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Given that the United States proceeds with unprecedented changes to its vaccination recommendations, a particular individual has emerged unexpectedly: Høeg, an American of Danish descent sports medicine doctor and public health researcher who first made her name by expressing skepticism about coronavirus vaccinations in the global health crisis and has zeroed in on alleged deaths following COVID-19 vaccination in her short time at the Food and Drug Administration.

Planned Changes to Pediatric Immunization Schedule

Public health authorities were set to reveal major revisions to the childhood immunization program recently, aligning the US with the Danish national calendar, it is understood – a substantial departure that would place the US out of alignment with much of the global community with no evidence for improved outcomes. The announcement has been postponed until the new year.

Rather than the director of the vaccine center, Dr. Høeg is set to present at the meeting. She was just designated temporary leader of the FDA’s CDER, the fifth person to head the center this year.

A Shift at the Agency

This interim role could signify a tighter collaboration between the pharmaceutical and biologics centers as Høeg and Dr. Prasad strengthen their influence at the regulatory agency – and it signals a increased emphasis upon rolling back already-approved immunizations at the FDA.

The new acting director has repeatedly called for halting certain pediatric immunization guidelines in the US to become more similar to Denmark, a society with comprehensive healthcare and a population approximately the size of Wisconsin’s.

So far public appearances, she has kept her attention on vaccination policy – traditionally the domain of Dr. Prasad, head of the FDA’s CBER – as opposed to medication approval.

Concerns Over Qualifications

The appointee has little discernible experience in pharmaceutical research, regulation or administrative roles, which has been standard for previous leaders of the biologics center. She has served at the FDA as a senior adviser to the commissioner and the vaccine center since March.

“She doesn’t seem to have the requisite experience” for running the drug-regulation department, stated Jonathan Howard. “She’s never run a scientific study. She is not versed in leading a large organization. She is not an expert in industry regulation.”

Former heads of CBER would “understand regulatory frameworks and the science of drug development”, noted Dr. Janet Woodcock. “Frankly, she doesn’t have the type of experience that previous people who headed CBER have had.”

This division has an immense range of responsibilities at the FDA, the former commissioner stated.

“Everybody just pays attention on the novel medication approvals, but the generic drug division clears a multitude of generic medications. There’s a biologic copycat branch, non-prescription drug unit and other areas, and each of these have to be supervised,” Dr. Woodcock explained. “The responsibility you neglect, that’s the thing that I always told people is going to come back to haunt you.”

Furthermore, a major leadership element to the role, which manages over 5,000 employees. “It is a massive leadership role, if you do it right,” Woodcock said.

Response and Controversial Programs

In response to inquiries about Høeg’s qualifications and whether this assignment represents more teamwork among regulatory chiefs on vaccines, a representative responded that the “inquiries rely on inaccurate assumptions”.

“Her experience matches the duties of her position,” the official said, noting the period Høeg spent advising the FDA commissioner on “medication safety and regulatory science, including computational safety modeling and immunization monitoring”.

In her interim role, Dr. Høeg inherits the commissioner’s new priority voucher program, a contentious rapid medication authorization process that reportedly concerned her predecessors. “How are these therapies being chosen for this fast-track system? Who makes the decisions?” Dr. Howard said. “There is a lot of lack of transparency happening at the FDA right now.”

In general, he said, “the agency appears to be shifting towards laxer rules of pharmaceuticals, with the exception of immunizations.”

Public History on Vaccines

With immunizations, Høeg has a clearer, if troubling, past, critics observe. She published a analysis using unverified public submissions to determine the incidence of myocarditis after COVID-19 immunization. She consulted for the state of Florida top health official Joseph Ladapo, who reportedly have changed statistics to suggest COVID-19 vaccines are riskier than they are.

Part of her “desired changes” for the current federal leadership encompassed changing rules for novel immunizations and ending “optional” immunizations, she said post-election on a online show. At the agency, Høeg has according to sources proposed preventing young men from receiving Covid vaccines.

“She’s an thorough ideologue who commences with her preconceived notions and tailors the evidence to fit the data in a extremely disingenuous, untruthful manner,” Howard said.

Taking Control and a “Campaign of Retribution”

Høeg became part of other skeptics, {like|