regulations for novel immunizations and halting “optional” vaccines, she stated after the election on a podcast. At the agency, Dr. Høeg has allegedly proposed barring young men from obtaining Covid vaccinations.

“She’s an thorough dogmatist who commences with her conclusions and works backwards to retrofit the data in a highly disingenuous, untruthful manner,” Howard said.

Consolidating Power and a “Revenge Tour”

Høeg joined fellow contrarians, {like|