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Given that the US proceeds with unprecedented revisions to its vaccine schedules, one figure has surfaced in a surprising turn: Høeg, a Danish American sports physician and epidemiologist who first made her name by expressing skepticism about Covid vaccines in the pandemic and has concentrated on alleged fatalities following COVID-19 immunization in her recent position at the Food and Drug Administration.

Scheduled Shifts to Pediatric Immunization Program

Agency leaders were set to announce sweeping changes to the pediatric immunization program recently, aligning the US with Denmark’s vaccine program, according to reports – a major change that would put the US at odds with many the world with insufficient data for benefit. The planned update has been postponed until the next year.

Instead of Vinay Prasad, Høeg is scheduled to address the audience at the meeting. She was newly appointed interim head of the FDA’s drug evaluation center, the fifth person to run the office this year.

A Shift at the Agency

Høeg's temporary position may indicate a tighter collaboration between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad solidify control at the agency – and it signals a renewed priority upon rolling back already-approved immunizations at the FDA.

Dr. Høeg has often pushed for ending some pediatric immunization guidelines in the US so as to align more similar to Denmark, a country with comprehensive healthcare and a citizenry approximately the population of the state of Wisconsin.

To date comments, she has persisted in emphasizing on immunizations – traditionally the responsibility of Prasad, director of the FDA’s CBER – as opposed to pharmaceutical oversight.

Concerns Over Expertise

Dr. Høeg has no obvious experience in medication creation, approval processes or administrative roles, which has been customary for previous leaders of the CBER. She has worked at the FDA as a top consultant to the FDA chief and CBER since spring.

“She doesn’t seem to have any of the qualifications” for leading the drug-regulation department, stated a neurologist and psychiatrist. “She’s never run a scientific study. She is not versed in running a sizeable institution. She is not an expert in drug approvals.”

Past directors of the center would “understand regulatory frameworks and the science of drug development”, noted Janet Woodcock. “Frankly, she doesn’t have the kind of background that former directors who headed the center have had.”

CDER has an vast portfolio at the agency, she emphasized.

“Many people just zeroes in on the novel medication approvals, but the off-patent medication office clears thousands of off-brand pharmaceuticals. There is also a biosimilars program, over-the-counter program and so forth, and all of those have to be supervised,” she explained. “The thing you neglect, that’s the thing that I always told people is going to come back to haunt you.”

Additionally, a major administrative aspect to the position, which oversees over 5,000 staff members. “It’s a huge management job, if you execute it properly,” she added.

Response and Controversial Initiatives

When asked about questions about Høeg’s credentials and whether this selection represents increased cooperation among regulatory chiefs on immunizations, a spokesperson said that the “concerns rely on incorrect presumptions”.

“Her experience matches the functions of her role,” the representative explained, pointing to the period Høeg spent counseling the FDA commissioner on “pharmaceutical safety and approval science, including computerized risk analysis and immunization monitoring”.

As the temporary head, Dr. Høeg assumes responsibility for the commissioner’s new expedited review system, a contentious expedited therapy clearance system that apparently concerned her predecessors. “How are these therapies being picked for this voucher program? Who takes the calls?” Dr. Howard said. “There is a lot of lack of transparency happening at the regulatory body right now.”

In general, he stated, “the agency looks to be trending towards less stringent oversight of all drugs, with the exception of vaccines.”

Public Track Record on Vaccines

With immunizations, Dr. Høeg has a clearer, if problematic, history, some experts said. She published a study using non-validated volunteer-provided data to estimate the rate of myocarditis following COVID-19 vaccination. She advised the Florida chief medical officer Joseph Ladapo, who was said to have altered data to suggest Covid vaccinations are pose a greater threat than they are.

Included in her “wish list” for the current administration encompassed changing guidelines for new vaccines and halting “unnecessary” immunizations, she said after the election on a podcast. At the FDA, Dr. Høeg has allegedly floated the idea of excluding teenage boys from receiving COVID-19 vaccines.

“She’s an thorough ideologue who commences with her preconceived notions and works backwards to accommodate the data in a extremely disingenuous, untruthful way,” Howard stated.

Taking Control and a “Revenge Tour”

Dr. Høeg joined other skeptics, {like|