🔗 Share this article

While the US undertakes sweeping revisions to its immunization guidelines, one figure has emerged in a surprising turn: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by casting doubt on coronavirus vaccines in the pandemic and has concentrated on potential deaths following COVID-19 vaccination in her recent position at the US Food and Drug Administration (FDA).

Proposed Shifts to Pediatric Immunization Program

Agency leaders were set to reveal major revisions to the childhood vaccination calendar in December, bringing the US with Denmark’s national calendar, sources say – a substantial departure that would place the US out of alignment with much of the international standard with no evidence for public health gain. This reveal has been pushed back until the new year.

In place of Vinay Prasad, Høeg is listed to speak at the meeting. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to head the office this year.

A Shift at the Regulatory Body

The acting appointment may indicate a tighter collaboration between the pharmaceutical and biologics centers as Høeg and Prasad consolidate power at the FDA – and it signals a renewed priority upon rolling back long-standing immunizations at the FDA.

Høeg has frequently advocated for halting certain pediatric immunization guidelines in the US to become more in line with Denmark, a nation with universal health coverage and a number of inhabitants approximately the population of Wisconsin’s.

In her initial public appearances, she has kept her attention on immunizations – typically the domain of Dr. Prasad, head of the FDA’s CBER – rather than pharmaceutical oversight.

Doubts Over Qualifications

Dr. Høeg has no obvious experience in medication creation, approval processes or administrative roles, which has been typical for former directors of the biologics center. She has served at the FDA as a top consultant to the commissioner and the vaccine center since earlier this year.

“It seems she lacks to have any of the qualifications” for leading the drug-regulation department, remarked Jonathan Howard. “She’s never run a scientific study. She lacks experience in managing a major agency. She has no expertise in drug approvals.”

Previous heads of CBER would “understand regulatory frameworks and the science of medication creation”, noted Janet Woodcock. “Clearly, she has not acquired the sort of resume that prior appointees who led the center have had.”

The drug center has an immense portfolio at the FDA, Woodcock stated.

“Many people just pays attention on the novel medication approvals, but the generic drug division approves numerous generic medications. There’s a biosimilars division, non-prescription drug unit and other areas, and all of those need to be managed,” she explained. “The thing you neglect, that is the part that I always told people is going to bite you.”

Furthermore, a significant leadership component to the role, which supervises more than 5,000 staff members. “It is a huge management job, if you do it right,” the former official concluded.

Agency Reaction and Contentious Policies

In response to inquiries about Høeg’s credentials and whether this assignment signifies increased cooperation among agency officials on immunizations, a spokesperson said that the “inquiries stem from inaccurate assumptions”.

“Her resume matches the duties of her job,” the representative said, citing the period Dr. Høeg spent counseling the agency head on “drug safety and approval science, including predictive safety algorithms and shot safety tracking”.

As acting director, Høeg takes over the agency head's controversial fast-track approval initiative, a controversial rapid drug-approval program that allegedly troubled her preceding directors. “How are these medications being selected for this fast-track system? Who takes the calls?” Howard said. “There’s a lot of lack of transparency going on at the agency right now.”

In general, he remarked, “the Food and Drug Administration appears to be shifting towards laxer oversight of most medications, except for immunizations.”

Established History on Vaccines

Concerning vaccines, Høeg has a more established, if problematic, history, critics said. She authored a analysis using unverified crowd-sourced reports to determine the rate of myocarditis after COVID-19 immunization. She advised the state of Florida surgeon general Joseph Ladapo, who reportedly have modified findings to indicate Covid vaccines are more dangerous than they are.

Among her “wish list” for the new government featured changing rules for new vaccines and discontinuing “unnecessary” immunizations, she remarked after the election on a online show. At the agency, Høeg has reportedly floated the idea of excluding young men from getting COVID-19 vaccinations.

“She’s an complete true believer who begins with her beliefs and reverse-engineers to accommodate the evidence in a very disingenuous, fraudulent fashion,” Dr. Howard said.

Gaining Influence and a “Push for Payback”

Høeg became part of fellow dissenters, {like|