🔗 Share this article

Given that the US proceeds with unprecedented revisions to its vaccine schedules, a particular individual has surfaced somewhat surprisingly: Høeg, a Danish American sports physician and public health researcher who rose to prominence by questioning coronavirus shots throughout the pandemic and has concentrated on potential deaths after Covid vaccination in her short time at the US Food and Drug Administration (FDA).

Planned Changes to Childhood Vaccine Schedule

Public health authorities had intended to unveil radical changes to the pediatric vaccination calendar earlier this month, aligning the US with Denmark’s immunization schedule, it is understood – a major change that would put the US out of step with a large portion of the world with insufficient data for improved outcomes. The planned update has been pushed back until the coming year.

In place of the director of the vaccine center, Dr. Høeg is set to address the audience at the meeting. She was just designated interim head of the FDA’s CDER, the fifth appointee to head the center this year.

A Shift at the Agency

The acting appointment could signify a closer partnership between the drug and biologics divisions as Høeg and Dr. Prasad solidify control at the agency – and it suggests a greater focus upon rolling back long-standing vaccines at the FDA.

Høeg has repeatedly called for discontinuing some childhood shot schedules in the US in order to be more in line with Denmark's approach, a society with nationalized medicine and a citizenry roughly the population of the state of Wisconsin.

In her initial comments, she has continued to focus on vaccination policy – typically the domain of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to pharmaceutical oversight.

Questions Over Background

Dr. Høeg has no obvious experience in drug development, oversight or administrative roles, which has been customary for former directors of the Center for Biologics Evaluation and Research. She has worked at the FDA as a top consultant to the agency head and CBER since earlier this year.

“She appears not to have the requisite experience” for overseeing the CDER, said a neurologist and psychiatrist. “She lacks experience running a clinical trial. She is not versed in leading a sizeable institution. She has no expertise in industry regulation.”

Past heads of CBER would “grasp laws and regulations and the research of drug development”, commented a former acting FDA commissioner. “Objectively, she has not acquired the sort of resume that prior appointees who ran the center have had.”

CDER has an vast range of responsibilities at the agency, the former commissioner stated.

“The public just zeroes in on the novel medication approvals, but the generic drug division clears thousands of generic drugs. There is also a biosimilars program, non-prescription drug unit and more, and all of those need to be supervised,” she explained. “The area you neglect, 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 supervises in excess of 5,000 employees. “It is a huge administrative position, if you do it right,” Woodcock said.

Official Statement and Disputed Policies

In response to questions about Dr. Høeg's fitness for the role and whether this assignment signifies increased cooperation among agency officials on immunizations, a spokesperson said that the “questions stem from inaccurate presumptions”.

“This background aligns with the functions of her position,” the spokesperson said, citing the period Dr. Høeg spent counseling the agency head on “pharmaceutical safety and oversight research, including computational safety modeling and shot safety tracking”.

As acting director, Høeg takes over the agency head's controversial priority voucher program, a contentious one-day drug-approval program that reportedly concerned her preceding directors. “By what process are these therapies being picked for this expedited pathway? Who makes the calls?” Howard questioned. “There is a lot of confidentiality going on at the FDA right now.”

Broadly speaking, he stated, “the Food and Drug Administration seems to be moving towards less stringent rules of pharmaceuticals, except for shots.”

Documented Track Record on Vaccines

Regarding immunizations, Høeg has a more documented, if troubling, history, critics said. She authored a study using unconfirmed crowd-sourced reports to estimate the frequency of myocarditis after Covid immunization. She consulted for the Florida surgeon general Joseph Ladapo, who allegedly have changed statistics to indicate Covid vaccines are riskier than they are.

Among her “desired changes” for the incoming administration featured altering guidelines for new vaccines and halting “non-essential” vaccines, she said post-election on a podcast. At the agency, Høeg has allegedly floated the idea of excluding young men from obtaining COVID-19 vaccines.

“She’s an all-around true believer who begins with her beliefs and reverse-engineers to fit the evidence in a highly deceptive, fraudulent way,” Dr. Howard stated.

Gaining Influence and a “Revenge Tour”

Høeg aligned with other skeptics, {like|