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While the US undertakes historic changes to its immunization schedules, a particular individual has surfaced unexpectedly: Høeg, a US-based sports physician and epidemiologist who first made her name by expressing skepticism about coronavirus shots during the global health crisis and has focused upon potential fatalities following COVID-19 vaccination in her brief tenure at the US Food and Drug Administration (FDA).

Planned Shifts to Childhood Vaccine Schedule

Agency leaders were set to reveal radical revisions to the pediatric immunization program earlier this month, bringing the US with Denmark’s immunization schedule, according to reports – a substantial departure that would put the US at odds with much of the world with insufficient data for public health gain. This reveal has been delayed until the next year.

In place of the director of the vaccine center, Dr. Høeg is set to speak at the event. She was just designated acting director of the FDA’s CDER, the fifth appointee to head the division this year.

A Shift at the FDA

The acting appointment may indicate a tighter collaboration between the drug and biologics branches as Høeg and Prasad solidify control at the regulatory agency – and it signals a greater focus upon rolling back already-approved immunizations at the FDA.

The new acting director has often pushed for halting specific pediatric immunization guidelines in the US in order to be more in line with Denmark's approach, a country with universal health coverage and a population approximately the population of Wisconsin’s.

To date public appearances, she has kept her attention on vaccines – typically the responsibility of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to medication approval.

Questions Over Background

Høeg has no obvious track record in pharmaceutical research, regulation or leadership, which has been typical for past heads of the biologics center. She has been employed at the FDA as a top consultant to the agency head and CBER since March.

“She appears not to have the necessary background” for running the drug-regulation department, said Dr. Jonathan Howard. “She has not conducted a scientific study. She is not versed in running a large organization. She is not an expert in industry regulation.”

Past commissioners of CBER would “understand legal statutes and the underlying principles of medication creation”, noted Dr. Janet Woodcock. “Objectively, she has not acquired the sort of resume that prior appointees who led the center have had.”

This division has an immense workload at the agency, the former commissioner stated.

“The public just focuses on the innovative therapies, but the off-patent medication office approves numerous generic medications. There’s a biosimilars division, non-prescription drug unit and so forth, and each of these must be supervised,” Woodcock said. “The area you don’t keep your eye on, that is the part that I always told people is going to cause problems.”

Additionally, a major administrative component to the job, which manages in excess of 5,000 staff members. “It is a enormous administrative position, if you do it right,” she concluded.

Response and Controversial Programs

Regarding questions about Dr. Høeg's qualifications and whether this selection represents greater collaboration among FDA leaders on vaccines, a representative said that the “questions are based on flawed presumptions”.

“Her experience matches the functions of her role,” the spokesperson said, pointing to the period Dr. Høeg spent guiding the FDA commissioner on “pharmaceutical safety and approval science, including predictive safety algorithms and immunization monitoring”.

As the temporary head, Dr. Høeg inherits the commissioner’s controversial expedited review system, a disputed one-day medication authorization process that reportedly concerned her preceding directors. “How are these medications being picked for this voucher program? Who is making the calls?” Howard said. “There’s a lot of lack of transparency happening at the agency right now.”

In general, he stated, “the Food and Drug Administration seems to be moving towards less stringent regulations of most medications, aside from shots.”

Documented History on Immunizations

With vaccines, Høeg has a clearer, if troubling, track record, Howard said. She authored a research paper using non-validated volunteer-provided data to determine the incidence of heart inflammation after Covid immunization. She counseled the state of Florida chief medical officer Joseph Ladapo, who was said to have changed statistics to suggest Covid vaccines are riskier than they are.

Part of her “policy goals” for the incoming administration featured changing rules for new vaccines and discontinuing “non-essential” immunizations, she stated after the election on a podcast. At the FDA, Dr. Høeg has reportedly suggested barring adolescent males from obtaining COVID-19 vaccinations.

“She is an all-around dogmatist who begins with her preconceived notions and tailors the evidence to accommodate the data in a extremely misleading, dishonest manner,” Howard stated.

Taking Control and a “Revenge Tour”

Dr. Høeg joined fellow skeptics, {like|