🔗 Share this article

As America proceeds with sweeping revisions to its immunization guidelines, a particular individual appears unexpectedly: Høeg, a Danish American sports physician and public health researcher who initially gained attention by questioning COVID-19 shots in the pandemic and has focused upon alleged fatalities after COVID-19 vaccination in her recent tenure at the Food and Drug Administration.

Planned Overhauls to Childhood Immunization Schedule

Public health authorities had intended to unveil radical revisions to the pediatric vaccination calendar in December, aligning the US with Denmark’s national calendar, sources say – a major change that would put the US out of step with a large portion of the international standard with little proof for benefit. The planned update has been delayed until the new year.

In place of the top vaccines chief, Tracy Beth Høeg is set to address the audience at the event. She was recently named acting director of the FDA’s drug evaluation center, the fifth appointee to run the division this calendar year.

A Shift at the FDA

The acting appointment could signify a tighter collaboration between the pharmaceutical and biologics branches as Høeg and Prasad consolidate power at the FDA – and it suggests a greater focus upon rolling back previously authorized immunizations at the FDA.

Dr. Høeg has frequently advocated for halting certain childhood immunization guidelines in the US to become more in line with the Danish model, a nation with comprehensive healthcare and a citizenry approximately the size of Wisconsin’s.

In her initial public appearances, she has kept her attention on vaccination policy – usually the purview of Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of medication approval.

Doubts Over Background

Høeg has no obvious experience in pharmaceutical research, approval processes or administrative roles, which has been typical for former leaders of the biologics center. She has worked at the FDA as a top consultant to the agency head and the vaccine center since spring.

“She doesn’t seem to have the requisite experience” for running the CDER, stated a neurologist and psychiatrist. “She lacks experience running a randomized controlled trial. She lacks experience in leading a sizeable institution. She is not an expert in industry regulation.”

Previous heads of the center would “be deeply familiar with legal statutes and the underlying principles of medication creation”, said Janet Woodcock. “Clearly, she has not acquired the sort of resume that prior appointees who headed CBER have had.”

The drug center has an vast range of responsibilities at the FDA, she stated.

“Everybody just zeroes in on the novel medication approvals, but the generic drug division authorizes thousands of generic drugs. There’s a biosimilars program, OTC medication office and other areas, and each of these have to be looked after,” Woodcock noted. “The thing you don’t keep your eye on, that is the part that I always told people is going to come back to haunt you.”

Additionally, a significant leadership component to the position, which manages over 5,000 staff members. “It is a huge leadership role, if you do it right,” she concluded.

Agency Reaction and Contentious Policies

Regarding concerns about Dr. Høeg's credentials and whether this selection represents greater collaboration among agency officials on vaccines, a press secretary responded that the “inquiries rely on inaccurate assumptions”.

“This background matches the responsibilities of her position,” the spokesperson said, noting the time Høeg spent advising the FDA commissioner on “drug safety and regulatory science, including computational safety modeling and immunization monitoring”.

As the temporary head, Høeg assumes responsibility for the agency head's controversial fast-track approval initiative, a controversial rapid medication authorization process that reportedly worried her preceding directors. “How are these therapies being picked for this expedited pathway? Who makes the decisions?” Dr. Howard asked. “There is a lot of lack of transparency occurring at the agency right now.”

In general, he said, “the Food and Drug Administration appears to be shifting towards laxer rules of all drugs, with the exception of shots.”

Documented History on Immunizations

Concerning vaccines, Høeg has a more established, if problematic, past, Howard said. She published a study using non-validated public submissions to estimate the rate of myocarditis after COVID-19 immunization. She advised the state of Florida top health official Joseph Ladapo, who allegedly have changed statistics to imply COVID-19 vaccines are riskier than they are.

Included in her “wish list” for the current federal leadership encompassed revising guidelines for new vaccines and halting “non-essential” vaccines, she remarked post-election on a podcast. At the FDA, Dr. Høeg has reportedly floated the idea of excluding young men from getting Covid vaccines.

“She is an complete ideologue who starts off with her preconceived notions and reverse-engineers to retrofit the science in a extremely disingenuous, fraudulent way,” Dr. Howard said.

Taking Control and a “Revenge Tour”

Dr. Høeg joined fellow skeptics, {like|