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Given that the United States continues making unprecedented changes to its immunization schedules, one figure has emerged somewhat surprisingly: Høeg, a US-based physician and public health researcher who first made her name by casting doubt on COVID-19 vaccinations throughout the pandemic and has concentrated on potential deaths after Covid immunization in her brief time at the Food and Drug Administration.

Scheduled Shifts to Childhood Immunization Schedule

Public health authorities had intended to reveal major revisions to the childhood vaccine schedule in December, aligning the US with Denmark’s immunization schedule, according to reports – a substantial departure that would place the US out of alignment with much of the international standard with little proof for benefit. The planned update has been delayed until the new year.

Instead of the top vaccines chief, Dr. Høeg is set to speak at the gathering. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to lead the division this year.

A New Direction at the FDA

Høeg's temporary position could signify a strengthened alliance between the drug and biologics branches as Dr. Høeg and Dr. Prasad strengthen their influence at the agency – and it suggests a renewed priority upon reevaluating long-standing immunizations at the FDA.

Høeg has often pushed for discontinuing some childhood immunization guidelines in the US to become more like the Danish model, a country with comprehensive healthcare and a number of inhabitants roughly the size of the state of Wisconsin.

To date comments, she has persisted in emphasizing on immunizations – usually the domain of Dr. Prasad, director of the FDA’s CBER – instead of drug regulation.

Doubts Over Expertise

The appointee has no apparent track record in drug development, approval processes or leadership, which has been typical for past heads of the biologics center. She has worked at the FDA as a key advisor to the FDA chief and CBER since earlier this year.

“It seems she lacks to have the requisite experience” for overseeing the CDER, remarked Jonathan Howard. “She has not conducted a scientific study. She has no expertise in leading a sizeable institution. She lacks background in industry regulation.”

Former directors of the center would “be deeply familiar with regulatory frameworks and the research of pharmaceutical innovation”, noted Dr. Janet Woodcock. “Objectively, she has not acquired the kind of background that previous people who headed the center have had.”

The drug center has an vast portfolio at the FDA, she emphasized.

“Many people just pays attention on the innovative therapies, but the generic program approves numerous generic medications. There is also a biosimilars program, OTC medication office and other areas, and each of these have to be looked after,” Dr. Woodcock said. “The responsibility you don’t keep your eye on, that is precisely what that I always told people is going to come back to haunt you.”

There is also, a major management element to the role, which supervises more than 5,000 employees. “It is a enormous leadership role, if you do it right,” she concluded.

Response and Contentious Programs

Regarding inquiries about Høeg’s fitness for the role and whether this appointment represents greater collaboration among agency officials on vaccines, a spokesperson responded that the “inquiries are based on flawed premises”.

“Her resume is consistent with the functions of her role,” the representative explained, citing the time Dr. Høeg spent guiding the agency head on “medication safety and regulatory science, including computational safety modeling and vaccine surveillance”.

As the temporary head, Høeg takes over the agency head's recently launched priority voucher program, a contentious expedited drug-approval program that reportedly troubled her preceding directors. “How are these therapies being chosen for this voucher program? Who is making the calls?” Dr. Howard asked. “There’s a lot of lack of transparency happening at the agency right now.”

Broadly speaking, he remarked, “the Food and Drug Administration seems to be moving towards less stringent oversight of pharmaceuticals, with the exception of immunizations.”

Established Track Record on Vaccines

With immunizations, Høeg has a more established, if concerning, history, some experts observe. She published a analysis using non-validated public submissions to determine the frequency of myocarditis after Covid vaccination. She counseled the state of Florida chief medical officer Joseph Ladapo, who allegedly have changed statistics to suggest Covid vaccines are more dangerous than they are.

Part of her “policy goals” for the new federal leadership featured changing rules for new vaccines and ending “non-essential” immunizations, she stated following the vote on a podcast. At the agency, Høeg has according to sources proposed preventing young men from obtaining Covid vaccines.

“She is an thorough ideologue who commences with her preconceived notions and works backwards to fit the science in a extremely disingenuous, fraudulent way,” Howard argued.

Consolidating Power and a “Revenge Tour”

Dr. Høeg joined other skeptics, {like|