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Given that the US undertakes sweeping adjustments to its vaccination guidelines, a particular individual appears unexpectedly: Høeg, a US-based physician and public health researcher who initially gained attention by questioning coronavirus shots in the pandemic and has zeroed in on alleged fatalities after COVID-19 vaccination in her brief position at the US Food and Drug Administration (FDA).

Planned Shifts to Pediatric Immunization Schedule

Health officials had intended to announce sweeping changes to the childhood vaccination calendar in December, synchronizing the US with Denmark’s vaccine program, it is understood – a major change that would place the US at odds with a large portion of the global community with no evidence for benefit. This reveal has been postponed until the next year.

Instead of Vinay Prasad, Høeg is scheduled to address the audience at the gathering. She was just designated interim head of the FDA’s drug evaluation center, the fifth person to head the center 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 Prasad strengthen their influence at the agency – and it signals a greater focus upon reevaluating previously authorized immunizations at the FDA.

Dr. Høeg has often pushed for discontinuing some childhood shot schedules in the US to become more like Denmark's approach, a nation with nationalized medicine and a population roughly the size of the state of Wisconsin.

So far public appearances, she has continued to focus on vaccination policy – traditionally the responsibility of Prasad, head of the FDA’s vaccine center – as opposed to drug regulation.

Questions Over Expertise

Høeg has little discernible track record in medication creation, approval processes or leadership, which has been customary for previous leaders of the CBER. She has been employed at the FDA as a top consultant to the FDA chief and CBER since March.

“She doesn’t seem to have the necessary background” for leading the pharmaceutical oversight division, remarked a neurologist and psychiatrist. “She’s never run a scientific study. She is not versed in managing a sizeable institution. She has no expertise in drug approvals.”

Former commissioners of CBER would “be deeply familiar with regulatory frameworks and the underlying principles of drug development”, said a former acting FDA commissioner. “Clearly, she doesn’t have the sort of resume that prior appointees who ran CBER have had.”

CDER has an immense portfolio at the FDA, Woodcock pointed out.

“Everybody just focuses on the new drug program, but the generic program approves a multitude of generic medications. There is also a biologic copycat branch, OTC medication office and so forth, and each of these need to be managed,” Woodcock said. “The responsibility you neglect, that is the part that I always told people is going to come back to haunt you.”

There is also, a major administrative aspect to the position, which manages in excess of 5,000 staff members. “It’s a huge administrative position, if you perform it correctly,” she added.

Official Statement and Contentious Policies

In response to questions about Høeg’s qualifications and whether this appointment represents increased cooperation among agency officials on vaccines, a representative stated that the “inquiries stem from flawed assumptions”.

“Her resume matches the responsibilities of her job,” the representative explained, noting the time Dr. Høeg spent counseling the agency head on “drug safety and regulatory science, including computerized risk analysis and shot safety tracking”.

As acting director, Dr. Høeg inherits the commissioner’s recently launched fast-track approval initiative, a disputed rapid drug-approval program that apparently concerned her former heads. “How are these medications being chosen for this fast-track system? Who is making the calls?” Howard asked. “There is a lot of confidentiality going on at the regulatory body right now.”

In general, he stated, “the Food and Drug Administration appears to be shifting towards laxer rules of most medications, aside from immunizations.”

Established History on Vaccines

Regarding immunizations, Høeg has a more documented, if concerning, track record, some experts said. She authored a research paper using non-validated volunteer-provided data to determine the rate of myocarditis following Covid vaccination. She advised the state of Florida top health official Dr. Joseph Ladapo, who reportedly have changed statistics to imply Covid vaccines are more dangerous than they are.

Part of her “policy goals” for the new administration featured revising regulations for new vaccines and discontinuing “non-essential” immunizations, she stated post-election on a online show. At the agency, Høeg has reportedly floated the idea of barring young men from receiving COVID-19 vaccinations.

“She is an complete ideologue who starts off with her preconceived notions and tailors the evidence to retrofit the science in a highly misleading, fraudulent way,” Howard stated.

Gaining Influence and a “Campaign of Retribution”

Dr. Høeg became part of other contrarians, {like|