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As the United States continues making unprecedented changes to its immunization schedules, one figure appears in a surprising turn: Høeg, an American of Danish descent sports physician and public health researcher who rose to prominence by questioning COVID-19 vaccinations throughout the global health crisis and has zeroed in on alleged fatalities following COVID-19 vaccination in her short time at the US Food and Drug Administration (FDA).

Scheduled Overhauls to Childhood Immunization Program

Health officials planned to announce major revisions to the pediatric immunization program earlier this month, aligning the US with the Danish immunization schedule, according to reports – a significant shift that would place the US out of step with many the world with little proof for improved outcomes. The planned update has been postponed until the next year.

In place of Vinay Prasad, Høeg is set to speak at the gathering. She was just designated acting director of the FDA’s CDER, the fifth appointee to run the center this year.

A Shift at the FDA

The acting appointment may indicate a strengthened alliance between the drug and vaccine branches as Dr. Høeg and Dr. Prasad solidify control at the agency – and it signals a greater focus upon reevaluating previously authorized immunizations at the FDA.

Høeg has often pushed for halting specific childhood immunization guidelines in the US to become more similar to Denmark, a nation with nationalized medicine and a number of inhabitants about the size of Wisconsin’s.

To date statements, she has kept her attention on vaccines – traditionally the responsibility of Prasad, head of the FDA’s vaccine center – rather than pharmaceutical oversight.

Concerns Over Background

Dr. Høeg has little discernible track record in pharmaceutical research, regulation or administrative roles, which has been typical for previous directors of the biologics center. She has served 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 leading the pharmaceutical oversight division, said Jonathan Howard. “She lacks experience running a clinical trial. She is not versed in managing a major agency. She has no expertise in pharmaceutical oversight.”

Previous directors of CBER would “understand laws and regulations and the underlying principles of pharmaceutical innovation”, noted Dr. Janet Woodcock. “Clearly, she has not acquired the kind of background that previous people who headed the center have had.”

This division has an vast portfolio at the agency, she stated.

“Everybody just focuses on the innovative therapies, but the generic drug division approves thousands of generic medications. There is also a biologic copycat branch, OTC medication office and so forth, and all of those must be supervised,” she noted. “The thing you neglect, that is precisely what that I always told people is going to cause problems.”

Additionally, a substantial leadership element to the role, which oversees more than 5,000 personnel. “It’s a huge administrative position, if you do it right,” she said.

Response and Contentious Policies

Regarding inquiries about Dr. Høeg's qualifications and whether this assignment indicates more teamwork among FDA leaders on vaccines, a representative responded that the “questions stem from flawed presumptions”.

“Her resume is consistent with the responsibilities of her job,” the official stated, citing the period Dr. Høeg spent counseling the FDA commissioner on “drug safety and regulatory science, including computational safety modeling and immunization monitoring”.

As acting director, Høeg inherits the agency head's new priority voucher program, a contentious one-day drug-approval program that allegedly troubled her predecessors. “By what process are these drugs being picked for this fast-track system? Who takes the decisions?” Howard said. “There’s a lot of confidentiality happening at the regulatory body right now.”

Overall, he said, “the FDA seems to be moving towards laxer regulations of pharmaceuticals, aside from immunizations.”

Established Past Work on Immunizations

Regarding vaccines, Høeg has a more established, if concerning, history, some experts have noted. She published a study using non-validated public submissions to estimate the frequency of myocarditis following COVID-19 immunization. She consulted for the state of Florida surgeon general Joseph Ladapo, who was said to have altered data to suggest COVID-19 vaccinations are more dangerous than they are.

Among her “desired changes” for the current government encompassed revising guidelines for recently developed shots and ending “optional” vaccines, she stated following the vote on a audio program. At the agency, Dr. Høeg has reportedly proposed excluding teenage boys from getting COVID-19 vaccines.

“She’s an complete true believer who starts off with her beliefs and reverse-engineers to accommodate the evidence in a highly disingenuous, fraudulent manner,” Howard stated.

Consolidating Power and a “Campaign of Retribution”

Dr. Høeg aligned with other dissenters, {like|