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Given that the United States continues making unprecedented changes to its immunization guidelines, one figure appears somewhat surprisingly: Høeg, a Danish American sports medicine doctor and public health researcher who first made her name by expressing skepticism about COVID-19 shots throughout the pandemic and has focused upon possible fatalities after COVID-19 immunization in her brief time at the Food and Drug Administration.

Proposed Shifts to Pediatric Vaccine Schedule

Agency leaders planned to unveil sweeping changes to the childhood immunization program recently, aligning the US with Denmark’s immunization schedule, according to reports – a significant shift that would place the US out of alignment with a large portion of the global community with no evidence for public health gain. This reveal has been pushed back until the next year.

Instead of the director of the vaccine center, Høeg is scheduled to present at the meeting. She was recently named interim head of the FDA’s CDER, the fifth appointee to run the office this calendar year.

A Shift at the FDA

This interim role might represent a tighter collaboration between the pharmaceutical and vaccine divisions as Dr. Høeg and Dr. Prasad strengthen their influence at the regulatory agency – and it suggests a greater focus upon dismantling long-standing immunizations at the FDA.

Høeg has repeatedly called for halting some childhood immunization guidelines in the US in order to be more like the Danish model, a nation with universal health coverage and a number of inhabitants roughly the population of Wisconsin’s.

In her initial public appearances, she has kept her attention on vaccination policy – traditionally the domain of Dr. Prasad, chief of the FDA’s CBER – instead of drug regulation.

Concerns Over Expertise

Dr. Høeg has little discernible experience in drug development, approval processes or administrative roles, which has been typical for former leaders of the CBER. She has served at the FDA as a senior adviser to the FDA chief and CBER since March.

“She appears not to have any of the qualifications” for overseeing the CDER, remarked Dr. Jonathan Howard. “She lacks experience running a scientific study. She lacks experience in running a large organization. She lacks background in industry regulation.”

Past heads of the center would “understand laws and regulations and the underlying principles of pharmaceutical innovation”, commented a former acting FDA commissioner. “Objectively, she has not acquired the sort of resume that prior appointees who ran CBER have had.”

The drug center has an enormous portfolio at the agency, she stated.

“Everybody just pays attention on the novel medication approvals, but the off-patent medication office clears numerous generic medications. There is also a biosimilars program, non-prescription drug unit and more, and every single one have to be looked after,” she noted. “The thing you neglect, that is the part that I always told people is going to cause problems.”

Additionally, a major management component to the job, which manages over 5,000 employees. “It’s a enormous leadership role, if you execute it properly,” she said.

Agency Reaction and Contentious Policies

Regarding concerns about Dr. Høeg's credentials and whether this appointment indicates increased cooperation among regulatory chiefs on immunizations, a representative said that the “questions stem from flawed premises”.

“Her resume aligns with the functions of her position,” the official explained, pointing to the period Dr. Høeg spent guiding the agency head on “drug safety and regulatory science, including predictive safety algorithms and vaccine surveillance”.

As the temporary head, Dr. Høeg inherits the commissioner’s new expedited review system, a controversial expedited therapy clearance system that apparently concerned her former heads. “By what process are these medications being chosen for this fast-track system? Who takes the choices?” Dr. Howard questioned. “There’s a lot of lack of transparency occurring at the FDA right now.”

Overall, he said, “the Food and Drug Administration looks to be trending towards laxer oversight of pharmaceuticals, aside from immunizations.”

Documented History on Vaccines

Concerning vaccines, Dr. Høeg has a more established, if troubling, past, some experts said. She authored a research paper using unverified volunteer-provided data to estimate the incidence of heart inflammation after COVID-19 vaccination. She counseled the state of Florida top health official Dr. Joseph Ladapo, who was said to have altered data to suggest COVID-19 vaccines are riskier than they are.

Part of her “policy goals” for the new government encompassed changing guidelines for novel immunizations and ending “optional” vaccines, she remarked following the vote on a online show. At the agency, Dr. Høeg has reportedly proposed preventing teenage boys from receiving COVID-19 vaccines.

“She’s an thorough dogmatist who begins with her beliefs and works backwards to fit the evidence in a very deceptive, fraudulent fashion,” Howard stated.

Gaining Influence and a “Push for Payback”

Dr. Høeg aligned with fellow dissenters, {like|