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While the US undertakes historic revisions to its vaccination guidelines, an unexpected name has surfaced unexpectedly: Høeg, a Danish American physician and public health researcher who initially gained attention by expressing skepticism about COVID-19 vaccines throughout the global health crisis and has zeroed in on possible fatalities following Covid vaccination in her recent tenure at the US Food and Drug Administration (FDA).

Proposed Overhauls to Pediatric Immunization Schedule

Public health authorities had intended to announce major changes to the pediatric vaccine schedule earlier this month, aligning the US with Denmark’s national calendar, sources say – a major change that would put the US out of step with much of the international standard with insufficient data for public health gain. This reveal has been delayed until the coming year.

Rather than Vinay Prasad, Høeg is scheduled to speak at the event. She was recently named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to lead the center this calendar year.

A Shift at the Agency

The acting appointment may indicate a tighter collaboration between the pharmaceutical and vaccine divisions as Dr. Høeg and Prasad solidify control at the FDA – and it signals a greater focus upon dismantling already-approved vaccines at the FDA.

Høeg has repeatedly called for halting specific pediatric immunization guidelines in the US so as to align more in line with Denmark, a country with comprehensive healthcare and a citizenry approximately the size of Wisconsin’s.

So far public appearances, she has continued to focus on vaccination policy – usually the purview of Dr. Prasad, director of the FDA’s vaccine center – rather than pharmaceutical oversight.

Concerns Over Qualifications

Dr. Høeg has no apparent track record in drug development, regulation or leadership, which has been typical for former leaders of the biologics center. She has been employed at the FDA as a key advisor to the commissioner and CBER since spring.

“She doesn’t seem to have the requisite experience” for running the CDER, remarked a neurologist and psychiatrist. “She has not conducted a scientific study. She has no expertise in managing a sizeable institution. She lacks background in drug approvals.”

Past commissioners of the center would “understand regulatory frameworks and the research of medication creation”, commented a former acting FDA commissioner. “Objectively, she doesn’t have the type of experience that prior appointees who led the center have had.”

This division has an immense range of responsibilities at the agency, she stated.

“The public just pays attention on the innovative therapies, but the generic program clears a multitude of generic medications. There’s a biosimilars division, non-prescription drug unit and so forth, and all of those must be supervised,” Dr. Woodcock explained. “The responsibility you don’t keep your eye on, that is the part that I always told people is going to come back to haunt you.”

Furthermore, a substantial leadership aspect to the role, which manages more than 5,000 employees. “It’s a massive leadership role, if you do it right,” Woodcock said.

Agency Reaction and Contentious Policies

Regarding concerns about Høeg’s credentials and whether this selection represents increased cooperation among regulatory chiefs on immunizations, a press secretary said that the “inquiries are based on incorrect presumptions”.

“This background aligns with the functions of her position,” the official explained, citing the time Høeg spent counseling the FDA commissioner on “pharmaceutical safety and regulatory science, including computerized risk analysis and vaccine surveillance”.

As acting director, Høeg inherits the agency head's controversial fast-track approval initiative, a controversial rapid drug-approval program that reportedly troubled her former heads. “How are these drugs being selected for this fast-track system? Who makes the calls?” Dr. Howard questioned. “There is a lot of secrecy going on at the FDA right now.”

Broadly speaking, he said, “the FDA appears to be shifting towards more relaxed rules of all drugs, with the exception of shots.”

Established Track Record on Vaccines

Concerning vaccines, Høeg has a more established, if concerning, history, critics have noted. She released a study using unverified public submissions to estimate the frequency of heart inflammation after COVID-19 immunization. She advised the Florida top health official Dr. Joseph Ladapo, who reportedly have changed statistics to imply Covid vaccinations are riskier than they are.

Part of her “desired changes” for the incoming government featured revising regulations for recently developed shots and ending “unnecessary” vaccines, she said after the election on a podcast. At the agency, Høeg has allegedly suggested barring adolescent males from receiving COVID-19 vaccines.

“She’s an thorough true believer who starts off with her conclusions and tailors the evidence to accommodate the evidence in a highly misleading, untruthful way,” Howard said.

Taking Control and a “Push for Payback”

Dr. Høeg joined fellow contrarians, {like|