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While the United States continues making unprecedented adjustments to its vaccine schedules, an unexpected name appears somewhat surprisingly: Høeg, a US-based sports medicine doctor and epidemiologist who initially gained attention by questioning coronavirus vaccinations during the global health crisis and has zeroed in on potential fatalities after COVID-19 immunization in her brief tenure at the FDA.

Planned Changes to Childhood Immunization Program

Public health authorities were set to unveil major changes to the pediatric immunization program recently, aligning the US with the Danish immunization schedule, according to reports – a substantial departure that would place the US at odds with many the world with little proof for improved outcomes. The announcement has been postponed until the new year.

In place of Vinay Prasad, Dr. Høeg is listed to speak at the meeting. She was recently named interim head of the FDA’s CDER, the fifth individual to run the division this calendar year.

Consolidating Power at the Regulatory Body

Høeg's temporary position could signify a closer partnership between the drug and biologics branches as Dr. Høeg and Prasad consolidate power at the agency – and it suggests a greater focus upon reevaluating previously authorized immunizations at the FDA.

Høeg has repeatedly called for halting specific childhood vaccine recommendations in the US to become more like the Danish model, a country with nationalized medicine and a citizenry roughly the size of the state of Wisconsin.

So far public appearances, she has kept her attention on immunizations – typically the responsibility of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of pharmaceutical oversight.

Doubts Over Qualifications

The appointee has no apparent experience in drug development, approval processes or leadership, which has been customary for former leaders of the Center for Biologics Evaluation and Research. She has been employed at the FDA as a senior adviser to the FDA chief and CBER since March.

“She doesn’t seem to have any of the qualifications” for overseeing the drug-regulation department, remarked a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She lacks experience in running a sizeable institution. She is not an expert in industry regulation.”

Former heads of CBER would “grasp regulatory frameworks and the underlying principles of drug development”, commented Dr. Janet Woodcock. “Objectively, she doesn’t have the sort of resume that previous people who headed CBER have had.”

CDER has an enormous workload at the agency, the former commissioner pointed out.

“Everybody just zeroes in on the innovative therapies, but the generic drug division clears a multitude of generic drugs. There’s a biosimilars program, over-the-counter program and so forth, and all of those must be supervised,” Woodcock said. “The thing you overlook, that’s the thing that I always told people is going to come back to haunt you.”

Additionally, a substantial leadership element to the position, which supervises over 5,000 employees. “It’s a massive management job, if you perform it correctly,” she said.

Agency Reaction and Disputed Policies

Regarding concerns about Høeg’s credentials and whether this assignment indicates greater collaboration among agency officials on immunizations, a spokesperson responded that the “concerns rely on inaccurate assumptions”.

“This background aligns with the functions of her role,” the official stated, pointing to the time Høeg spent guiding the FDA commissioner on “medication safety and oversight research, including computational safety modeling and immunization monitoring”.

In her interim role, Dr. Høeg takes over the agency head's recently launched fast-track approval initiative, a disputed rapid therapy clearance system that allegedly concerned her predecessors. “How are these therapies being selected for this voucher program? Who is making the calls?” Dr. Howard questioned. “There’s a lot of lack of transparency occurring at the agency right now.”

Overall, he said, “the agency seems to be moving towards less stringent oversight of all drugs, except for immunizations.”

Documented Track Record on Immunizations

Concerning vaccines, Høeg has a more established, if problematic, past, critics said. She released a analysis using non-validated crowd-sourced reports to estimate the incidence of heart inflammation after Covid vaccination. She consulted for the state of Florida top health official Joseph Ladapo, who reportedly have modified findings to indicate COVID-19 vaccinations are pose a greater threat than they are.

Included in her “policy goals” for the incoming federal leadership featured revising rules for novel immunizations and halting “optional” vaccines, she stated after the election on a podcast. At the FDA, Dr. Høeg has reportedly floated the idea of preventing adolescent males from getting Covid vaccinations.

“She’s an all-around ideologue who starts off with her preconceived notions and reverse-engineers to fit the science in a extremely disingenuous, fraudulent manner,” Howard stated.

Consolidating Power and a “Push for Payback”

Dr. Høeg joined fellow dissenters, {like|