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While the US continues making sweeping revisions to its immunization schedules, an unexpected name has emerged somewhat surprisingly: Høeg, an American of Danish descent sports medicine doctor and epidemiologist who first made her name by casting doubt on Covid vaccinations during the global health crisis and has focused upon alleged fatalities following Covid vaccination in her recent time at the FDA.

Proposed Shifts to Childhood Immunization Program

Agency leaders had intended to unveil major revisions to the childhood vaccination calendar in December, aligning the US with the Danish national calendar, according to reports – a substantial departure that would place the US out of alignment with many the global community with little proof for benefit. The announcement has been delayed until the coming year.

Instead of the top vaccines chief, Høeg is scheduled to present at the gathering. She was recently named interim head of the FDA’s CDER, the fifth individual to lead the center this calendar year.

Consolidating Power at the FDA

This interim role may indicate a strengthened alliance between the drug and biologics branches as Høeg and Prasad consolidate power at the FDA – and it points to a renewed priority upon rolling back previously authorized immunizations at the FDA.

The new acting director has repeatedly called for discontinuing certain pediatric vaccine recommendations in the US so as to align more similar to the Danish model, a country with universal health coverage and a citizenry approximately the population of the state of Wisconsin.

In her initial public appearances, she has continued to focus on vaccination policy – usually the domain of Dr. Prasad, head of the FDA’s vaccine center – instead of drug regulation.

Doubts Over Background

Høeg has no obvious background in pharmaceutical research, approval processes or management, which has been typical for past directors of the CBER. She has served at the FDA as a top consultant to the commissioner 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 clinical trial. She lacks experience in running a major agency. She lacks background in industry regulation.”

Previous heads of CBER would “grasp legal statutes and the science of drug development”, said Janet Woodcock. “Frankly, she doesn’t have the type of experience that former directors who headed the center have had.”

The drug center has an immense portfolio at the FDA, she pointed out.

“Everybody just pays attention on the novel medication approvals, but the off-patent medication office approves a multitude of generic drugs. There’s a biosimilars program, non-prescription drug unit and other areas, and all of those must be supervised,” she explained. “The thing you overlook, that is the part that I always told people is going to come back to haunt you.”

There is also, a major administrative element to the job, which supervises more than 5,000 employees. “It’s a huge leadership role, if you execute it properly,” she concluded.

Agency Reaction and Disputed Programs

Regarding concerns about Høeg’s qualifications and whether this appointment signifies greater collaboration among agency officials on immunizations, a representative responded that the “concerns stem from incorrect premises”.

“Her experience is consistent with the functions of her job,” the representative said, pointing to the period Dr. Høeg spent guiding the FDA commissioner on “pharmaceutical safety and oversight research, including computational safety modeling and immunization monitoring”.

As acting director, Dr. Høeg takes over the commissioner’s new expedited review system, a contentious one-day drug-approval program that allegedly worried her predecessors. “How are these medications being selected for this expedited pathway? Who makes the choices?” Howard questioned. “There’s a lot of confidentiality occurring at the regulatory body right now.”

Broadly speaking, he said, “the Food and Drug Administration appears to be shifting towards less stringent rules of all drugs, with the exception of shots.”

Public Past Work on Vaccines

Concerning immunizations, Høeg has a clearer, if problematic, past, critics said. She published a research paper using unconfirmed volunteer-provided data to assess the frequency of myocarditis following COVID-19 vaccination. She consulted for the Florida surgeon general Joseph Ladapo, who reportedly have modified findings to suggest Covid vaccinations are riskier than they are.

Included in her “wish list” for the incoming administration included changing guidelines for recently developed shots and halting “optional” immunizations, she remarked following the vote on a podcast. At the agency, Dr. Høeg has allegedly floated the idea of preventing teenage boys from getting Covid vaccinations.

“She’s an thorough dogmatist who starts off with her conclusions and tailors the evidence to accommodate the evidence in a extremely disingenuous, fraudulent way,” Howard stated.

Gaining Influence and a “Revenge Tour”

Dr. Høeg joined other skeptics, {like|