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Given that the US continues making historic changes to its immunization guidelines, a particular individual appears somewhat surprisingly: Høeg, a US-based sports physician and public health researcher who rose to prominence by questioning Covid vaccines throughout the global health crisis and has concentrated on alleged deaths following Covid immunization in her brief time at the Food and Drug Administration.

Planned Overhauls to Childhood Immunization Program

Public health authorities had intended to unveil radical revisions to the childhood vaccination calendar in December, aligning the US with the Danish national calendar, sources say – a significant shift that would put the US out of alignment with a large portion of the global community with insufficient data for public health gain. The announcement has been delayed until the next year.

Instead of Vinay Prasad, Dr. Høeg is listed to address the audience at the meeting. She was recently named interim head of the FDA’s drug evaluation center, the fifth person to head the center this calendar year.

A Shift at the Agency

Høeg's temporary position could signify a tighter collaboration between the drug and biologics divisions as Dr. Høeg and Dr. Prasad consolidate power at the FDA – and it suggests a renewed priority upon dismantling long-standing immunizations at the FDA.

Høeg has repeatedly called for ending some pediatric shot schedules in the US so as to align more in line with Denmark, a society with universal health coverage and a population roughly the population of the state of Wisconsin.

To date public appearances, she has continued to focus on vaccines – typically the responsibility of Prasad, chief of the FDA’s CBER – rather than medication approval.

Questions Over Qualifications

The appointee has no obvious track record in medication creation, approval processes or administrative roles, which has been typical for former heads of the Center for Biologics Evaluation and Research. She has served at the FDA as a key advisor to the agency head and the vaccine center since earlier this year.

“It seems she lacks to have the requisite experience” for leading the drug-regulation department, stated Dr. Jonathan Howard. “She lacks experience running a randomized controlled trial. She is not versed in managing a major agency. She has no expertise in industry regulation.”

Previous heads of CBER would “grasp regulatory frameworks and the underlying principles of pharmaceutical innovation”, commented a former acting FDA commissioner. “Frankly, she has not acquired the kind of background that prior appointees who headed the center have had.”

CDER has an immense workload at the FDA, the former commissioner pointed out.

“The public just focuses on the novel medication approvals, but the generic program approves numerous off-brand pharmaceuticals. There is also a biosimilars program, OTC medication office and other areas, and each of these must be supervised,” Woodcock noted. “The thing you neglect, that is precisely what that I always told people is going to cause problems.”

Furthermore, a significant leadership component to the job, which oversees over 5,000 staff members. “It is a massive management job, if you perform it correctly,” the former official added.

Agency Reaction and Contentious Programs

In response to questions about Høeg’s qualifications and whether this appointment indicates increased cooperation among FDA leaders on vaccines, a press secretary responded that the “concerns are based on flawed premises”.

“Her experience is consistent with the responsibilities of her job,” the representative stated, pointing to the period Dr. Høeg spent guiding the FDA commissioner on “drug safety and approval science, including predictive safety algorithms and immunization monitoring”.

As the temporary head, Høeg takes over the commissioner’s controversial fast-track approval initiative, a contentious rapid therapy clearance system that reportedly worried her former heads. “How are these drugs being selected for this expedited pathway? Who makes the calls?” Dr. Howard questioned. “There is a lot of secrecy going on at the regulatory body right now.”

Overall, he stated, “the Food and Drug Administration looks to be trending towards less stringent oversight of most medications, with the exception of immunizations.”

Documented Past Work on Vaccines

Concerning immunizations, Dr. Høeg has a clearer, if troubling, past, some experts said. She released a analysis using unverified crowd-sourced reports to estimate the frequency of myocarditis after COVID-19 immunization. She consulted for the Florida surgeon general Joseph Ladapo, who allegedly have changed statistics to imply COVID-19 vaccines are more dangerous than they are.

Part of her “wish list” for the incoming government included revising regulations for new vaccines and halting “unnecessary” immunizations, she stated following the vote on a podcast. At the agency, Dr. Høeg has reportedly proposed excluding young men from getting Covid vaccinations.

“She’s an thorough true believer who starts off with her preconceived notions and tailors the evidence to fit the evidence in a highly deceptive, fraudulent fashion,” Howard said.

Consolidating Power and a “Campaign of Retribution”

Dr. Høeg became part of other dissenters, {like|