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As the United States continues making historic adjustments to its vaccination schedules, an unexpected name appears in a surprising turn: Høeg, a Danish American sports medicine doctor and public health researcher who initially gained attention by casting doubt on Covid vaccines in the global health crisis and has concentrated on alleged deaths after COVID-19 immunization in her recent time at the Food and Drug Administration.

Planned Changes to Childhood Vaccine Program

Public health authorities had intended to announce sweeping changes to the childhood vaccination calendar earlier this month, synchronizing the US with Denmark’s immunization schedule, according to reports – a significant shift that would put the US at odds with a large portion of the international standard with no evidence for public health gain. The announcement has been pushed back until the coming year.

Rather than Vinay Prasad, Høeg is scheduled to present at the event. She was newly appointed interim head of the FDA’s drug evaluation center, the fifth individual to run the office this year.

A New Direction at the Agency

The acting appointment might represent a tighter collaboration between the drug and vaccine divisions as Høeg and Dr. Prasad strengthen their influence at the agency – and it points to a increased emphasis upon reevaluating previously authorized immunizations at the FDA.

The new acting director has repeatedly called for discontinuing specific pediatric shot schedules in the US to become more like the Danish model, a society with nationalized medicine and a population roughly the population of the state of Wisconsin.

To date comments, she has kept her attention on vaccines – typically the domain of Dr. Prasad, chief of the FDA’s vaccine center – instead of medication approval.

Concerns Over Background

Høeg has no obvious background in pharmaceutical research, regulation or leadership, which has been typical for former directors of the Center for Biologics Evaluation and Research. She has worked at the FDA as a key advisor to the commissioner and CBER since earlier this year.

“She doesn’t seem to have the necessary background” for leading the pharmaceutical oversight division, said Jonathan Howard. “She has not conducted a clinical trial. She is not versed in managing a major agency. She has no expertise in drug approvals.”

Former commissioners of CBER would “be deeply familiar with laws and regulations and the science of drug development”, said Dr. Janet Woodcock. “Objectively, she doesn’t have the sort of resume that former directors who headed CBER have had.”

This division has an enormous range of responsibilities at the agency, Woodcock pointed out.

“Everybody just focuses on the innovative therapies, but the generic program authorizes a multitude of off-brand pharmaceuticals. There is also a biologic copycat branch, over-the-counter program and other areas, and all of those must be supervised,” she explained. “The area you overlook, that is the part that I always told people is going to come back to haunt you.”

Furthermore, a significant administrative component to the role, which supervises in excess of 5,000 personnel. “It’s a massive administrative position, if you do it right,” the former official concluded.

Official Statement and Contentious Programs

In response to concerns about Dr. Høeg's fitness for the role and whether this appointment indicates increased cooperation among regulatory chiefs on vaccines, a representative responded that the “inquiries stem from incorrect presumptions”.

“Her resume is consistent with the duties of her job,” the representative explained, noting the months Høeg spent advising the agency head on “medication safety and regulatory science, including computational safety modeling and immunization monitoring”.

As acting director, Høeg assumes responsibility for the agency head's new expedited review system, a disputed rapid drug-approval program that apparently worried her predecessors. “How are these medications being picked for this expedited pathway? Who makes the choices?” Dr. Howard said. “There is a lot of secrecy happening at the FDA right now.”

Broadly speaking, he stated, “the agency looks to be trending towards more relaxed oversight of pharmaceuticals, with the exception of shots.”

Established Track Record on Immunizations

Regarding vaccines, Dr. Høeg has a more established, if troubling, history, Howard have noted. She published a research paper using unverified volunteer-provided data to assess the incidence of heart inflammation after COVID-19 immunization. She consulted for the Florida top health official Dr. Joseph Ladapo, who reportedly have changed statistics to suggest Covid vaccinations are more dangerous than they are.

Part of her “policy goals” for the new administration featured altering guidelines for new vaccines and discontinuing “non-essential” immunizations, she stated post-election on a online show. At the FDA, Dr. Høeg has allegedly floated the idea of excluding adolescent males from receiving COVID-19 vaccinations.

“She’s an all-around ideologue who commences with her beliefs and works backwards to retrofit the science in a highly misleading, dishonest fashion,” Dr. Howard argued.

Consolidating Power and a “Revenge Tour”

Høeg became part of fellow skeptics, {like|