🔗 Share this article

As the US proceeds with unprecedented revisions to its vaccination schedules, an unexpected name has emerged unexpectedly: Høeg, a Danish American physician and public health researcher who initially gained attention by casting doubt on COVID-19 vaccines during the pandemic and has focused upon alleged fatalities after Covid vaccination in her recent position at the US Food and Drug Administration (FDA).

Proposed Changes to Childhood Immunization Schedule

Agency leaders planned to unveil major changes to the pediatric vaccine schedule in December, synchronizing the US with Denmark’s immunization schedule, it is understood – a substantial departure that would put the US out of step with a large portion of the world with little proof for benefit. This reveal has been delayed until the new year.

Rather than the director of the vaccine center, Dr. Høeg is listed to address the audience at the gathering. She was recently named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to head the division this calendar year.

A Shift at the Regulatory Body

Høeg's temporary position might represent a closer partnership between the drug and biologics branches as Dr. Høeg and Prasad solidify control at the FDA – and it signals a renewed priority upon dismantling previously authorized vaccines at the FDA.

The new acting director has repeatedly called for ending certain childhood shot schedules in the US in order to be more in line with the Danish model, a society with comprehensive healthcare and a population about the population of Wisconsin’s.

So far comments, she has kept her attention on vaccines – typically the responsibility of Dr. Prasad, head of the FDA’s CBER – instead of medication approval.

Questions Over Background

Dr. Høeg has little discernible background in pharmaceutical research, oversight or management, which has been typical for previous leaders of the Center for Biologics Evaluation and Research. She has served at the FDA as a senior adviser to the agency head and CBER since earlier this year.

“She appears not to have the requisite experience” for leading the drug-regulation department, said a neurologist and psychiatrist. “She lacks experience running a scientific study. She has no expertise in managing a major agency. She lacks background in pharmaceutical oversight.”

Previous directors of the center would “be deeply familiar with regulatory frameworks and the underlying principles of drug development”, said Janet Woodcock. “Objectively, she has not acquired the kind of background that prior appointees who led CBER have had.”

This division has an enormous portfolio at the agency, Woodcock emphasized.

“Everybody just pays attention on the new drug program, but the generic drug division authorizes thousands of off-brand pharmaceuticals. There’s a biosimilars program, non-prescription drug unit and more, and all of those need to be looked after,” Woodcock said. “The area 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 substantial administrative element to the job, which supervises more than 5,000 personnel. “It’s a huge leadership role, if you perform it correctly,” she added.

Official Statement and Controversial Programs

Regarding inquiries about Høeg’s credentials and whether this assignment represents more teamwork among regulatory chiefs on vaccines, a representative stated that the “questions are based on incorrect premises”.

“Her resume matches the duties of her role,” the spokesperson explained, noting the period Dr. Høeg spent counseling the FDA commissioner on “pharmaceutical safety and oversight research, including computerized risk analysis and vaccine surveillance”.

In her interim role, Dr. Høeg assumes responsibility for the commissioner’s controversial priority voucher program, a contentious rapid drug-approval program that allegedly worried her former heads. “By what process are these drugs being chosen for this voucher program? Who is making the decisions?” Dr. Howard questioned. “There is a lot of secrecy happening at the FDA right now.”

Broadly speaking, he said, “the Food and Drug Administration looks to be trending towards laxer rules of most medications, with the exception of vaccines.”

Public History on Immunizations

Regarding immunizations, Høeg has a more documented, if problematic, history, critics observe. She released a study using non-validated crowd-sourced reports to assess the rate of myocarditis following Covid vaccination. She advised the Florida surgeon general Dr. Joseph Ladapo, who was said to have changed statistics to indicate Covid vaccinations are pose a greater threat than they are.

Included in her “policy goals” for the current federal leadership featured changing rules for recently developed shots and ending “unnecessary” vaccines, she said post-election on a online show. At the FDA, Høeg has allegedly floated the idea of excluding teenage boys from getting Covid vaccinations.

“She is an complete dogmatist who starts off with her preconceived notions and works backwards to fit the evidence in a very disingenuous, fraudulent manner,” Howard stated.

Consolidating Power and a “Campaign of Retribution”

Høeg became part of other dissenters, {like|