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As America proceeds with historic changes to its vaccine schedules, one figure appears in a surprising turn: Høeg, a Danish American sports medicine doctor and public health researcher who rose to prominence by expressing skepticism about coronavirus vaccinations during the pandemic and has zeroed in on alleged fatalities following Covid immunization in her short position at the Food and Drug Administration.

Planned Shifts to Childhood Immunization Schedule

Public health authorities had intended to unveil radical changes to the pediatric vaccine schedule recently, aligning the US with Denmark’s immunization schedule, it is understood – a substantial departure that would put the US out of step with much of the world with no evidence for benefit. The announcement has been postponed until the new year.

Instead of Vinay Prasad, Høeg is set to speak at the event. She was just designated acting director of the FDA’s drug evaluation center, the fifth appointee to lead the center this calendar year.

A Shift at the FDA

The acting appointment might represent a tighter collaboration between the pharmaceutical and vaccine divisions as Dr. Høeg and Dr. Prasad solidify control at the agency – and it signals a renewed priority upon reevaluating long-standing immunizations at the FDA.

Dr. Høeg has frequently advocated for halting some pediatric shot schedules in the US so as to align more like Denmark, a nation with nationalized medicine and a number of inhabitants roughly the size of the state of Wisconsin.

To date public appearances, she has kept her attention on immunizations – traditionally the domain of Dr. Prasad, director of the FDA’s vaccine center – rather than drug regulation.

Questions Over Background

The appointee has no apparent background in drug development, approval processes or leadership, which has been standard for previous directors of the Center for Biologics Evaluation and Research. She has been employed at the FDA as a top consultant to the commissioner and the vaccine center since March.

“She doesn’t seem to have the necessary background” for overseeing the pharmaceutical oversight division, stated a neurologist and psychiatrist. “She lacks experience running a clinical trial. She is not versed in managing a sizeable institution. She is not an expert in industry regulation.”

Past commissioners of CBER would “be deeply familiar with regulatory frameworks and the research of drug development”, said Dr. Janet Woodcock. “Objectively, she has not acquired the kind of background that previous people who led CBER have had.”

This division has an immense range of responsibilities at the agency, she stated.

“The public just zeroes in on the novel medication approvals, but the generic program approves a multitude of off-brand pharmaceuticals. There’s a biologic copycat branch, over-the-counter program and so forth, and all of those must be managed,” she said. “The responsibility you overlook, that’s the thing that I always told people is going to cause problems.”

Additionally, a major management element to the job, which supervises over 5,000 staff members. “It is a massive leadership role, if you perform it correctly,” the former official added.

Response and Contentious Initiatives

In response to questions about Dr. Høeg's fitness for the role and whether this assignment signifies more teamwork among FDA leaders on immunizations, a representative responded that the “questions are based on incorrect presumptions”.

“Her resume matches the responsibilities of her role,” the official stated, noting the time Dr. Høeg spent advising the FDA commissioner on “drug safety and approval science, including predictive safety algorithms and shot safety tracking”.

In her interim role, Høeg takes over the commissioner’s controversial priority voucher program, a disputed one-day therapy clearance system that apparently concerned her predecessors. “By what process are these therapies being chosen for this expedited pathway? Who takes the choices?” Dr. Howard asked. “There is a lot of confidentiality happening at the regulatory body right now.”

Overall, he stated, “the agency appears to be shifting towards more relaxed rules of all drugs, with the exception of immunizations.”

Established History on Immunizations

With immunizations, Dr. Høeg has a more documented, if concerning, track record, critics observe. She released a analysis using unconfirmed crowd-sourced reports to assess the rate of heart inflammation following Covid immunization. She consulted for the Florida surgeon general Joseph Ladapo, who allegedly have modified findings to suggest Covid vaccinations are more dangerous than they are.

Among her “wish list” for the new federal leadership featured altering regulations for new vaccines and discontinuing “non-essential” immunizations, she remarked after the election on a online show. At the FDA, Høeg has allegedly proposed barring teenage boys from receiving COVID-19 vaccinations.

“She is an all-around ideologue who begins with her preconceived notions and reverse-engineers to retrofit the evidence in a extremely disingenuous, untruthful way,” Howard said.

Taking Control and a “Push for Payback”

Høeg aligned with fellow dissenters, {like|