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Given that the US proceeds with historic adjustments to its vaccine guidelines, an unexpected name appears unexpectedly: Høeg, a Danish American sports physician and public health researcher who rose to prominence by casting doubt on Covid vaccinations during the global health crisis and has focused upon possible deaths after Covid immunization in her recent position at the Food and Drug Administration.

Scheduled Shifts to Pediatric Vaccine Program

Agency leaders had intended to unveil sweeping revisions to the childhood vaccine schedule in December, synchronizing the US with the Danish immunization schedule, it is understood – a significant shift that would place the US at odds with a large portion of the global community with no evidence for improved outcomes. The planned update has been delayed until the new year.

In place of Vinay Prasad, Høeg is set to speak at the event. She was recently named interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to lead the division this calendar year.

A New Direction at the FDA

The acting appointment might represent a closer partnership between the drug and vaccine branches as Dr. Høeg and Dr. Prasad solidify control at the FDA – and it suggests a renewed priority upon rolling back already-approved immunizations at the FDA.

Dr. Høeg has often pushed for discontinuing some pediatric immunization guidelines in the US so as to align more in line with Denmark, a society with universal health coverage and a citizenry roughly the population of the state of Wisconsin.

In her initial public appearances, she has continued to focus on vaccination policy – typically the purview of Dr. Prasad, director of the FDA’s vaccine center – as opposed to medication approval.

Doubts Over Qualifications

The appointee has no apparent track record in drug development, regulation or leadership, which has been typical for past heads of the Center for Biologics Evaluation and Research. She has served at the FDA as a key advisor to the commissioner and the vaccine center since March.

“She doesn’t seem to have the requisite experience” for leading the pharmaceutical oversight division, remarked Jonathan Howard. “She has not conducted a randomized controlled trial. She lacks experience in managing a major agency. She is not an expert in pharmaceutical oversight.”

Former heads of CBER would “understand legal statutes and the science of pharmaceutical innovation”, said Dr. Janet Woodcock. “Frankly, she doesn’t have the sort of resume that previous people who ran CBER have had.”

CDER has an enormous portfolio at the FDA, Woodcock pointed out.

“Everybody just focuses on the novel medication approvals, but the generic drug division clears numerous generic medications. There’s a biologic copycat branch, OTC medication office and other areas, and every single one must be looked after,” Woodcock said. “The area you don’t keep your eye on, that is precisely what that I always told people is going to cause problems.”

Furthermore, a significant administrative element to the position, which supervises over 5,000 personnel. “It’s a huge management job, if you execute it properly,” Woodcock concluded.

Agency Reaction and Disputed Programs

In response to concerns about Dr. Høeg's qualifications and whether this assignment represents greater collaboration among agency officials on vaccines, a press secretary stated that the “questions rely on incorrect assumptions”.

“Her resume aligns with the duties of her position,” the spokesperson stated, noting the months Høeg spent guiding the FDA commissioner on “drug safety and approval science, including computerized risk analysis and vaccine surveillance”.

As the temporary head, Høeg takes over the commissioner’s new priority voucher program, a controversial rapid therapy clearance system that apparently worried her predecessors. “By what process are these drugs being selected for this expedited pathway? Who makes the decisions?” Howard asked. “There’s a lot of secrecy happening at the agency right now.”

Overall, he remarked, “the FDA appears to be shifting towards more relaxed oversight of pharmaceuticals, with the exception of shots.”

Public Past Work on Vaccines

Regarding vaccines, Dr. Høeg has a more established, if troubling, history, some experts said. She authored a research paper using non-validated crowd-sourced reports to assess the frequency of myocarditis after COVID-19 vaccination. She counseled the Florida chief medical officer Joseph Ladapo, who reportedly have modified findings to indicate Covid vaccinations are more dangerous than they are.

Among her “policy goals” for the new government included changing guidelines for new vaccines and discontinuing “unnecessary” immunizations, she stated following the vote on a podcast. At the agency, Dr. Høeg has reportedly proposed excluding adolescent males from receiving COVID-19 vaccines.

“She is an all-around dogmatist who begins with her beliefs and tailors the evidence to retrofit the science in a highly misleading, untruthful manner,” Dr. Howard stated.

Taking Control and a “Revenge Tour”

Dr. Høeg aligned with fellow dissenters, {like|