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While the US continues making historic revisions to its vaccine schedules, one figure appears in a surprising turn: Høeg, a Danish American physician and public health researcher who rose to prominence by questioning coronavirus shots during the pandemic and has zeroed in on potential deaths following COVID-19 vaccination in her short tenure at the Food and Drug Administration.

Proposed Shifts to Pediatric Immunization Schedule

Health officials had intended to reveal radical revisions to the childhood immunization program recently, aligning the US with Denmark’s national calendar, according to reports – a substantial departure that would put the US out of alignment with a large portion of the world with no evidence for public health gain. The planned update has been delayed until the new year.

In place of the top vaccines chief, Høeg is set to address the audience at the meeting. She was newly appointed interim head of the FDA’s CDER, the fifth individual to lead the division this calendar year.

A Shift at the FDA

The acting appointment may indicate a strengthened alliance between the pharmaceutical and biologics divisions as Høeg and Prasad solidify control at the FDA – and it suggests a greater focus upon dismantling long-standing immunizations at the FDA.

The new acting director has frequently advocated for discontinuing certain childhood vaccine recommendations in the US to become more in line with the Danish model, a country with comprehensive healthcare and a citizenry about the population of the state of Wisconsin.

In her initial statements, she has kept her attention on vaccines – traditionally the purview of Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than pharmaceutical oversight.

Concerns Over Expertise

Dr. Høeg has no apparent experience in pharmaceutical research, oversight or administrative roles, which has been typical for former leaders of the biologics center. She has been employed at the FDA as a senior adviser to the FDA chief and the vaccine center since spring.

“She doesn’t seem to have the necessary background” for running the pharmaceutical oversight division, stated Jonathan Howard. “She lacks experience running a clinical trial. She has no expertise in running a sizeable institution. She lacks background in drug approvals.”

Past commissioners of the center would “be deeply familiar with regulatory frameworks and the science of medication creation”, said Janet Woodcock. “Frankly, she doesn’t have the type of experience that former directors who headed CBER have had.”

The drug center has an enormous range of responsibilities at the FDA, Woodcock emphasized.

“Many people just zeroes in on the innovative therapies, but the generic drug division approves a multitude of generic drugs. There is also a biosimilars division, non-prescription drug unit and more, and each of these must be managed,” Dr. Woodcock said. “The thing you neglect, that’s the thing that I always told people is going to come back to haunt you.”

Furthermore, a major administrative aspect to the role, which manages in excess of 5,000 employees. “It is a enormous leadership role, if you do it right,” she added.

Agency Reaction and Controversial Programs

Regarding questions about Høeg’s fitness for the role and whether this assignment represents more teamwork among regulatory chiefs on vaccines, a spokesperson responded that the “concerns rely on inaccurate premises”.

“Her resume aligns with the duties of her position,” the spokesperson explained, pointing to the time Dr. Høeg spent counseling the FDA commissioner on “pharmaceutical safety and approval science, including computerized risk analysis and vaccine surveillance”.

As acting director, Høeg assumes responsibility for the agency head's recently launched priority voucher program, a controversial rapid drug-approval program that apparently troubled her predecessors. “By what process are these drugs being selected for this fast-track system? Who is making the decisions?” Howard said. “There is a lot of lack of transparency going on at the FDA right now.”

Overall, he remarked, “the agency appears to be shifting towards more relaxed oversight of all drugs, except for immunizations.”

Documented Track Record on Immunizations

Regarding immunizations, Dr. Høeg has a more documented, if concerning, track record, critics observe. She authored a research paper using unconfirmed public submissions to determine the rate of heart inflammation following COVID-19 vaccination. She advised the Florida top health official Joseph Ladapo, who allegedly have altered data to imply COVID-19 vaccines are riskier than they are.

Included in her “policy goals” for the new federal leadership included revising guidelines for recently developed shots and ending “unnecessary” immunizations, she said after the election on a online show. At the FDA, Dr. Høeg has reportedly proposed preventing teenage boys from getting COVID-19 vaccines.

“She’s an complete dogmatist who starts off with her conclusions and tailors the evidence to fit the evidence in a very disingenuous, fraudulent fashion,” Dr. Howard said.

Consolidating Power and a “Campaign of Retribution”

Høeg became part of fellow skeptics, {like|