🔗 Share this article

As the US proceeds with unprecedented revisions to its vaccine schedules, an unexpected name appears unexpectedly: Høeg, an American of Danish descent sports physician and public health researcher who first made her name by expressing skepticism about coronavirus vaccines during the pandemic and has concentrated on alleged fatalities following Covid immunization in her short position at the FDA.

Planned Changes to Childhood Immunization Schedule

Public health authorities planned to announce sweeping changes to the childhood vaccine schedule in December, bringing the US with Denmark’s immunization schedule, according to reports – a major change that would put the US out of alignment with much of the global community with insufficient data for benefit. The planned update has been delayed until the new year.

In place of the top vaccines chief, Tracy Beth Høeg is listed to present at the meeting. She was recently named interim head of the FDA’s drug evaluation center, the fifth appointee to lead the division this year.

A Shift at the Regulatory Body

Høeg's temporary position may indicate a tighter collaboration between the drug and vaccine centers as Høeg and Dr. Prasad strengthen their influence at the agency – and it signals a renewed priority upon dismantling long-standing immunizations at the FDA.

Dr. Høeg has repeatedly called for halting specific pediatric shot schedules in the US in order to be more in line with the Danish model, a society with nationalized medicine and a population about the population of Wisconsin’s.

So far statements, she has kept her attention on immunizations – traditionally the purview of Dr. Prasad, head of the FDA’s CBER – rather than medication approval.

Doubts Over Background

Dr. Høeg has no obvious track record in pharmaceutical research, regulation or administrative roles, which has been typical for former directors of the CBER. She has been employed at the FDA as a senior adviser to the FDA chief and CBER since earlier this year.

“She appears not to have any of the qualifications” for overseeing the drug-regulation department, said Jonathan Howard. “She lacks experience running a scientific study. She lacks experience in leading a large organization. She is not an expert in drug approvals.”

Previous heads of CBER would “understand regulatory frameworks and the research of drug development”, commented a former acting FDA commissioner. “Clearly, she has not acquired the sort of resume that previous people who led the center have had.”

CDER has an immense range of responsibilities at the FDA, the former commissioner emphasized.

“The public just zeroes in on the novel medication approvals, but the generic program clears thousands of generic drugs. There is also a biologic copycat branch, over-the-counter program and so forth, and all of those must be supervised,” she noted. “The area you don’t keep your eye on, that’s the thing that I always told people is going to cause problems.”

Additionally, a major management element to the role, which supervises more than 5,000 employees. “It’s a massive administrative position, if you perform it correctly,” she concluded.

Response and Disputed Programs

Regarding questions about Høeg’s credentials and whether this selection represents greater collaboration among regulatory chiefs on vaccines, a representative stated that the “questions are based on incorrect premises”.

“Her resume is consistent with the duties of her role,” the spokesperson said, noting the period Høeg spent guiding the FDA commissioner on “pharmaceutical safety and oversight research, including computational safety modeling and shot safety tracking”.

In her interim role, Dr. Høeg takes over the agency head's recently launched fast-track approval initiative, a controversial rapid medication authorization process that allegedly concerned her predecessors. “How are these medications being picked for this fast-track system? Who makes the calls?” Dr. Howard questioned. “There is a lot of confidentiality occurring at the regulatory body right now.”

In general, he stated, “the Food and Drug Administration appears to be shifting towards laxer regulations of all drugs, with the exception of immunizations.”

Documented Track Record on Vaccines

Concerning immunizations, Dr. Høeg has a more established, if troubling, history, some experts said. She authored a study using non-validated crowd-sourced reports to assess the frequency of myocarditis following COVID-19 vaccination. She advised the Florida chief medical officer Joseph Ladapo, who reportedly have altered data to indicate COVID-19 vaccinations are pose a greater threat than they are.

Among her “wish list” for the current administration included changing regulations for new vaccines and discontinuing “unnecessary” immunizations, she stated post-election on a audio program. At the agency, Høeg has allegedly proposed excluding young men from getting Covid vaccines.

“She is an complete dogmatist who begins with her preconceived notions and tailors the evidence to accommodate the science in a very misleading, dishonest manner,” Howard argued.

Gaining Influence and a “Campaign of Retribution”

Dr. Høeg joined other skeptics, {like|