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Given that America proceeds with unprecedented adjustments to its immunization recommendations, a particular individual has surfaced somewhat surprisingly: Høeg, a Danish American sports physician and public health researcher who first made her name by expressing skepticism about COVID-19 vaccines in the global health crisis and has focused upon possible deaths following Covid immunization in her short position at the FDA.

Proposed Changes to Pediatric Immunization Schedule

Public health authorities planned to unveil sweeping revisions to the pediatric vaccine schedule earlier this month, synchronizing the US with Denmark’s national calendar, according to reports – a major change that would place the US out of alignment with a large portion of the international standard with little proof for improved outcomes. The planned update has been pushed back until the coming year.

Rather than Vinay Prasad, Høeg is set to speak at the event. She was just designated temporary leader of the FDA’s drug evaluation center, the fifth individual to run the office this calendar year.

Consolidating Power at the Agency

Høeg's temporary position may indicate a tighter collaboration between the drug and biologics divisions as Høeg and Prasad consolidate power at the FDA – and it signals a renewed priority upon dismantling long-standing vaccines at the FDA.

Høeg has repeatedly called for halting specific childhood vaccine recommendations in the US so as to align more similar to Denmark, a country with nationalized medicine and a citizenry about the size of Wisconsin’s.

So far statements, she has kept her attention on immunizations – usually the domain of Dr. Prasad, director of the FDA’s vaccine center – rather than medication approval.

Concerns Over Background

Høeg has little discernible experience in medication creation, regulation or leadership, which has been standard for previous leaders of the CBER. She has worked at the FDA as a key advisor to the FDA chief and the vaccine center since spring.

“She doesn’t seem to have any of the qualifications” for overseeing the CDER, remarked Dr. Jonathan Howard. “She’s never run a scientific study. She lacks experience in leading a sizeable institution. She lacks background in industry regulation.”

Previous heads of the center would “be deeply familiar with laws and regulations and the underlying principles of medication creation”, noted a former acting FDA commissioner. “Frankly, she has not acquired the kind of background that former directors who headed the center have had.”

CDER has an enormous range of responsibilities at the agency, she emphasized.

“The public just pays attention on the new drug program, but the generic drug division authorizes a multitude of generic drugs. There’s a biosimilars division, OTC medication office and so forth, and every single one need to be supervised,” she said. “The area 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 major leadership component to the job, which supervises in excess of 5,000 employees. “It’s a massive management job, if you execute it properly,” she concluded.

Response and Disputed Programs

In response to concerns about Dr. Høeg's fitness for the role and whether this selection indicates greater collaboration among agency officials on immunizations, a press secretary responded that the “concerns stem from incorrect presumptions”.

“This background matches the functions of her job,” the spokesperson explained, noting the time Høeg spent guiding the FDA commissioner on “pharmaceutical safety and regulatory science, including computerized risk analysis and vaccine surveillance”.

As the temporary head, Høeg assumes responsibility for the commissioner’s new priority voucher program, a controversial one-day medication authorization process that allegedly concerned her preceding directors. “How are these therapies being selected for this voucher program? Who makes the decisions?” Dr. Howard asked. “There is a lot of confidentiality happening at the regulatory body right now.”

Broadly speaking, he remarked, “the agency looks to be trending towards laxer regulations of most medications, aside from vaccines.”

Established History on Immunizations

With vaccines, Høeg has a more established, if troubling, track record, critics have noted. She released a study using unconfirmed public submissions to assess the incidence of heart inflammation following Covid immunization. She counseled the state of Florida top health official Joseph Ladapo, who reportedly have modified findings to indicate Covid vaccines are more dangerous than they are.

Included in her “desired changes” for the current administration featured changing rules for new vaccines and ending “unnecessary” immunizations, she said post-election on a podcast. At the FDA, Høeg has according to sources proposed excluding teenage boys from receiving COVID-19 vaccinations.

“She’s an complete true believer who starts off with her preconceived notions and reverse-engineers to retrofit the science in a highly disingenuous, fraudulent way,” Howard argued.

Consolidating Power and a “Campaign of Retribution”

Høeg joined other skeptics, {like|