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Given that the United States continues making unprecedented adjustments to its vaccine recommendations, one figure appears unexpectedly: Høeg, a US-based sports physician and public health researcher who first made her name by questioning COVID-19 vaccinations in the global health crisis and has zeroed in on alleged fatalities after COVID-19 vaccination in her brief time at the Food and Drug Administration.

Proposed Overhauls to Childhood Immunization Schedule

Agency leaders planned to unveil major revisions to the pediatric vaccination calendar earlier this month, synchronizing the US with the Danish immunization schedule, according to reports – a substantial departure that would place the US out of step with a large portion of the international standard with no evidence for improved outcomes. This reveal has been pushed back until the next year.

In place of the director of the vaccine center, Høeg is listed to address the audience at the event. She was newly appointed temporary leader of the FDA’s drug evaluation center, the fifth appointee to head the office this calendar year.

A Shift at the Agency

Høeg's temporary position may indicate a closer partnership between the drug and vaccine divisions as Høeg and Prasad solidify control at the agency – and it suggests a greater focus upon dismantling already-approved immunizations at the FDA.

The new acting director has repeatedly called for ending certain childhood vaccine recommendations in the US to become more like Denmark's approach, a country with universal health coverage and a population approximately the size of the state of Wisconsin.

So far public appearances, she has kept her attention on vaccines – usually the domain of Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than drug regulation.

Questions Over Background

Dr. Høeg has no obvious experience in pharmaceutical research, approval processes or leadership, which has been customary for former heads of the biologics center. She has served at the FDA as a key advisor to the agency head and the vaccine center since spring.

“She appears not to have any of the qualifications” for leading the pharmaceutical oversight division, remarked a neurologist and psychiatrist. “She’s never run a scientific study. She lacks experience in leading a large organization. She is not an expert in drug approvals.”

Former commissioners of the center would “understand legal statutes and the research of pharmaceutical innovation”, noted Janet Woodcock. “Objectively, she has not acquired the kind of background that prior appointees who headed the center have had.”

The drug center has an vast workload at the FDA, she pointed out.

“Everybody just zeroes in on the new drug program, but the off-patent medication office authorizes a multitude of off-brand pharmaceuticals. There’s a biosimilars program, over-the-counter program and other areas, and every single one must be managed,” she said. “The area you neglect, that is precisely what that I always told people is going to bite you.”

There is also, a substantial leadership element to the job, which supervises more than 5,000 personnel. “It is a huge leadership role, if you execute it properly,” the former official concluded.

Agency Reaction and Contentious Policies

When asked about inquiries about Dr. Høeg's fitness for the role and whether this assignment represents increased cooperation among FDA leaders on immunizations, a press secretary stated that the “inquiries stem from flawed premises”.

“This background matches the duties of her job,” the representative stated, noting the months Dr. Høeg spent counseling the FDA commissioner on “medication safety and approval science, including computerized risk analysis and immunization monitoring”.

As acting director, Høeg assumes responsibility for the agency head's recently launched fast-track approval initiative, a controversial one-day therapy clearance system that apparently concerned her preceding directors. “How are these medications being selected for this expedited pathway? Who takes the decisions?” Dr. Howard said. “There is a lot of lack of transparency happening at the FDA right now.”

Overall, he remarked, “the agency looks to be trending towards laxer rules of pharmaceuticals, except for immunizations.”

Public Past Work on Immunizations

With vaccines, Dr. Høeg has a more established, if problematic, past, some experts have noted. She published a research paper using unverified public submissions to determine the incidence of myocarditis following COVID-19 immunization. She advised the state of Florida surgeon general Dr. Joseph Ladapo, who was said to have modified findings to imply COVID-19 vaccinations are pose a greater threat than they are.

Part of her “policy goals” for the new administration featured changing rules for novel immunizations and ending “unnecessary” vaccines, she said following the vote on a podcast. At the FDA, Dr. Høeg has reportedly suggested excluding adolescent males from receiving COVID-19 vaccinations.

“She’s an thorough dogmatist who commences with her beliefs and works backwards to accommodate the evidence in a very misleading, untruthful fashion,” Howard said.

Consolidating Power and a “Revenge Tour”

Høeg joined fellow skeptics, {like|