🔗 Share this article

While the US undertakes unprecedented revisions to its vaccination recommendations, an unexpected name has emerged in a surprising turn: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by questioning coronavirus vaccinations during the pandemic and has concentrated on possible deaths after COVID-19 immunization in her brief position at the FDA.

Planned Shifts to Pediatric Vaccine Schedule

Health officials planned to announce major revisions to the pediatric immunization program earlier this month, bringing the US with Denmark’s immunization schedule, sources say – a major change that would place the US at odds with much of the global community with little proof for improved outcomes. The planned update has been pushed back until the coming year.

In place of the director of the vaccine center, Høeg is scheduled to address the audience at the gathering. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to run the center this calendar year.

A Shift at the FDA

Høeg's temporary position may indicate a tighter collaboration between the pharmaceutical and biologics branches as Høeg and Dr. Prasad solidify control at the agency – and it suggests a greater focus upon dismantling already-approved immunizations at the FDA.

Høeg has frequently advocated for halting some pediatric vaccine recommendations in the US to become more similar to Denmark, a nation with universal health coverage and a number of inhabitants approximately the population of Wisconsin’s.

To date public appearances, she has continued to focus on immunizations – traditionally the domain of Dr. Prasad, chief of the FDA’s vaccine center – rather than medication approval.

Questions Over Qualifications

Høeg has no obvious track record in pharmaceutical research, oversight or management, which has been customary for past leaders of the CBER. She has worked at the FDA as a top consultant to the commissioner and CBER since March.

“She appears not to have the requisite experience” for running the pharmaceutical oversight division, said Dr. Jonathan Howard. “She has not conducted a randomized controlled trial. She has no expertise in running a sizeable institution. She is not an expert in pharmaceutical oversight.”

Past heads of the center would “be deeply familiar with legal statutes and the research of pharmaceutical innovation”, noted Dr. Janet Woodcock. “Frankly, she has not acquired the kind of background that former directors who ran CBER have had.”

The drug center has an vast range of responsibilities at the agency, she pointed out.

“Everybody just zeroes in on the new drug program, but the generic program clears thousands of generic medications. There is also a biosimilars division, over-the-counter program and more, and each of these must be supervised,” Dr. Woodcock said. “The thing you overlook, that is precisely what that I always told people is going to cause problems.”

Furthermore, a significant administrative component to the job, which manages more than 5,000 personnel. “It is a huge leadership role, if you do it right,” Woodcock concluded.

Agency Reaction and Disputed Programs

When asked about concerns about Dr. Høeg's qualifications and whether this appointment signifies more teamwork among regulatory chiefs on vaccines, a representative responded that the “inquiries are based on inaccurate presumptions”.

“This background aligns with the functions of her role,” the representative explained, noting the period Høeg spent advising the agency head on “pharmaceutical safety and approval science, including computerized risk analysis and immunization monitoring”.

As acting director, Høeg assumes responsibility for the commissioner’s controversial fast-track approval initiative, a contentious rapid drug-approval program that reportedly concerned her preceding directors. “By what process are these drugs being chosen for this expedited pathway? Who takes the choices?” Dr. Howard questioned. “There’s a lot of lack of transparency going on at the FDA right now.”

Broadly speaking, he said, “the agency appears to be shifting towards less stringent oversight of all drugs, except for shots.”

Public Past Work on Vaccines

With vaccines, Dr. Høeg has a more established, if troubling, history, Howard have noted. She released a study using unverified crowd-sourced reports to determine the frequency of myocarditis after COVID-19 vaccination. She advised the state of Florida top health official Joseph Ladapo, who was said to have modified findings to indicate COVID-19 vaccines are more dangerous than they are.

Part of her “desired changes” for the current government included revising guidelines for novel immunizations and halting “unnecessary” vaccines, she stated post-election on a online show. At the agency, Dr. Høeg has allegedly floated the idea of barring teenage boys from receiving Covid vaccines.

“She is an thorough ideologue who begins with her beliefs and reverse-engineers to fit the evidence in a highly disingenuous, untruthful way,” Howard argued.

Consolidating Power and a “Push for Payback”

Høeg aligned with other contrarians, {like|