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While America proceeds with historic revisions to its vaccination recommendations, an unexpected name has emerged somewhat surprisingly: Høeg, an American of Danish descent physician and public health researcher who initially gained attention by expressing skepticism about coronavirus vaccines throughout the global health crisis and has focused upon alleged fatalities after Covid vaccination in her brief tenure at the Food and Drug Administration.

Scheduled Changes to Childhood Vaccine Program

Health officials planned to announce radical changes to the childhood vaccine schedule in December, aligning the US with Denmark’s immunization schedule, sources say – a major change that would put the US out of step with a large portion of the international standard with insufficient data for improved outcomes. This reveal has been postponed until the next year.

Instead of Vinay Prasad, Dr. Høeg is listed to present at the gathering. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to head the center this year.

A New Direction at the Agency

The acting appointment might represent a closer partnership between the drug and vaccine centers as Høeg and Dr. Prasad strengthen their influence at the agency – and it points to a increased emphasis upon dismantling already-approved immunizations at the FDA.

The new acting director has frequently advocated for halting certain childhood immunization guidelines in the US in order to be more like Denmark's approach, a society with nationalized medicine and a population approximately the size of the state of Wisconsin.

So far statements, she has continued to focus on immunizations – traditionally the domain of Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of pharmaceutical oversight.

Doubts Over Background

The appointee has no apparent background in pharmaceutical research, approval processes or management, which has been customary for past heads of the CBER. She has been employed at the FDA as a key advisor to the agency head and the vaccine center since earlier this year.

“It seems she lacks to have any of the qualifications” for running the pharmaceutical oversight division, said Dr. Jonathan Howard. “She’s never run a randomized controlled trial. She has no expertise in managing a large organization. She lacks background in drug approvals.”

Former heads of the center would “be deeply familiar with regulatory frameworks and the research of drug development”, commented Janet Woodcock. “Frankly, she lacks the kind of background that previous people who ran the center have had.”

This division has an vast range of responsibilities at the FDA, Woodcock stated.

“The public just pays attention on the innovative therapies, but the generic program authorizes numerous generic medications. There’s a biologic copycat branch, over-the-counter program and so forth, and every single one need to be looked after,” she explained. “The thing you don’t keep your eye on, that’s the thing that I always told people is going to cause problems.”

Furthermore, a major management element to the job, which manages more than 5,000 employees. “It is a massive leadership role, if you execute it properly,” she added.

Agency Reaction and Contentious Programs

When asked about concerns about Høeg’s credentials and whether this appointment signifies more teamwork among FDA leaders on immunizations, a press secretary stated that the “questions rely on flawed premises”.

“This background is consistent with the functions of her role,” the official stated, pointing to the time Høeg spent guiding the FDA commissioner on “medication safety and regulatory science, including computational safety modeling and vaccine surveillance”.

As the temporary head, Dr. Høeg assumes responsibility for the commissioner’s new expedited review system, a disputed rapid therapy clearance system that reportedly troubled her predecessors. “By what process are these drugs being chosen for this expedited pathway? Who is making the decisions?” Howard said. “There is a lot of lack of transparency happening at the FDA right now.”

Overall, he remarked, “the agency appears to be shifting towards laxer regulations of all drugs, with the exception of immunizations.”

Established Track Record on Immunizations

Regarding immunizations, Høeg has a more established, if concerning, past, critics said. She published a research paper using non-validated volunteer-provided data to estimate the incidence of myocarditis after Covid vaccination. She consulted for the Florida top health official Joseph Ladapo, who was said to have changed statistics to imply COVID-19 vaccines are more dangerous than they are.

Part of her “desired changes” for the new government included revising regulations for recently developed shots and halting “optional” immunizations, she said following the vote on a podcast. At the agency, Høeg has according to sources floated the idea of excluding young men from receiving Covid vaccinations.

“She’s an all-around dogmatist who begins with her beliefs and reverse-engineers to retrofit the science in a very disingenuous, dishonest fashion,” Howard said.

Taking Control and a “Campaign of Retribution”

Dr. Høeg aligned with fellow dissenters, {like|