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Given that the US proceeds with sweeping changes to its immunization schedules, a particular individual has surfaced in a surprising turn: Høeg, a Danish American physician and public health researcher who first made her name by expressing skepticism about coronavirus shots in the pandemic and has concentrated on alleged fatalities after COVID-19 vaccination in her short position at the US Food and Drug Administration (FDA).

Proposed Changes to Pediatric Vaccine Schedule

Health officials were set to unveil radical changes to the childhood immunization program in December, aligning the US with the Danish immunization schedule, sources say – a substantial departure that would put the US out of step with many the international standard with little proof for improved outcomes. The planned update has been postponed until the new year.

In place of the top vaccines chief, Dr. Høeg is scheduled to present at the meeting. She was just designated interim head of the FDA’s drug evaluation center, the fifth appointee to run the office this year.

A New Direction at the Regulatory Body

This interim role could signify a strengthened alliance between the drug and vaccine centers as Dr. Høeg and Dr. Prasad solidify control at the regulatory agency – and it points to a renewed priority upon dismantling previously authorized immunizations at the FDA.

Dr. Høeg has repeatedly called for discontinuing certain pediatric shot schedules in the US to become more similar to Denmark's approach, a country with comprehensive healthcare and a population approximately the size of Wisconsin’s.

So far public appearances, she has continued to focus on vaccination policy – typically the purview of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of medication approval.

Concerns Over Qualifications

The appointee has no obvious experience in pharmaceutical research, approval processes or management, which has been standard for former heads of the Center for Biologics Evaluation and Research. She has worked at the FDA as a top consultant to the agency head and the vaccine center since March.

“She doesn’t seem to have any of the qualifications” for running the pharmaceutical oversight division, said Dr. Jonathan Howard. “She has not conducted a clinical trial. She is not versed in managing a major agency. She has no expertise in industry regulation.”

Past commissioners of the center would “understand legal statutes and the science of medication creation”, said Dr. Janet Woodcock. “Clearly, she doesn’t have the sort of resume that former directors who ran CBER have had.”

The drug center has an vast portfolio at the agency, Woodcock pointed out.

“The public just pays attention on the new drug program, but the off-patent medication office authorizes a multitude of generic drugs. There’s a biosimilars program, OTC medication office and more, and all of those must be supervised,” she explained. “The responsibility you overlook, that’s the thing that I always told people is going to come back to haunt you.”

Additionally, a major leadership aspect to the role, which supervises more than 5,000 employees. “It is a massive leadership role, if you do it right,” the former official said.

Agency Reaction and Controversial Programs

When asked about concerns about Dr. Høeg's credentials and whether this appointment indicates greater collaboration among agency officials on vaccines, a representative responded that the “questions rely on inaccurate presumptions”.

“Her resume matches the duties of her job,” the spokesperson said, pointing to the months Høeg spent counseling the agency head on “medication safety and approval science, including computational safety modeling and shot safety tracking”.

In her interim role, Høeg inherits the commissioner’s controversial priority voucher program, a controversial expedited medication authorization process that apparently concerned her predecessors. “How are these medications being picked for this voucher program? Who is making the choices?” Dr. Howard said. “There’s a lot of secrecy going on at the FDA right now.”

Broadly speaking, he stated, “the FDA appears to be shifting towards laxer regulations of most medications, except for vaccines.”

Documented Track Record on Vaccines

Regarding vaccines, Dr. Høeg has a more established, if problematic, past, some experts have noted. She published a research paper using unconfirmed volunteer-provided data to determine the incidence of heart inflammation after COVID-19 vaccination. She counseled the Florida top health official Joseph Ladapo, who reportedly have altered data to suggest Covid vaccines are pose a greater threat than they are.

Among her “wish list” for the incoming federal leadership included altering rules for novel immunizations and ending “unnecessary” vaccines, she remarked following the vote on a online show. At the FDA, Dr. Høeg has allegedly floated the idea of barring young men from receiving COVID-19 vaccinations.

“She’s an complete dogmatist who begins with her beliefs and works backwards to retrofit the data in a very deceptive, untruthful manner,” Howard stated.

Taking Control and a “Push for Payback”

Høeg joined fellow skeptics, {like|