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Given that the United States proceeds with historic revisions to its immunization schedules, a particular individual appears somewhat surprisingly: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by casting doubt on COVID-19 vaccinations during the pandemic and has zeroed in on alleged fatalities following COVID-19 vaccination in her recent time at the Food and Drug Administration.

Planned Overhauls to Childhood Vaccine Program

Health officials had intended to unveil radical changes to the pediatric vaccine schedule earlier this month, bringing the US with Denmark’s national calendar, it is understood – a significant shift that would place the US out of step with much of the global community with no evidence for improved outcomes. The planned update has been delayed until the coming year.

Instead of the director of the vaccine center, Høeg is set to speak at the gathering. She was recently named temporary leader of the FDA’s drug evaluation center, the fifth appointee to head the division this calendar year.

A New Direction at the FDA

Høeg's temporary position could signify a closer partnership between the drug and vaccine branches as Dr. Høeg and Prasad strengthen their influence at the regulatory agency – and it points to a renewed priority upon dismantling previously authorized immunizations at the FDA.

The new acting director has often pushed for ending certain pediatric vaccine recommendations in the US in order to be more similar to the Danish model, a country with universal health coverage and a citizenry about the size of Wisconsin’s.

So far public appearances, she has continued to focus on vaccines – usually the domain of Dr. Prasad, chief of the FDA’s CBER – as opposed to pharmaceutical oversight.

Questions Over Background

The appointee has no apparent track record in pharmaceutical research, oversight or leadership, which has been customary for former directors of the CBER. She has worked at the FDA as a senior adviser to the FDA chief and CBER since earlier this year.

“She doesn’t seem to have the necessary background” for leading the CDER, remarked Dr. Jonathan Howard. “She’s never run a randomized controlled trial. She has no expertise in leading a major agency. She has no expertise in pharmaceutical oversight.”

Previous commissioners of the center would “understand laws and regulations and the science of drug development”, commented Janet Woodcock. “Frankly, she lacks the kind of background that previous people who headed CBER have had.”

This division has an vast range of responsibilities at the FDA, Woodcock emphasized.

“Many people just zeroes in on the innovative therapies, but the generic program clears thousands of generic medications. There’s a biosimilars division, OTC medication office and other areas, and all of those need to be looked after,” Dr. Woodcock explained. “The responsibility you don’t keep your eye on, that’s the thing that I always told people is going to cause problems.”

There is also, a major leadership element to the position, which manages in excess of 5,000 staff members. “It’s a massive leadership role, if you do it right,” the former official said.

Agency Reaction and Contentious Initiatives

When asked about inquiries about Høeg’s qualifications and whether this appointment signifies more teamwork among FDA leaders on vaccines, a spokesperson responded that the “concerns stem from incorrect premises”.

“Her resume aligns with the functions of her role,” the spokesperson said, citing the months Dr. Høeg spent guiding the agency head on “drug safety and oversight research, including computerized risk analysis and shot safety tracking”.

As the temporary head, Høeg takes over the agency head's new expedited review system, a controversial one-day drug-approval program that apparently troubled her predecessors. “How are these therapies being chosen for this expedited pathway? Who is making the calls?” Howard questioned. “There is a lot of confidentiality happening at the regulatory body right now.”

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

Public History on Vaccines

Concerning immunizations, Høeg has a clearer, if troubling, history, some experts observe. She authored a research paper using unverified public submissions to assess the rate of myocarditis after COVID-19 vaccination. She advised the state of Florida surgeon general Dr. Joseph Ladapo, who allegedly have modified findings to indicate COVID-19 vaccinations are more dangerous than they are.

Part of her “desired changes” for the current administration included changing rules for recently developed shots and discontinuing “optional” vaccines, she stated post-election on a online show. At the FDA, Dr. Høeg has according to sources floated the idea of excluding adolescent males from getting Covid vaccinations.

“She’s an all-around ideologue who commences with her beliefs and works backwards to accommodate the evidence in a highly disingenuous, fraudulent way,” Dr. Howard stated.

Taking Control and a “Revenge Tour”

Høeg became part of other dissenters, {like|