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While the United States continues making sweeping revisions to its vaccination recommendations, an unexpected name has emerged somewhat surprisingly: Høeg, a US-based physician and epidemiologist who rose to prominence by casting doubt on COVID-19 vaccines during the pandemic and has concentrated on alleged fatalities after Covid vaccination in her recent position at the FDA.

Planned Shifts to Pediatric Vaccine Program

Public health authorities were set to announce major changes to the pediatric vaccine schedule earlier this month, aligning the US with the Danish national calendar, sources say – a significant shift that would put the US out of step with much of the global community with insufficient data for improved outcomes. This reveal has been delayed until the next year.

In place of the director of the vaccine center, Høeg is listed to present at the gathering. She was newly appointed acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to run the office this calendar year.

Consolidating Power at the Agency

The acting appointment might represent a tighter collaboration between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad strengthen their influence at the agency – and it suggests a renewed priority upon dismantling previously authorized immunizations at the FDA.

The new acting director has frequently advocated for ending certain childhood immunization guidelines in the US in order to be more similar to the Danish model, a society with comprehensive healthcare and a population approximately the size of Wisconsin’s.

To date public appearances, she has persisted in emphasizing on immunizations – typically the purview of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than pharmaceutical oversight.

Concerns Over Qualifications

Dr. Høeg has no apparent experience in drug development, regulation or administrative roles, which has been typical for former leaders of the biologics center. She has been employed at the FDA as a senior adviser to the agency head and CBER since earlier this year.

“She doesn’t seem to have the requisite experience” for leading the drug-regulation department, said a neurologist and psychiatrist. “She lacks experience running a randomized controlled trial. She has no expertise in leading a large organization. She is not an expert in industry regulation.”

Past commissioners of CBER would “understand legal statutes and the underlying principles of medication creation”, noted Dr. Janet Woodcock. “Frankly, she has not acquired the kind of background that former directors who ran CBER have had.”

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

“Everybody just focuses on the novel medication approvals, but the off-patent medication office authorizes thousands of off-brand pharmaceuticals. There’s a biosimilars division, over-the-counter program and other areas, and every single one have to be supervised,” Dr. Woodcock said. “The area you don’t keep your eye on, that is precisely what that I always told people is going to bite you.”

There is also, a major leadership element to the role, which oversees more than 5,000 employees. “It’s a huge management job, if you perform it correctly,” Woodcock added.

Response and Controversial Programs

Regarding concerns about Dr. Høeg's qualifications and whether this selection represents more teamwork among FDA leaders on vaccines, a representative said that the “concerns are based on incorrect premises”.

“Her experience aligns with the responsibilities of her role,” the spokesperson said, pointing to the months Dr. Høeg spent advising the FDA commissioner on “medication safety and approval science, including computerized risk analysis and shot safety tracking”.

In her interim role, Dr. Høeg inherits the agency head's new priority voucher program, a contentious one-day therapy clearance system that apparently troubled her predecessors. “By what process are these therapies being selected for this fast-track system? Who takes the calls?” Howard questioned. “There’s a lot of lack of transparency occurring at the agency right now.”

Broadly speaking, he said, “the Food and Drug Administration looks to be trending towards laxer rules of most medications, aside from immunizations.”

Documented Track Record on Immunizations

Regarding vaccines, Dr. Høeg has a clearer, if problematic, past, Howard said. She published a analysis using non-validated public submissions to determine the incidence of heart inflammation after COVID-19 immunization. She advised the state of Florida surgeon general Joseph Ladapo, who was said to have modified findings to suggest Covid vaccines are more dangerous than they are.

Part of her “policy goals” for the incoming administration encompassed changing guidelines for recently developed shots and ending “non-essential” immunizations, she remarked after the election on a online show. At the agency, Dr. Høeg has reportedly floated the idea of preventing young men from getting Covid vaccinations.

“She is an thorough true believer who commences with her preconceived notions and works backwards to fit the data in a very deceptive, dishonest fashion,” Howard stated.

Taking Control and a “Campaign of Retribution”

Høeg joined fellow skeptics, {like|