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As the US continues making unprecedented revisions to its immunization guidelines, a particular individual has emerged in a surprising turn: Høeg, a Danish American sports physician and epidemiologist who initially gained attention by expressing skepticism about coronavirus shots in the pandemic and has concentrated on alleged deaths following Covid immunization in her brief tenure at the Food and Drug Administration.

Scheduled Changes to Childhood Immunization Schedule

Health officials had intended to reveal major changes to the childhood vaccine schedule recently, aligning the US with Denmark’s national calendar, it is understood – a significant shift that would put the US out of alignment with much of the global community with no evidence for public health gain. The planned update has been delayed until the coming year.

Rather than Vinay Prasad, Dr. Høeg is listed to address the audience at the gathering. She was recently named interim head of the FDA’s CDER, the fifth person to head the office this year.

A Shift at the Regulatory Body

The acting appointment might represent a closer partnership between the drug and biologics centers as Høeg and Dr. Prasad solidify control at the agency – and it suggests a renewed priority upon rolling back long-standing immunizations at the FDA.

Dr. Høeg has often pushed for discontinuing some pediatric vaccine recommendations in the US to become more similar to Denmark, a country with nationalized medicine and a number of inhabitants roughly the population of the state of Wisconsin.

So far public appearances, she has kept her attention on immunizations – typically the purview of Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than medication approval.

Concerns Over Qualifications

Dr. Høeg has no apparent track record in pharmaceutical research, oversight or leadership, which has been customary for former leaders of the CBER. She has been employed at the FDA as a key advisor to the FDA chief and the vaccine center since earlier this year.

“She doesn’t seem to have any of the qualifications” for leading the CDER, said a neurologist and psychiatrist. “She’s never run a clinical trial. She has no expertise in managing a sizeable institution. She is not an expert in drug approvals.”

Past commissioners of the center would “grasp laws and regulations and the underlying principles of medication creation”, said a former acting FDA commissioner. “Clearly, she doesn’t have the sort of resume that prior appointees who headed the center have had.”

CDER has an enormous range of responsibilities at the FDA, Woodcock pointed out.

“Everybody just zeroes in on the new drug program, but the off-patent medication office clears numerous off-brand pharmaceuticals. There is also a biosimilars division, over-the-counter program and so forth, and all of those must be supervised,” Dr. Woodcock said. “The thing you don’t keep your eye on, that is the part that I always told people is going to bite you.”

Furthermore, a significant administrative element to the job, which manages more than 5,000 personnel. “It’s a huge management job, if you execute it properly,” the former official concluded.

Official Statement and Contentious Initiatives

In response to concerns about Høeg’s fitness for the role and whether this selection represents greater collaboration among regulatory chiefs on immunizations, a press secretary said that the “questions are based on flawed assumptions”.

“Her experience aligns with the functions of her job,” the representative said, noting the period Dr. Høeg spent guiding the agency head on “pharmaceutical safety and regulatory science, including predictive safety algorithms and vaccine surveillance”.

In her interim role, Høeg takes over the agency head's new expedited review system, a controversial rapid medication authorization process that apparently worried her preceding directors. “How are these therapies being picked for this fast-track system? Who is making the decisions?” Howard said. “There is a lot of secrecy going on at the FDA right now.”

In general, he remarked, “the FDA appears to be shifting towards laxer oversight of most medications, with the exception of shots.”

Established Past Work on Immunizations

Regarding vaccines, Dr. Høeg has a more established, if problematic, past, critics said. She released a study using unconfirmed crowd-sourced reports to determine the incidence of myocarditis after Covid vaccination. She counseled the Florida chief medical officer Joseph Ladapo, who was said to have modified findings to indicate COVID-19 vaccinations are more dangerous than they are.

Part of her “policy goals” for the current government featured revising rules for new vaccines and ending “non-essential” vaccines, she remarked post-election on a online show. At the agency, Dr. Høeg has reportedly floated the idea of excluding teenage boys from receiving COVID-19 vaccinations.

“She’s an thorough true believer who starts off with her beliefs and works backwards to accommodate the data in a highly misleading, fraudulent manner,” Howard stated.

Consolidating Power and a “Push for Payback”

Høeg became part of other dissenters, {like|