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While the US continues making unprecedented changes to its immunization guidelines, one figure appears in a surprising turn: Høeg, an American of Danish descent physician and epidemiologist who initially gained attention by questioning Covid vaccinations throughout the global health crisis and has concentrated on alleged deaths after COVID-19 vaccination in her recent tenure at the US Food and Drug Administration (FDA).

Planned Changes to Pediatric Immunization Program

Public health authorities had intended to announce major changes to the childhood vaccine schedule in December, bringing the US with the Danish national calendar, sources say – a significant shift that would place the US out of step with a large portion of the global community with no evidence for public health gain. This reveal has been pushed back until the new year.

Instead of the director of the vaccine center, Dr. Høeg is scheduled to address the audience at the meeting. She was just designated acting director of the FDA’s CDER, the fifth person to run the office this year.

Consolidating Power at the FDA

The acting appointment could signify a closer partnership between the drug and vaccine centers as Høeg and Prasad solidify control at the regulatory agency – and it points to a renewed priority upon rolling back previously authorized immunizations at the FDA.

The new acting director has frequently advocated for halting some childhood vaccine recommendations in the US so as to align more in line with Denmark, a nation with universal health coverage and a number of inhabitants approximately the size of the state of Wisconsin.

To date statements, she has kept her attention on immunizations – traditionally the responsibility of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than pharmaceutical oversight.

Concerns Over Background

Høeg has little discernible track record in medication creation, regulation or management, which has been customary for previous directors of the biologics center. She has worked at the FDA as a key advisor to the commissioner and the vaccine center since spring.

“She appears not to have the necessary background” for running the CDER, remarked Dr. Jonathan Howard. “She lacks experience running a scientific study. She has no expertise in running a sizeable institution. She lacks background in pharmaceutical oversight.”

Past commissioners of the center would “grasp laws and regulations and the research of drug development”, commented a former acting FDA commissioner. “Clearly, she lacks the kind of background that previous people who ran CBER have had.”

The drug center has an vast range of responsibilities at the agency, the former commissioner emphasized.

“The public just zeroes in on the new drug program, but the generic drug division clears a multitude of generic drugs. There’s a biosimilars program, non-prescription drug unit and so forth, and all of those have to be looked after,” Dr. Woodcock noted. “The area you overlook, that’s the thing that I always told people is going to bite you.”

Furthermore, a major leadership component to the job, which manages over 5,000 employees. “It’s a enormous management job, if you execute it properly,” the former official concluded.

Agency Reaction and Disputed Programs

In response to inquiries about Høeg’s credentials and whether this assignment represents increased cooperation among FDA leaders on vaccines, a press secretary stated that the “questions stem from flawed assumptions”.

“Her resume aligns with the duties of her role,” the representative explained, citing the time Dr. Høeg spent counseling the FDA commissioner on “pharmaceutical safety and approval science, including computational safety modeling and shot safety tracking”.

In her interim role, Dr. Høeg inherits the agency head's new priority voucher program, a controversial expedited therapy clearance system that apparently concerned her former heads. “By what process are these medications being chosen for this voucher program? Who is making the calls?” Howard asked. “There’s a lot of lack of transparency going on at the agency right now.”

Broadly speaking, he remarked, “the Food and Drug Administration seems to be moving towards laxer rules of all drugs, with the exception of immunizations.”

Established Track Record on Immunizations

Concerning vaccines, Høeg has a more documented, if concerning, past, critics said. She authored a study using non-validated volunteer-provided data to estimate the incidence of heart inflammation following Covid vaccination. She counseled the Florida chief medical officer Dr. Joseph Ladapo, who allegedly have altered data to imply Covid vaccinations are pose a greater threat than they are.

Among her “desired changes” for the new government featured altering guidelines for recently developed shots and ending “non-essential” vaccines, she said following the vote on a podcast. At the FDA, Høeg has reportedly proposed preventing teenage boys from obtaining Covid vaccines.

“She’s an thorough dogmatist who begins with her beliefs and works backwards to retrofit the data in a highly deceptive, untruthful manner,” Dr. Howard stated.

Taking Control and a “Push for Payback”

Dr. Høeg became part of other contrarians, {like|