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Given that the US undertakes unprecedented adjustments to its vaccine guidelines, an unexpected name has surfaced in a surprising turn: Høeg, a Danish American sports medicine doctor and epidemiologist who initially gained attention by casting doubt on Covid vaccines in the pandemic and has concentrated on alleged deaths after COVID-19 immunization in her recent time at the US Food and Drug Administration (FDA).

Planned Overhauls to Childhood Vaccine Program

Agency leaders planned to unveil major revisions to the childhood immunization program in December, bringing the US with the Danish immunization schedule, sources say – a significant shift that would put the US out of alignment with much of the global community with insufficient data for improved outcomes. The announcement has been pushed back until the coming year.

Rather than the top vaccines chief, Dr. Høeg is scheduled to present at the gathering. She was recently named acting director of the FDA’s drug evaluation center, the fifth person to lead the office this year.

A Shift at the FDA

The acting appointment may indicate a tighter collaboration between the drug and biologics centers as Høeg and Prasad consolidate power at the FDA – and it suggests a renewed priority upon rolling back already-approved immunizations at the FDA.

Dr. Høeg has often pushed for ending certain childhood immunization guidelines in the US in order to be more in line with Denmark, a nation with comprehensive healthcare and a citizenry roughly the size of Wisconsin’s.

To date comments, she has persisted in emphasizing on immunizations – traditionally the responsibility of Dr. Prasad, head of the FDA’s CBER – as opposed to pharmaceutical oversight.

Doubts Over Expertise

Dr. Høeg has little discernible background in drug development, regulation or leadership, which has been standard for former heads of the biologics center. She has worked at the FDA as a top consultant to the commissioner and CBER since March.

“She appears not to have any of the qualifications” for overseeing the pharmaceutical oversight division, stated Dr. Jonathan Howard. “She lacks experience running a randomized controlled trial. She has no expertise in running a sizeable institution. She has no expertise in pharmaceutical oversight.”

Former directors of CBER would “be deeply familiar with legal statutes and the science of pharmaceutical innovation”, commented Dr. Janet Woodcock. “Frankly, she doesn’t have the kind of background that prior appointees who headed CBER have had.”

This division has an vast workload at the FDA, she emphasized.

“The public just focuses on the innovative therapies, but the generic drug division authorizes thousands of generic medications. There is also a biologic copycat branch, non-prescription drug unit and other areas, and all of those need to be supervised,” Woodcock noted. “The thing you don’t keep your eye on, that is precisely what that I always told people is going to cause problems.”

Furthermore, a major leadership element to the role, which oversees more than 5,000 staff members. “It is a enormous leadership role, if you do it right,” the former official added.

Official Statement and Contentious Programs

When asked about questions about Høeg’s qualifications and whether this assignment signifies more teamwork among regulatory chiefs on vaccines, a press secretary said that the “concerns are based on incorrect premises”.

“Her experience aligns with the responsibilities of her position,” the representative stated, pointing to the time Høeg spent guiding the agency head on “drug safety and regulatory science, including computational safety modeling and vaccine surveillance”.

In her interim role, Høeg assumes responsibility for the commissioner’s new fast-track approval initiative, a contentious one-day therapy clearance system that allegedly concerned her predecessors. “How are these drugs being selected for this expedited pathway? Who takes the choices?” Dr. Howard said. “There is a lot of lack of transparency occurring at the agency right now.”

Broadly speaking, he remarked, “the Food and Drug Administration seems to be moving towards more relaxed rules of most medications, except for immunizations.”

Public History on Immunizations

With immunizations, Dr. Høeg has a clearer, if problematic, track record, some experts have noted. She authored a research paper using unconfirmed volunteer-provided data to assess the frequency of heart inflammation following Covid vaccination. She advised the state of Florida chief medical officer Dr. Joseph Ladapo, who allegedly have modified findings to indicate Covid vaccinations are more dangerous than they are.

Included in her “desired changes” for the current government featured changing regulations for novel immunizations and ending “optional” vaccines, she stated post-election on a audio program. At the FDA, Dr. Høeg has reportedly floated the idea of barring young men from obtaining Covid vaccines.

“She is an all-around true believer who commences with her conclusions and works backwards to retrofit the science in a very disingenuous, untruthful manner,” Dr. Howard said.

Consolidating Power and a “Push for Payback”

Dr. Høeg joined other contrarians, {like|