🔗 Share this article

As the United States proceeds with historic revisions to its immunization recommendations, a particular individual has surfaced somewhat surprisingly: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by casting doubt on COVID-19 vaccines in the global health crisis and has focused upon potential fatalities following Covid vaccination in her recent time at the US Food and Drug Administration (FDA).

Planned Changes to Childhood Immunization Program

Agency leaders had intended to announce sweeping changes to the pediatric vaccine schedule in December, synchronizing the US with Denmark’s immunization schedule, sources say – a substantial departure that would put the US at odds with much of the world with no evidence for improved outcomes. The announcement has been delayed until the coming year.

Instead of the top vaccines chief, Dr. Høeg is listed to speak at the gathering. She was newly appointed acting director of the FDA’s drug evaluation center, the fifth appointee to head the division this calendar year.

Consolidating Power at the FDA

The acting appointment may indicate a closer partnership between the drug and vaccine divisions as Høeg and Prasad strengthen their influence at the agency – and it points to a greater focus upon rolling back already-approved immunizations at the FDA.

Dr. Høeg has repeatedly called for ending specific pediatric vaccine recommendations in the US in order to be more like Denmark's approach, a society with universal health coverage and a citizenry about the population of the state of Wisconsin.

So far public appearances, she has persisted in emphasizing on immunizations – typically the domain of Prasad, chief of the FDA’s CBER – instead of pharmaceutical oversight.

Concerns Over Background

Høeg has no apparent experience in medication creation, oversight or management, which has been typical for previous leaders of the biologics center. She has worked at the FDA as a key advisor to the agency head and the vaccine center since earlier this year.

“It seems she lacks to have the requisite experience” for running the drug-regulation department, said 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 CBER would “grasp legal statutes and the research of pharmaceutical innovation”, commented Dr. Janet Woodcock. “Objectively, she doesn’t have the type of experience that prior appointees who headed CBER have had.”

The drug center has an enormous workload at the FDA, the former commissioner emphasized.

“Many people just zeroes in on the novel medication approvals, but the generic drug division authorizes thousands of off-brand pharmaceuticals. There’s a biosimilars program, OTC medication office and other areas, and all of those must be managed,” she explained. “The area you neglect, that’s the thing that I always told people is going to cause problems.”

Furthermore, a major administrative aspect to the job, which manages over 5,000 personnel. “It’s a enormous management job, if you perform it correctly,” she concluded.

Agency Reaction and Controversial Policies

Regarding questions about Høeg’s credentials and whether this selection signifies increased cooperation among regulatory chiefs on immunizations, a press secretary responded that the “inquiries rely on flawed presumptions”.

“This background matches the functions of her role,” the official said, pointing to the time Høeg spent counseling the FDA commissioner on “medication safety and approval science, including computational safety modeling and shot safety tracking”.

As the temporary head, Høeg assumes responsibility for the agency head's controversial priority voucher program, a disputed expedited medication authorization process that apparently concerned her predecessors. “By what process are these drugs being picked for this fast-track system? Who takes the choices?” Dr. Howard asked. “There’s a lot of confidentiality going on at the agency right now.”

Overall, he remarked, “the Food and Drug Administration seems to be moving towards less stringent oversight of pharmaceuticals, except for immunizations.”

Public Past Work on Immunizations

Regarding immunizations, Dr. Høeg has a more documented, if concerning, track record, Howard observe. She published a analysis using non-validated public submissions to estimate the frequency of myocarditis after Covid vaccination. She counseled the state of Florida surgeon general Dr. Joseph Ladapo, who was said to have changed statistics to suggest COVID-19 vaccines are pose a greater threat than they are.

Part of her “wish list” for the incoming administration encompassed revising guidelines for new vaccines and discontinuing “non-essential” vaccines, she remarked following the vote on a online show. At the FDA, Høeg has reportedly proposed preventing teenage boys from receiving Covid vaccines.

“She’s an complete dogmatist who begins with her beliefs and reverse-engineers to retrofit the data in a highly disingenuous, untruthful manner,” Dr. Howard argued.

Consolidating Power and a “Revenge Tour”

Høeg aligned with other contrarians, {like|