🔗 Share this article

Given that the US proceeds with historic changes to its immunization guidelines, one figure has emerged unexpectedly: Høeg, a Danish American physician and public health researcher who first made her name by questioning COVID-19 shots during the global health crisis and has focused upon possible fatalities after COVID-19 immunization in her short time at the US Food and Drug Administration (FDA).

Proposed Shifts to Childhood Vaccine Schedule

Agency leaders had intended to announce radical revisions to the childhood vaccination calendar recently, aligning the US with the Danish vaccine program, it is understood – a significant shift that would put the US out of alignment with many the global community with insufficient data for improved outcomes. This reveal has been postponed until the coming year.

Instead of the director of the vaccine center, Dr. Høeg is listed to speak at the gathering. She was recently named interim head of the FDA’s drug evaluation center, the fifth person to lead the center this year.

Consolidating Power at the FDA

This interim role could signify a closer partnership between the pharmaceutical and biologics branches as Høeg and Prasad solidify control at the FDA – and it points to a renewed priority upon rolling back previously authorized vaccines at the FDA.

The new acting director has repeatedly called for halting certain pediatric vaccine recommendations in the US so as to align more like Denmark, a society with nationalized medicine and a number of inhabitants approximately the size of Wisconsin’s.

In her initial statements, she has persisted in emphasizing on immunizations – typically the purview of Prasad, head of the FDA’s vaccine center – rather than drug regulation.

Questions Over Expertise

Dr. Høeg has little discernible experience in medication creation, approval processes or management, which has been customary for former directors of the biologics center. She has worked at the FDA as a key advisor to the commissioner and the vaccine center since spring.

“It seems she lacks to have the requisite experience” for running the drug-regulation department, remarked Jonathan Howard. “She’s never run a scientific study. She is not versed in running a major agency. She is not an expert in pharmaceutical oversight.”

Former commissioners of the center would “understand legal statutes and the science of drug development”, noted Dr. Janet Woodcock. “Objectively, she lacks the kind of background that former directors who ran CBER have had.”

CDER has an vast portfolio at the FDA, the former commissioner stated.

“The public just pays attention on the novel medication approvals, but the generic drug division approves thousands of generic drugs. There is also a biosimilars program, OTC medication office and other areas, and every single one need to be managed,” Woodcock noted. “The responsibility you neglect, that’s the thing that I always told people is going to cause problems.”

Furthermore, a significant leadership aspect to the job, which supervises in excess of 5,000 personnel. “It is a massive leadership role, if you perform it correctly,” Woodcock said.

Agency Reaction and Disputed Initiatives

When asked about inquiries about Dr. Høeg's fitness for the role and whether this selection indicates increased cooperation among FDA leaders on immunizations, a spokesperson stated that the “concerns are based on flawed assumptions”.

“This background aligns with the duties of her role,” the representative stated, pointing to the months Dr. Høeg spent guiding the agency head on “medication safety and regulatory science, including computerized risk analysis and vaccine surveillance”.

As acting director, Høeg assumes responsibility for the agency head's recently launched priority voucher program, a disputed rapid therapy clearance system that allegedly worried her predecessors. “How are these therapies being selected for this voucher program? Who takes the calls?” Dr. Howard questioned. “There is a lot of confidentiality going on at the agency right now.”

Overall, he stated, “the Food and Drug Administration seems to be moving towards less stringent rules of all drugs, except for shots.”

Documented Track Record on Immunizations

Concerning vaccines, Høeg has a more established, if concerning, past, critics observe. She published a study using unverified crowd-sourced reports to estimate the rate of myocarditis following COVID-19 vaccination. She advised the state of Florida surgeon general Dr. Joseph Ladapo, who was said to have changed statistics to indicate COVID-19 vaccinations are riskier than they are.

Included in her “wish list” for the incoming administration encompassed changing rules for new vaccines and halting “optional” immunizations, she stated following the vote on a online show. At the agency, Høeg has allegedly suggested barring adolescent males from getting COVID-19 vaccines.

“She is an thorough true believer who starts off with her preconceived notions and tailors the evidence to accommodate the science in a highly disingenuous, fraudulent fashion,” Dr. Howard stated.

Taking Control and a “Push for Payback”

Dr. Høeg joined other contrarians, {like|