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Given that the United States proceeds with sweeping changes to its immunization recommendations, a particular individual has surfaced in a surprising turn: Høeg, a Danish American physician and epidemiologist who first made her name by questioning COVID-19 vaccines during the pandemic and has zeroed in on possible deaths following Covid immunization in her recent time at the Food and Drug Administration.

Scheduled Changes to Childhood Vaccine Program

Public health authorities had intended to unveil major changes to the childhood vaccine schedule in December, bringing the US with Denmark’s national calendar, it is understood – a substantial departure that would place the US out of alignment with much of the world with insufficient data for improved outcomes. The announcement has been pushed back until the new year.

Instead of the top vaccines chief, Høeg is listed to address the audience at the gathering. She was just designated acting director of the FDA’s CDER, the fifth person to head the division this calendar year.

A Shift at the Regulatory Body

The acting appointment may indicate a tighter collaboration between the pharmaceutical and vaccine divisions as Høeg and Dr. Prasad strengthen their influence at the agency – and it points to a greater focus upon rolling back long-standing immunizations at the FDA.

Høeg has often pushed for ending some pediatric shot schedules in the US to become more similar to the Danish model, a society with nationalized medicine and a population about the population of the state of Wisconsin.

In her initial statements, she has persisted in emphasizing on immunizations – typically the purview of Prasad, chief of the FDA’s CBER – rather than pharmaceutical oversight.

Concerns Over Background

Dr. Høeg has little discernible track record in pharmaceutical research, oversight or administrative roles, which has been standard for former heads of the biologics center. She has served at the FDA as a top consultant to the FDA chief and the vaccine center since spring.

“She doesn’t seem to have the necessary background” for running the pharmaceutical oversight division, remarked Dr. Jonathan Howard. “She has not conducted a randomized controlled trial. She lacks experience in managing a sizeable institution. She is not an expert in drug approvals.”

Previous directors of the center would “understand legal statutes and the research of medication creation”, commented a former acting FDA commissioner. “Objectively, she doesn’t have the kind of background that former directors who ran CBER have had.”

This division has an enormous workload at the FDA, the former commissioner pointed out.

“The public just focuses on the new drug program, but the generic drug division authorizes thousands of generic medications. There is also a biosimilars program, over-the-counter program and more, and all of those must be looked after,” Dr. Woodcock explained. “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 major administrative element to the position, which supervises in excess of 5,000 employees. “It’s a massive leadership role, if you execute it properly,” the former official concluded.

Official Statement and Disputed Programs

When asked about questions about Høeg’s qualifications and whether this appointment represents more teamwork among FDA leaders on immunizations, a spokesperson stated that the “questions are based on inaccurate assumptions”.

“This background matches the responsibilities of her position,” the representative stated, citing the time Dr. Høeg spent guiding the FDA commissioner on “drug safety and oversight research, including computational safety modeling and immunization monitoring”.

As acting director, Dr. Høeg assumes responsibility for the agency head's recently launched priority voucher program, a controversial rapid therapy clearance system that reportedly concerned her former heads. “By what process are these therapies being picked for this voucher program? Who takes the decisions?” Howard questioned. “There’s a lot of confidentiality occurring at the regulatory body right now.”

In general, he remarked, “the agency looks to be trending towards less stringent regulations of most medications, except for shots.”

Established Past Work on Immunizations

With immunizations, Høeg has a more established, if concerning, history, some experts observe. She released a study using unverified public submissions to assess the rate of heart inflammation after Covid vaccination. She consulted for the state of Florida surgeon general Joseph Ladapo, who was said to have altered data to indicate Covid vaccines are riskier than they are.

Part of her “policy goals” for the incoming federal leadership encompassed changing rules for novel immunizations and discontinuing “optional” vaccines, she stated after the election on a online show. At the agency, Høeg has allegedly floated the idea of barring young men from getting Covid vaccinations.

“She’s an thorough true believer who commences with her conclusions and tailors the evidence to retrofit the data in a highly disingenuous, untruthful manner,” Dr. Howard argued.

Gaining Influence and a “Push for Payback”

Dr. Høeg aligned with fellow contrarians, {like|