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While the United States continues making sweeping revisions to its vaccine guidelines, an unexpected name has surfaced somewhat surprisingly: Høeg, a Danish American sports physician and public health researcher who first made her name by casting doubt on coronavirus vaccinations during the global health crisis and has concentrated on potential deaths following COVID-19 vaccination in her short position at the US Food and Drug Administration (FDA).

Proposed Shifts to Pediatric Vaccine Schedule

Health officials planned to reveal radical revisions to the pediatric vaccine schedule in December, aligning the US with the Danish national calendar, sources say – a significant shift that would place the US out of alignment with much of the global community with little proof for improved outcomes. This reveal has been postponed until the coming year.

Rather than Vinay Prasad, Dr. Høeg is scheduled to address the audience at the meeting. She was just designated interim head of the FDA’s CDER, the fifth individual to head the office this calendar year.

A New Direction at the FDA

The acting appointment might represent a closer partnership between the pharmaceutical and biologics divisions as Dr. Høeg and Prasad solidify control at the regulatory agency – and it suggests a renewed priority upon dismantling long-standing immunizations at the FDA.

The new acting director has frequently advocated for halting some pediatric vaccine recommendations in the US so as to align more in line with Denmark's approach, a society with universal health coverage and a number of inhabitants about the size of the state of Wisconsin.

To date statements, she has persisted in emphasizing on immunizations – typically the purview of Prasad, head of the FDA’s vaccine center – rather than drug regulation.

Questions Over Expertise

The appointee has no apparent experience in medication creation, approval processes or management, which has been typical for past heads of the biologics center. She has been employed at the FDA as a key advisor to the FDA chief and CBER since March.

“She appears not to have the requisite experience” for overseeing the CDER, remarked a neurologist and psychiatrist. “She lacks experience running a randomized controlled trial. She has no expertise in leading a major agency. She is not an expert in industry regulation.”

Former heads of the center would “be deeply familiar with regulatory frameworks and the research of pharmaceutical innovation”, commented Janet Woodcock. “Objectively, she has not acquired the kind of background that prior appointees who headed the center have had.”

The drug center has an enormous range of responsibilities at the FDA, the former commissioner stated.

“Everybody just focuses on the innovative therapies, but the generic drug division authorizes a multitude of generic medications. There is also a biosimilars program, over-the-counter program and so forth, and each of these must be managed,” Dr. Woodcock said. “The area you don’t keep your eye on, that’s the thing that I always told people is going to bite you.”

There is also, a significant administrative component to the job, which oversees over 5,000 staff members. “It is a huge leadership role, if you perform it correctly,” Woodcock added.

Agency Reaction and Contentious Programs

When asked about inquiries about Høeg’s qualifications and whether this selection represents increased cooperation among regulatory chiefs on vaccines, a spokesperson responded that the “inquiries stem from incorrect premises”.

“This background matches the duties of her position,” the official stated, pointing to the time Høeg spent counseling the agency head on “pharmaceutical safety and regulatory science, including computerized risk analysis and immunization monitoring”.

As acting director, Høeg inherits the agency head's new expedited review system, a controversial one-day medication authorization process that apparently concerned her preceding directors. “By what process are these medications being picked for this fast-track system? Who makes the decisions?” Howard said. “There is a lot of lack of transparency going on at the regulatory body right now.”

Broadly speaking, he said, “the agency appears to be shifting towards more relaxed regulations of all drugs, except for shots.”

Established History on Vaccines

With vaccines, Høeg has a more documented, if concerning, history, some experts said. She published a research paper using unconfirmed crowd-sourced reports to estimate the rate of myocarditis following COVID-19 vaccination. She advised the state of Florida chief medical officer Dr. Joseph Ladapo, who allegedly have modified findings to imply COVID-19 vaccines are more dangerous than they are.

Among her “policy goals” for the new administration featured revising regulations for recently developed shots and ending “unnecessary” vaccines, she said after the election on a audio program. At the FDA, Høeg has reportedly suggested preventing adolescent males from getting Covid vaccinations.

“She’s an complete dogmatist who starts off with her beliefs and works backwards to retrofit the science in a very misleading, dishonest way,” Dr. Howard stated.

Consolidating Power and a “Push for Payback”

Dr. Høeg joined fellow contrarians, {like|