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While America proceeds with unprecedented revisions to its vaccine recommendations, one figure has emerged somewhat surprisingly: Høeg, a Danish American sports physician and public health researcher who rose to prominence by questioning COVID-19 shots during the pandemic and has zeroed in on possible fatalities following Covid immunization in her short position at the Food and Drug Administration.

Proposed Shifts to Childhood Vaccine Schedule

Agency leaders planned to unveil sweeping changes to the childhood immunization program recently, bringing the US with the Danish immunization schedule, sources say – a significant shift that would place the US at odds with a large portion of the world with no evidence for improved outcomes. The planned update has been delayed until the next year.

Instead of Vinay Prasad, Dr. Høeg is scheduled to present at the event. She was just designated interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to head the center this calendar year.

A Shift at the FDA

This interim role could signify a closer partnership between the drug and vaccine centers as Høeg and Prasad solidify control at the regulatory agency – and it signals a renewed priority upon rolling back long-standing immunizations at the FDA.

Høeg has repeatedly called for discontinuing certain childhood immunization guidelines in the US in order to be more similar to Denmark's approach, a nation with universal health coverage and a population approximately the size of the state of Wisconsin.

So far comments, she has persisted in emphasizing on immunizations – traditionally the domain of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to medication approval.

Doubts Over Background

The appointee has little discernible experience in pharmaceutical research, approval processes or management, which has been standard for former heads of the biologics center. She has worked at the FDA as a key advisor to the commissioner and the vaccine center since March.

“It seems she lacks to have any of the qualifications” for leading the pharmaceutical oversight division, remarked Dr. Jonathan Howard. “She has not conducted a scientific study. She is not versed in running a large organization. She is not an expert in drug approvals.”

Past heads of the center would “be deeply familiar with laws and regulations and the science of pharmaceutical innovation”, commented Dr. Janet Woodcock. “Clearly, she doesn’t have the sort of resume that previous people who ran the center have had.”

The drug center has an immense range of responsibilities at the agency, she pointed out.

“Everybody just focuses on the innovative therapies, but the generic drug division authorizes thousands of generic medications. There is also a biosimilars division, OTC medication office and so forth, and all of those must be supervised,” she explained. “The thing you overlook, that is the part that I always told people is going to cause problems.”

There is also, a significant management aspect to the job, which oversees over 5,000 staff members. “It is a enormous administrative position, if you do it right,” Woodcock said.

Official Statement and Controversial Programs

When asked about questions about Dr. Høeg's qualifications and whether this selection represents more teamwork among regulatory chiefs on immunizations, a press secretary responded that the “inquiries rely on flawed assumptions”.

“Her resume is consistent with the functions of her role,” the official explained, noting the months Dr. Høeg spent counseling the agency head on “medication safety and regulatory science, including predictive safety algorithms and immunization monitoring”.

As the temporary head, Høeg assumes responsibility for the commissioner’s controversial priority voucher program, a controversial expedited medication authorization process that allegedly troubled her preceding directors. “How are these therapies being chosen for this voucher program? Who takes the decisions?” Dr. Howard questioned. “There is a lot of secrecy occurring at the FDA right now.”

In general, he stated, “the FDA looks to be trending towards laxer rules of all drugs, with the exception of vaccines.”

Public Past Work on Immunizations

Regarding immunizations, Høeg has a clearer, if troubling, track record, Howard said. She released a research paper using unconfirmed public submissions to determine the incidence of heart inflammation following Covid immunization. She advised the state of Florida surgeon general Joseph Ladapo, who allegedly have altered data to suggest Covid vaccinations are more dangerous than they are.

Among her “policy goals” for the current government encompassed changing guidelines for recently developed shots and halting “unnecessary” immunizations, she stated following the vote on a podcast. At the agency, Dr. Høeg has allegedly floated the idea of excluding young men from obtaining Covid vaccinations.

“She’s an complete true believer who begins with her beliefs and tailors the evidence to fit the evidence in a highly misleading, untruthful manner,” Howard argued.

Taking Control and a “Campaign of Retribution”

Høeg joined other dissenters, {like|