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Given that the United States undertakes unprecedented changes to its vaccine schedules, one figure appears unexpectedly: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by questioning coronavirus shots throughout the global health crisis and has focused upon potential deaths after COVID-19 immunization in her short time at the Food and Drug Administration.

Planned Changes to Pediatric Vaccine Schedule

Public health authorities planned to unveil sweeping revisions to the pediatric vaccination calendar recently, bringing the US with the Danish national calendar, sources say – a substantial departure that would place the US out of alignment with much of the world with insufficient data for improved outcomes. The announcement has been postponed until the new year.

In place of the director of the vaccine center, Høeg is scheduled to present at the event. She was recently named acting director of the FDA’s CDER, the fifth individual to run the center this calendar year.

A New Direction at the Agency

The acting appointment may indicate a closer partnership between the drug and biologics centers as Høeg and Prasad strengthen their influence at the agency – and it points to a renewed priority upon dismantling long-standing immunizations at the FDA.

Høeg has frequently advocated for halting certain pediatric vaccine recommendations in the US so as to align more like Denmark's approach, a nation with universal health coverage and a population about the size of the state of Wisconsin.

So far statements, she has kept her attention on vaccines – usually the responsibility of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than pharmaceutical oversight.

Concerns Over Expertise

The appointee has little discernible track record in pharmaceutical research, approval processes or leadership, which has been standard for previous heads of the Center for Biologics Evaluation and Research. She has served at the FDA as a key advisor to the agency head and the vaccine center since March.

“She appears not to have the requisite experience” for leading the drug-regulation department, remarked a neurologist and psychiatrist. “She’s never run a scientific study. She is not versed in leading a major agency. She has no expertise in industry regulation.”

Former directors of CBER would “understand legal statutes and the underlying principles of medication creation”, commented a former acting FDA commissioner. “Objectively, she doesn’t have the sort of resume that previous people who ran the center have had.”

This division has an enormous range of responsibilities at the FDA, she pointed out.

“Everybody just pays attention on the innovative therapies, but the generic drug division authorizes numerous generic drugs. There’s a biologic copycat branch, OTC medication office and so forth, and each of these need to be managed,” she explained. “The area you don’t keep your eye on, that’s the thing that I always told people is going to bite you.”

Furthermore, a significant management element to the role, which supervises in excess of 5,000 employees. “It’s a massive administrative position, if you execute it properly,” she concluded.

Agency Reaction and Disputed Initiatives

Regarding concerns about Dr. Høeg's fitness for the role and whether this appointment signifies increased cooperation among regulatory chiefs on immunizations, a representative said that the “inquiries are based on incorrect assumptions”.

“Her experience aligns with the duties of her role,” the official explained, noting the period Dr. Høeg spent guiding the FDA commissioner on “medication safety and regulatory science, including computerized risk analysis and immunization monitoring”.

In her interim role, Dr. Høeg takes over the agency head's recently launched expedited review system, a controversial one-day therapy clearance system that allegedly troubled her preceding directors. “By what process are these medications being chosen for this expedited pathway? Who is making the choices?” Dr. Howard questioned. “There is a lot of lack of transparency happening at the regulatory body right now.”

Broadly speaking, he said, “the agency seems to be moving towards less stringent regulations of most medications, except for immunizations.”

Established Past Work on Vaccines

Concerning immunizations, Høeg has a more established, if troubling, past, critics observe. She released a study using non-validated public submissions to determine the rate of heart inflammation following Covid immunization. She counseled the Florida chief medical officer Dr. Joseph Ladapo, who was said to have altered data to indicate COVID-19 vaccinations are pose a greater threat than they are.

Part of her “policy goals” for the new government included revising guidelines for new vaccines and discontinuing “optional” vaccines, she stated post-election on a audio program. At the FDA, Dr. Høeg has according to sources floated the idea of preventing teenage boys from obtaining Covid vaccines.

“She is an all-around dogmatist who begins with her preconceived notions and works backwards to accommodate the evidence in a extremely disingenuous, fraudulent fashion,” Howard said.

Gaining Influence and a “Push for Payback”

Dr. Høeg joined other dissenters, {like|