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While America proceeds with unprecedented changes to its immunization recommendations, an unexpected name has emerged in a surprising turn: Høeg, an American of Danish descent sports physician and public health researcher who first made her name by questioning COVID-19 shots throughout the pandemic and has focused upon possible deaths after COVID-19 vaccination in her brief tenure at the FDA.

Proposed Overhauls to Childhood Immunization Program

Public health authorities had intended to reveal sweeping changes to the childhood immunization program in December, synchronizing the US with the Danish national calendar, according to reports – a significant shift that would put the US out of step with a large portion of the international standard with little proof for improved outcomes. This reveal has been postponed until the new year.

In place of Vinay Prasad, Dr. Høeg is set to address the audience at the meeting. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to head the center this year.

A Shift at the Regulatory Body

The acting appointment could signify a tighter collaboration between the pharmaceutical and vaccine divisions as Dr. Høeg and Prasad consolidate power at the FDA – and it signals a greater focus upon reevaluating already-approved immunizations at the FDA.

The new acting director has frequently advocated for discontinuing specific pediatric vaccine recommendations in the US so as to align more in line with the Danish model, a country with comprehensive healthcare and a citizenry roughly the size of the state of Wisconsin.

So far public appearances, she has kept her attention on immunizations – typically the responsibility of Dr. Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to pharmaceutical oversight.

Questions Over Background

Dr. Høeg has no obvious experience in drug development, approval processes or management, which has been standard for former directors of the CBER. She has served at the FDA as a key advisor to the agency head and the vaccine center since earlier this year.

“She doesn’t seem to have the necessary background” for leading the drug-regulation department, stated Jonathan Howard. “She lacks experience running a clinical trial. She lacks experience in managing a major agency. She is not an expert in drug approvals.”

Past commissioners of the center would “be deeply familiar with legal statutes and the underlying principles of drug development”, said Dr. Janet Woodcock. “Objectively, she has not acquired the sort of resume that former directors who headed the center have had.”

CDER has an immense portfolio at the agency, Woodcock pointed out.

“Many people just pays attention on the new drug program, but the off-patent medication office authorizes a multitude of off-brand pharmaceuticals. There is also a biologic copycat branch, OTC medication office and more, and every single one have to be managed,” Woodcock said. “The thing 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 substantial administrative component to the job, which oversees over 5,000 personnel. “It’s a enormous management job, if you perform it correctly,” she concluded.

Official Statement and Controversial Initiatives

In response to inquiries about Dr. Høeg's fitness for the role and whether this selection represents greater collaboration among FDA leaders on immunizations, a spokesperson stated that the “questions stem from incorrect assumptions”.

“This background aligns with the duties of her position,” the spokesperson said, pointing to the months Høeg spent counseling the agency head on “pharmaceutical safety and regulatory science, including computerized risk analysis and shot safety tracking”.

In her interim role, Høeg takes over the agency head's controversial fast-track approval initiative, a contentious expedited medication authorization process that allegedly troubled her former heads. “How are these drugs being chosen for this expedited pathway? Who is making the choices?” Howard said. “There’s a lot of confidentiality going on at the agency right now.”

Broadly speaking, he remarked, “the Food and Drug Administration looks to be trending towards less stringent oversight of all drugs, with the exception of shots.”

Established Track Record on Immunizations

Regarding vaccines, Dr. Høeg has a more documented, if problematic, past, critics observe. She released a analysis using non-validated public submissions to estimate the incidence of heart inflammation following Covid immunization. She advised the Florida surgeon general Joseph Ladapo, who was said to have modified findings to suggest COVID-19 vaccinations are riskier than they are.

Among her “policy goals” for the incoming government included altering regulations for novel immunizations and discontinuing “optional” vaccines, she remarked post-election on a audio program. At the FDA, Dr. Høeg has allegedly floated the idea of barring adolescent males from obtaining Covid vaccines.

“She is an all-around dogmatist who starts off with her conclusions and tailors the evidence to accommodate the science in a extremely disingenuous, dishonest way,” Dr. Howard said.

Consolidating Power and a “Push for Payback”

Dr. Høeg aligned with other contrarians, {like|