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Given that the US continues making sweeping revisions to its vaccine recommendations, one figure has surfaced in a surprising turn: Høeg, a Danish American sports physician and public health researcher who rose to prominence by casting doubt on coronavirus vaccines throughout the global health crisis and has concentrated on possible fatalities following COVID-19 vaccination in her brief position at the FDA.

Scheduled Shifts to Childhood Immunization Schedule

Public health authorities had intended to reveal major revisions to the pediatric vaccine schedule recently, aligning the US with Denmark’s immunization schedule, sources say – a significant shift that would put the US out of step with a large portion of the international standard with little proof for benefit. The announcement has been postponed until the next year.

Instead of Vinay Prasad, Dr. Høeg is set to speak at the gathering. She was recently named interim head of the FDA’s drug evaluation center, the fifth appointee to run the office this year.

Consolidating Power at the Regulatory Body

This interim role could signify a strengthened alliance between the drug and vaccine branches as Dr. Høeg and Prasad strengthen their influence at the FDA – and it suggests a greater focus upon rolling back already-approved vaccines at the FDA.

The new acting director has often pushed for halting specific childhood immunization guidelines in the US in order to be more like Denmark's approach, a nation with nationalized medicine and a citizenry roughly the size of Wisconsin’s.

So far statements, she has kept her attention on vaccines – usually the domain of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than pharmaceutical oversight.

Questions Over Expertise

Høeg has no obvious background in drug development, oversight or leadership, which has been standard for previous leaders of the Center for Biologics Evaluation and Research. She has worked at the FDA as a senior adviser to the commissioner and the vaccine center since March.

“She doesn’t seem to have the necessary background” for running the drug-regulation department, stated a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She is not versed in leading a large organization. She lacks background in pharmaceutical oversight.”

Past directors of the center would “grasp legal statutes and the underlying principles of drug development”, said Janet Woodcock. “Clearly, she lacks the kind of background that former directors who headed the center have had.”

The drug center has an immense workload at the FDA, the former commissioner stated.

“The public just pays attention on the new drug program, but the generic drug division clears thousands of off-brand pharmaceuticals. There is also a biosimilars division, over-the-counter program and so forth, and each of these need to be supervised,” she noted. “The responsibility you don’t keep your eye on, that is precisely what that I always told people is going to come back to haunt you.”

Additionally, a major management aspect to the position, which manages in excess of 5,000 personnel. “It is a huge leadership role, if you execute it properly,” the former official concluded.

Official Statement and Contentious Policies

In response to inquiries about Dr. Høeg's fitness for the role and whether this appointment signifies increased cooperation among FDA leaders on vaccines, a press secretary said that the “inquiries are based on inaccurate premises”.

“This background matches the responsibilities of her job,” the representative stated, noting the time Dr. Høeg spent counseling the agency head on “pharmaceutical safety and approval science, including computational safety modeling and immunization monitoring”.

As the temporary head, Høeg inherits the commissioner’s new expedited review system, a controversial one-day medication authorization process that reportedly troubled her former heads. “How are these therapies being picked for this voucher program? Who takes the choices?” Dr. Howard questioned. “There’s a lot of lack of transparency occurring at the regulatory body right now.”

Broadly speaking, he remarked, “the FDA looks to be trending towards more relaxed rules of most medications, aside from vaccines.”

Established Track Record on Vaccines

Regarding vaccines, Høeg has a clearer, if troubling, past, critics said. She released a study using unconfirmed volunteer-provided data to estimate the incidence of myocarditis following COVID-19 immunization. She consulted for the Florida top health official Dr. Joseph Ladapo, who allegedly have changed statistics to suggest COVID-19 vaccinations are pose a greater threat than they are.

Included in her “policy goals” for the incoming administration included revising regulations for novel immunizations and discontinuing “optional” immunizations, she remarked following the vote on a online show. At the FDA, Høeg has according to sources floated the idea of barring adolescent males from receiving COVID-19 vaccines.

“She’s an complete ideologue who begins with her conclusions and tailors the evidence to fit the evidence in a extremely disingenuous, fraudulent fashion,” Howard said.

Consolidating Power and a “Campaign of Retribution”

Høeg became part of other contrarians, {like|