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As the US proceeds with sweeping changes to its immunization schedules, a particular individual appears in a surprising turn: Høeg, an American of Danish descent sports medicine doctor and epidemiologist who first made her name by casting doubt on coronavirus shots during the global health crisis and has focused upon alleged fatalities following COVID-19 immunization in her short tenure at the FDA.

Planned Shifts to Childhood Immunization Program

Public health authorities had intended to unveil sweeping revisions to the childhood vaccine schedule in December, aligning the US with the Danish national calendar, sources say – a substantial departure that would put the US at odds with much of the global community with no evidence for improved outcomes. The announcement has been postponed until the new year.

In place of the top vaccines chief, Høeg is set to speak at the event. She was just designated temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to lead the office this year.

A Shift at the Regulatory Body

The acting appointment may indicate a closer partnership between the pharmaceutical and vaccine divisions as Dr. Høeg and Dr. Prasad consolidate power at the FDA – and it points to a renewed priority upon dismantling previously authorized vaccines at the FDA.

The new acting director has often pushed for ending certain pediatric shot schedules in the US so as to align more in line with the Danish model, a society with comprehensive healthcare and a number of inhabitants roughly the size of the state of Wisconsin.

To date public appearances, she has persisted in emphasizing on vaccination policy – traditionally the purview of Dr. Prasad, chief of the FDA’s CBER – instead of medication approval.

Questions Over Expertise

Høeg has no obvious experience in pharmaceutical research, oversight or administrative roles, which has been standard for former heads of the biologics center. She has been employed at the FDA as a key advisor to the agency head and the vaccine center since spring.

“She doesn’t seem to have any of the qualifications” for leading the CDER, remarked a neurologist and psychiatrist. “She lacks experience running a scientific study. She has no expertise in running a large organization. She has no expertise in pharmaceutical oversight.”

Former directors of the center would “grasp legal statutes and the underlying principles of medication creation”, commented Dr. Janet Woodcock. “Objectively, she has not acquired the kind of background that former directors who ran the center have had.”

This division has an immense portfolio at the agency, she pointed out.

“The public just zeroes in on the innovative therapies, but the off-patent medication office clears numerous generic medications. There is also a biologic copycat branch, over-the-counter program and other areas, and each of these must be supervised,” Woodcock noted. “The area you overlook, that is precisely what that I always told people is going to come back to haunt you.”

Furthermore, a substantial management aspect to the position, which oversees in excess of 5,000 personnel. “It’s a massive management job, if you execute it properly,” she said.

Response and Controversial Initiatives

When asked about inquiries about Dr. Høeg's qualifications and whether this assignment indicates increased cooperation among agency officials on immunizations, a spokesperson stated that the “concerns stem from inaccurate presumptions”.

“This background matches the responsibilities of her position,” the representative stated, citing the time Dr. Høeg spent counseling the agency head on “pharmaceutical safety and regulatory science, including computational safety modeling and shot safety tracking”.

As the temporary head, Høeg inherits the agency head's new priority voucher program, a disputed expedited therapy clearance system that reportedly troubled her former heads. “By what process are these medications being selected for this expedited pathway? Who takes the choices?” Howard asked. “There is a lot of confidentiality happening at the FDA right now.”

Broadly speaking, he stated, “the FDA appears to be shifting towards laxer oversight of all drugs, aside from shots.”

Public History on Vaccines

Concerning vaccines, Høeg has a more established, if concerning, past, critics said. She published a research paper using unverified crowd-sourced reports to assess the frequency of heart inflammation after Covid immunization. She consulted for the state of Florida chief medical officer Joseph Ladapo, who reportedly have changed statistics to imply Covid vaccinations are riskier than they are.

Part of her “wish list” for the incoming administration included changing guidelines for new vaccines and discontinuing “optional” vaccines, she remarked following the vote on a online show. At the agency, Dr. Høeg has allegedly proposed excluding teenage boys from getting COVID-19 vaccinations.

“She’s an complete dogmatist who begins with her beliefs and reverse-engineers to fit the evidence in a highly misleading, dishonest manner,” Dr. Howard argued.

Gaining Influence and a “Revenge Tour”

Høeg became part of fellow skeptics, {like|