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While the United States continues making unprecedented changes to its vaccine schedules, one figure appears somewhat surprisingly: Høeg, a US-based sports physician and public health researcher who rose to prominence by casting doubt on COVID-19 vaccinations throughout the pandemic and has zeroed in on alleged fatalities after COVID-19 immunization in her recent tenure at the Food and Drug Administration.

Proposed Overhauls to Pediatric Vaccine Program

Public health authorities planned to announce sweeping changes to the childhood vaccine schedule recently, synchronizing the US with the Danish immunization schedule, sources say – a major change that would place the US at odds with much of the global community with no evidence for improved outcomes. This reveal has been delayed until the new year.

Rather than the director of the vaccine center, Høeg is scheduled to address the audience at the gathering. She was newly appointed interim head of the FDA’s drug evaluation center, the fifth individual to head the office this year.

A New Direction at the Agency

Høeg's temporary position might represent a closer partnership between the drug and vaccine centers as Dr. Høeg and Dr. Prasad solidify control at the FDA – and it suggests a renewed priority upon rolling back already-approved vaccines at the FDA.

The new acting director has often pushed for discontinuing specific pediatric vaccine recommendations in the US in order to be more in line with Denmark's approach, a country with nationalized medicine and a population about the population of Wisconsin’s.

In her initial statements, she has persisted in emphasizing on vaccination policy – usually the purview of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of drug regulation.

Questions Over Background

Høeg has little discernible background in pharmaceutical research, regulation or leadership, which has been standard for previous directors of the CBER. She has served at the FDA as a top consultant to the agency head and CBER since spring.

“It seems she lacks to have any of the qualifications” for running the pharmaceutical oversight division, stated a neurologist and psychiatrist. “She has not conducted a clinical trial. She lacks experience in leading a large organization. She lacks background in pharmaceutical oversight.”

Past commissioners of the center would “understand regulatory frameworks and the research of pharmaceutical innovation”, commented Janet Woodcock. “Frankly, she lacks the type of experience that previous people who headed CBER have had.”

CDER has an enormous workload at the FDA, the former commissioner stated.

“Everybody just zeroes in on the innovative therapies, but the generic program clears thousands of off-brand pharmaceuticals. There’s a biosimilars program, over-the-counter program and more, and all of those must be managed,” Dr. Woodcock explained. “The responsibility you don’t keep your eye on, that’s the thing that I always told people is going to bite you.”

Additionally, a major administrative component to the job, which oversees in excess of 5,000 employees. “It is a massive management job, if you do it right,” she said.

Agency Reaction and Contentious Initiatives

Regarding concerns about Høeg’s credentials and whether this assignment signifies greater collaboration among agency officials on vaccines, a representative said that the “inquiries stem from inaccurate presumptions”.

“Her experience is consistent with the duties of her job,” the official explained, pointing to the period Dr. Høeg spent guiding the FDA commissioner on “medication safety and regulatory science, including computerized risk analysis and immunization monitoring”.

As acting director, Dr. Høeg takes over the agency head's new priority voucher program, a contentious expedited medication authorization process that apparently worried her former heads. “How are these drugs being selected for this expedited pathway? Who takes the decisions?” Howard said. “There is a lot of confidentiality going on at the agency right now.”

Overall, he remarked, “the FDA seems to be moving towards laxer regulations of all drugs, except for immunizations.”

Established Past Work on Vaccines

With immunizations, Dr. Høeg has a more established, if problematic, past, critics observe. She published a study using unconfirmed volunteer-provided data to estimate the incidence of heart inflammation following COVID-19 vaccination. She counseled the state of Florida chief medical officer Dr. Joseph Ladapo, who allegedly have modified findings to indicate Covid vaccinations are more dangerous than they are.

Part of her “desired changes” for the incoming federal leadership included altering rules for novel immunizations and halting “unnecessary” vaccines, she remarked post-election on a audio program. At the agency, Dr. Høeg has reportedly suggested excluding teenage boys from receiving COVID-19 vaccinations.

“She’s an complete ideologue who begins with her conclusions and tailors the evidence to accommodate the data in a extremely disingenuous, untruthful fashion,” Howard said.

Taking Control and a “Campaign of Retribution”

Høeg became part of fellow dissenters, {like|