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As the United States continues making sweeping revisions to its immunization guidelines, a particular individual has surfaced somewhat surprisingly: Høeg, a Danish American physician and epidemiologist who first made her name by questioning Covid vaccines throughout the pandemic and has concentrated on potential deaths after Covid immunization in her short time at the Food and Drug Administration.

Proposed Shifts to Pediatric Immunization Schedule

Agency leaders were set to announce radical changes to the childhood vaccination calendar in December, synchronizing the US with the Danish vaccine program, sources say – a substantial departure that would put the US out of alignment with much of the world with little proof for improved outcomes. The announcement has been delayed until the new year.

Rather than the top vaccines chief, Dr. Høeg is listed to present at the gathering. She was just designated acting director of the FDA’s CDER, the fifth individual to run the center this year.

Consolidating Power at the Regulatory Body

The acting appointment may indicate a closer partnership between the pharmaceutical and biologics branches as Dr. Høeg and Prasad consolidate power at the regulatory agency – and it suggests a greater focus upon dismantling already-approved immunizations at the FDA.

The new acting director has often pushed for ending certain pediatric vaccine recommendations in the US to become more like Denmark's approach, a country with nationalized medicine and a population roughly the size of the state of Wisconsin.

To date public appearances, she has persisted in emphasizing on vaccines – typically the domain of Prasad, head of the FDA’s vaccine center – rather than medication approval.

Doubts Over Qualifications

The appointee has little discernible background in pharmaceutical research, oversight or administrative roles, which has been standard for previous heads of the biologics center. She has been employed at the FDA as a senior adviser to the agency head and CBER since earlier this year.

“She doesn’t seem to have any of the qualifications” for leading the pharmaceutical oversight division, stated a neurologist and psychiatrist. “She has not conducted a clinical trial. She has no expertise in managing a major agency. She is not an expert in pharmaceutical oversight.”

Previous commissioners of the center would “grasp legal statutes and the science of medication creation”, commented Dr. Janet Woodcock. “Frankly, she has not acquired the kind of background that former directors who led the center have had.”

This division has an vast workload at the FDA, she stated.

“Everybody just focuses on the novel medication approvals, but the generic program approves a multitude of off-brand pharmaceuticals. There is also a biologic copycat branch, non-prescription drug unit and other areas, and every single one need to be managed,” Woodcock noted. “The area you overlook, that’s the thing that I always told people is going to come back to haunt you.”

Additionally, a significant leadership component to the position, which oversees more than 5,000 staff members. “It is a huge management job, if you perform it correctly,” she said.

Response and Controversial Programs

When asked about inquiries about Dr. Høeg's credentials and whether this selection represents increased cooperation among FDA leaders on vaccines, a representative said that the “concerns stem from inaccurate presumptions”.

“Her resume matches the responsibilities of her position,” the spokesperson said, noting the time Dr. Høeg spent advising the agency head on “pharmaceutical safety and oversight research, including computational safety modeling and immunization monitoring”.

In her interim role, Høeg inherits the commissioner’s recently launched fast-track approval initiative, a disputed expedited therapy clearance system that apparently worried her former heads. “By what process are these therapies being chosen for this expedited pathway? Who is making the calls?” Howard said. “There’s a lot of confidentiality occurring at the FDA right now.”

Overall, he stated, “the Food and Drug Administration appears to be shifting towards more relaxed rules of pharmaceuticals, with the exception of immunizations.”

Documented Track Record on Immunizations

Regarding immunizations, Dr. Høeg has a more documented, if problematic, track record, Howard have noted. She released a research paper using non-validated crowd-sourced reports to assess the incidence of heart inflammation following COVID-19 immunization. She counseled the Florida chief medical officer Dr. Joseph Ladapo, who reportedly have altered data to imply Covid vaccinations are riskier than they are.

Included in her “wish list” for the new administration featured revising guidelines for novel immunizations and discontinuing “unnecessary” immunizations, she stated after the election on a podcast. At the FDA, Dr. Høeg has reportedly proposed preventing young men from receiving COVID-19 vaccinations.

“She is an thorough ideologue who starts off with her beliefs and tailors the evidence to fit the science in a extremely deceptive, dishonest way,” Dr. Howard said.

Consolidating Power and a “Revenge Tour”

Dr. Høeg joined fellow skeptics, {like|