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Given that the United States proceeds with unprecedented adjustments to its vaccine guidelines, one figure has emerged unexpectedly: Høeg, an American of Danish descent physician and epidemiologist who first made her name by expressing skepticism about COVID-19 vaccines during the global health crisis and has concentrated on alleged deaths after COVID-19 immunization in her recent tenure at the US Food and Drug Administration (FDA).

Scheduled Overhauls to Childhood Vaccine Schedule

Public health authorities had intended to announce radical changes to the childhood immunization program recently, synchronizing the US with the Danish immunization schedule, it is understood – a significant shift that would place the US out of step with much of the world with little proof for public health gain. The planned update has been pushed back until the coming year.

Rather than Vinay Prasad, Dr. Høeg is scheduled to present at the meeting. She was newly appointed temporary leader of the FDA’s CDER, the fifth appointee to head the office this calendar year.

A New Direction at the FDA

The acting appointment might represent a tighter collaboration between the drug and vaccine centers as Dr. Høeg and Prasad consolidate power at the regulatory agency – and it points to a greater focus upon rolling back already-approved immunizations at the FDA.

Dr. Høeg has repeatedly called for ending specific pediatric vaccine recommendations in the US to become more in line with Denmark's approach, a country with nationalized medicine and a citizenry about the size of Wisconsin’s.

In her initial statements, she has kept her attention on vaccination policy – traditionally the responsibility of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of pharmaceutical oversight.

Doubts Over Qualifications

Dr. Høeg has no apparent track record in drug development, approval processes or management, which has been typical for former directors of the CBER. She has been employed at the FDA as a top consultant to the agency head and CBER since earlier this year.

“She doesn’t seem to have the requisite experience” for leading the drug-regulation department, stated Dr. Jonathan Howard. “She lacks experience running a scientific study. She is not versed in leading a large organization. She is not an expert in pharmaceutical oversight.”

Previous commissioners of the center would “understand legal statutes and the science of medication creation”, said Dr. Janet Woodcock. “Clearly, she lacks the type of experience that former directors who led CBER have had.”

This division has an enormous workload at the FDA, the former commissioner stated.

“The public just zeroes in on the novel medication approvals, but the generic program approves thousands of generic medications. There’s a biologic copycat branch, non-prescription drug unit and more, and all of those must be looked after,” Dr. Woodcock noted. “The area you neglect, that is the part that I always told people is going to bite you.”

Additionally, a significant leadership aspect to the role, which oversees in excess of 5,000 personnel. “It is a massive leadership role, if you do it right,” she concluded.

Official Statement and Disputed Programs

Regarding concerns about Dr. Høeg's credentials and whether this assignment represents increased cooperation among regulatory chiefs on vaccines, a spokesperson said that the “concerns are based on inaccurate presumptions”.

“This background matches the functions of her position,” the representative said, pointing to the time Høeg spent advising the agency head on “medication safety and approval science, including computational safety modeling and vaccine surveillance”.

In her interim role, Høeg takes over the commissioner’s controversial expedited review system, a controversial rapid drug-approval program that reportedly worried her preceding directors. “By what process are these therapies being selected for this voucher program? Who makes the choices?” Dr. Howard asked. “There’s a lot of secrecy occurring at the FDA right now.”

Overall, he stated, “the FDA appears to be shifting towards laxer oversight of most medications, aside from shots.”

Documented Past Work on Immunizations

Regarding immunizations, Dr. Høeg has a more documented, if troubling, track record, Howard said. She published a analysis using unconfirmed crowd-sourced reports to assess the frequency of heart inflammation after COVID-19 immunization. She advised the state of Florida surgeon general Joseph Ladapo, who allegedly have altered data to imply Covid vaccines are pose a greater threat than they are.

Included in her “desired changes” for the incoming federal leadership encompassed altering regulations for novel immunizations and discontinuing “unnecessary” vaccines, she said post-election on a audio program. At the FDA, Dr. Høeg has reportedly floated the idea of barring young men from getting COVID-19 vaccinations.

“She is an all-around true believer who starts off with her preconceived notions and reverse-engineers to retrofit the evidence in a extremely misleading, untruthful manner,” Dr. Howard said.

Taking Control and a “Push for Payback”

Høeg joined other skeptics, {like|