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Given that the United States undertakes sweeping changes to its vaccine recommendations, a particular individual has surfaced unexpectedly: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by expressing skepticism about Covid shots in the global health crisis and has focused upon alleged deaths following COVID-19 immunization in her brief time at the US Food and Drug Administration (FDA).

Planned Overhauls to Childhood Vaccine Schedule

Agency leaders planned to announce sweeping revisions to the childhood vaccination calendar recently, aligning the US with Denmark’s vaccine program, sources say – a significant shift that would put the US at odds with much of the international standard with no evidence for benefit. This reveal has been delayed until the next year.

In place of the director of the vaccine center, Høeg is listed to address the audience at the meeting. She was recently named temporary leader of the FDA’s drug evaluation center, the fifth individual to lead the center this year.

A New Direction at the Agency

This interim role could signify a closer partnership between the pharmaceutical and vaccine centers as Dr. Høeg and Dr. Prasad strengthen their influence at the agency – and it suggests a increased emphasis upon dismantling already-approved vaccines at the FDA.

Dr. Høeg has often pushed for ending specific pediatric immunization guidelines in the US to become more similar to Denmark, a country with comprehensive healthcare and a citizenry approximately the size of Wisconsin’s.

To date public appearances, she has kept her attention on vaccines – usually the responsibility of Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than drug regulation.

Questions Over Expertise

Høeg has no apparent experience in drug development, approval processes or leadership, which has been standard for past leaders of the CBER. She has been employed at the FDA as a top consultant to the commissioner and the vaccine center since earlier this year.

“She appears not to have any of the qualifications” for running the CDER, stated a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She is not versed in managing a large organization. She lacks background in industry regulation.”

Former commissioners of CBER would “be deeply familiar with laws and regulations and the underlying principles of medication creation”, said Dr. Janet Woodcock. “Frankly, she lacks the type of experience that previous people who headed CBER have had.”

The drug center has an enormous workload at the FDA, she emphasized.

“The public just zeroes in on the novel medication approvals, but the off-patent medication office approves a multitude of generic drugs. There’s a biologic copycat branch, OTC medication office and other areas, and each of these have to be supervised,” Dr. Woodcock noted. “The thing you don’t keep your eye on, that is precisely what that I always told people is going to come back to haunt you.”

There is also, a major leadership element to the job, which manages over 5,000 staff members. “It is a huge administrative position, if you execute it properly,” the former official concluded.

Response and Controversial Programs

Regarding questions about Høeg’s fitness for the role and whether this selection represents more teamwork among FDA leaders on immunizations, a press secretary responded that the “inquiries rely on incorrect presumptions”.

“This background matches the functions of her job,” the representative explained, pointing to the months Høeg spent advising the agency head on “medication safety and oversight research, including computational safety modeling and immunization monitoring”.

As acting director, Høeg inherits the agency head's controversial priority voucher program, a contentious rapid medication authorization process that apparently troubled her predecessors. “By what process are these drugs being chosen for this voucher program? Who makes the choices?” Dr. Howard said. “There’s a lot of secrecy occurring at the regulatory body right now.”

Overall, he remarked, “the agency looks to be trending towards laxer oversight of all drugs, with the exception of vaccines.”

Documented Past Work on Vaccines

Regarding immunizations, Høeg has a more documented, if problematic, history, some experts said. She authored a research paper using non-validated volunteer-provided data to estimate the incidence of heart inflammation following Covid immunization. She counseled the state of Florida surgeon general Dr. Joseph Ladapo, who reportedly have altered data to imply Covid vaccines are riskier than they are.

Included in her “policy goals” for the incoming federal leadership featured revising guidelines for new vaccines and halting “unnecessary” vaccines, she remarked post-election on a podcast. At the agency, Dr. Høeg has according to sources suggested barring adolescent males from getting Covid vaccinations.

“She is an all-around true believer who begins with her preconceived notions and tailors the evidence to fit the evidence in a highly misleading, fraudulent manner,” Howard said.

Gaining Influence and a “Campaign of Retribution”

Høeg aligned with other skeptics, {like|