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While the US continues making unprecedented changes to its vaccine recommendations, one figure has emerged in a surprising turn: Dr. Tracy Beth Høeg, a Danish American sports medicine doctor and public health researcher who initially gained attention by questioning Covid vaccinations throughout the pandemic and has focused upon alleged deaths following COVID-19 immunization in her brief time at the US Food and Drug Administration (FDA).

Scheduled Overhauls to Childhood Vaccine Program

Public health authorities had intended to reveal sweeping changes to the childhood vaccination calendar recently, bringing the US with the Danish national calendar, according to reports – a substantial departure that would place the US out of alignment with many the world with no evidence for improved outcomes. The announcement has been delayed until the coming year.

In place of Vinay Prasad, Høeg is listed to address the audience at the event. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to lead the division this calendar year.

A Shift at the Agency

Høeg's temporary position might represent a strengthened alliance between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad consolidate power at the agency – and it signals a increased emphasis upon reevaluating long-standing vaccines at the FDA.

Dr. Høeg has often pushed for ending some childhood immunization guidelines in the US so as to align more in line with the Danish model, a country with comprehensive healthcare and a citizenry roughly the size of Wisconsin’s.

In her initial comments, she has continued to focus on immunizations – typically the domain of Dr. Prasad, chief of the FDA’s vaccine center – rather than drug regulation.

Concerns Over Qualifications

Høeg has no obvious track record in pharmaceutical research, regulation or management, which has been typical for past heads of the CBER. She has worked at the FDA as a key advisor to the commissioner and the vaccine center since spring.

“She appears not to have the requisite experience” for leading the CDER, stated a neurologist and psychiatrist. “She lacks experience running a randomized controlled trial. She is not versed in leading a major agency. She has no expertise in pharmaceutical oversight.”

Former heads of CBER would “be deeply familiar with regulatory frameworks and the research of pharmaceutical innovation”, noted Dr. Janet Woodcock. “Objectively, she lacks the kind of background that prior appointees who headed CBER have had.”

CDER has an enormous portfolio at the agency, the former commissioner emphasized.

“Many people just zeroes in on the novel medication approvals, but the generic program approves numerous generic drugs. There is also a biosimilars program, OTC medication office and so forth, and each of these need to be managed,” she noted. “The area you neglect, that’s the thing that I always told people is going to bite you.”

Furthermore, a substantial administrative component to the job, which manages more than 5,000 employees. “It’s a enormous management job, if you do it right,” she added.

Agency Reaction and Controversial Initiatives

When asked about concerns about Høeg’s credentials and whether this appointment represents increased cooperation among agency officials on vaccines, a spokesperson responded that the “concerns rely on flawed presumptions”.

“This background aligns with the duties of her job,” the spokesperson said, noting the months Dr. Høeg spent guiding the FDA commissioner on “drug safety and approval science, including computational safety modeling and vaccine surveillance”.

As the temporary head, Høeg inherits the commissioner’s new priority voucher program, a controversial one-day therapy clearance system that apparently troubled her former heads. “By what process are these therapies being selected for this voucher program? Who is making the calls?” Dr. Howard questioned. “There is a lot of confidentiality happening at the regulatory body right now.”

Broadly speaking, he stated, “the FDA appears to be shifting towards more relaxed oversight of most medications, except for vaccines.”

Public Past Work on Immunizations

Concerning immunizations, Dr. Høeg has a more documented, if troubling, past, some experts observe. She released a study using unconfirmed volunteer-provided data to determine the incidence of myocarditis following COVID-19 immunization. She advised the state of Florida chief medical officer Dr. Joseph Ladapo, who was said to have modified findings to imply COVID-19 vaccinations are pose a greater threat than they are.

Among her “policy goals” for the incoming government included altering rules for new vaccines and halting “unnecessary” vaccines, she said after the election on a podcast. At the FDA, Høeg has according to sources floated the idea of preventing teenage boys from receiving COVID-19 vaccinations.

“She’s an thorough ideologue who commences with her preconceived notions and tailors the evidence to accommodate the evidence in a highly misleading, untruthful fashion,” Howard argued.

Taking Control and a “Revenge Tour”

Dr. Høeg aligned with fellow contrarians, {like|