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As America continues making historic changes to its vaccine schedules, an unexpected name has emerged somewhat surprisingly: Høeg, an American of Danish descent physician and epidemiologist who first made her name by expressing skepticism about COVID-19 vaccinations throughout the global health crisis and has zeroed in on possible fatalities after COVID-19 immunization in her recent time at the Food and Drug Administration.

Planned Changes to Pediatric Vaccine Schedule

Agency leaders were set to announce major revisions to the pediatric vaccination calendar in December, bringing the US with the Danish national calendar, it is understood – a substantial departure that would place the US out of step with a large portion of the global community with no evidence for benefit. The planned update has been postponed until the new year.

In place of Vinay Prasad, Dr. Høeg is scheduled to address the audience at the meeting. She was newly appointed interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to run the office this year.

Consolidating Power at the Agency

This interim role may indicate a closer partnership between the drug and biologics divisions as Høeg and Dr. Prasad strengthen their influence at the agency – and it signals a renewed priority upon dismantling long-standing vaccines at the FDA.

Dr. Høeg has frequently advocated for discontinuing specific childhood shot schedules in the US to become more in line with Denmark's approach, a society with comprehensive healthcare and a population about the size of Wisconsin’s.

To date comments, she has kept her attention on immunizations – traditionally the purview of Dr. Prasad, head of the FDA’s CBER – instead of pharmaceutical oversight.

Questions Over Background

Dr. Høeg has no apparent experience in pharmaceutical research, approval processes or leadership, which has been typical for past leaders of the Center for Biologics Evaluation and Research. She has worked at the FDA as a senior adviser to the commissioner and CBER since earlier this year.

“She appears not to have the requisite experience” for overseeing the pharmaceutical oversight division, said a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She lacks experience in managing a major agency. She has no expertise in industry regulation.”

Previous directors of CBER would “be deeply familiar with laws and regulations and the underlying principles of pharmaceutical innovation”, commented Janet Woodcock. “Objectively, she has not acquired the kind of background that previous people who headed CBER have had.”

CDER has an vast range of responsibilities at the agency, Woodcock stated.

“Everybody just pays attention on the innovative therapies, but the generic drug division authorizes a multitude of generic drugs. There is also a biosimilars program, over-the-counter program and more, and all of those must be supervised,” Woodcock noted. “The thing you overlook, that is the part that I always told people is going to come back to haunt you.”

There is also, a substantial administrative component to the position, which supervises more than 5,000 personnel. “It’s a enormous administrative position, if you perform it correctly,” the former official added.

Agency Reaction and Contentious Initiatives

When asked about questions about Dr. Høeg's credentials and whether this appointment indicates increased cooperation among FDA leaders on vaccines, a spokesperson said that the “inquiries stem from inaccurate premises”.

“This background is consistent with the functions of her job,” the official stated, pointing to the months Høeg spent advising the agency head on “drug safety and regulatory science, including predictive safety algorithms and shot safety tracking”.

In her interim role, Høeg takes over the agency head's new expedited review system, a disputed rapid medication authorization process that apparently troubled her preceding directors. “How are these drugs being chosen for this voucher program? Who is making the calls?” Howard questioned. “There is a lot of confidentiality going on at the FDA right now.”

In general, he said, “the FDA seems to be moving towards more relaxed regulations of pharmaceuticals, with the exception of immunizations.”

Documented History on Immunizations

With immunizations, Dr. Høeg has a more documented, if concerning, history, Howard observe. She published a research paper using non-validated public submissions to assess the incidence of heart inflammation following COVID-19 vaccination. She advised the Florida chief medical officer Joseph Ladapo, who was said to have modified findings to indicate Covid vaccines are pose a greater threat than they are.

Part of her “desired changes” for the incoming administration featured revising guidelines for new vaccines and ending “optional” vaccines, she said following the vote on a podcast. At the FDA, Høeg has allegedly floated the idea of preventing teenage boys from getting Covid vaccinations.

“She’s an all-around true believer who starts off with her beliefs and reverse-engineers to fit the evidence in a extremely deceptive, fraudulent fashion,” Howard argued.

Gaining Influence and a “Push for Payback”

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