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Given that the United States undertakes unprecedented changes to its vaccination recommendations, a particular individual has emerged somewhat surprisingly: Høeg, an American of Danish descent sports medicine doctor and public health researcher who initially gained attention by questioning COVID-19 shots during the pandemic and has concentrated on alleged fatalities following COVID-19 immunization in her recent time at the Food and Drug Administration.

Planned Changes to Pediatric Vaccine Schedule

Public health authorities planned to unveil sweeping changes to the childhood vaccination calendar in December, bringing the US with the Danish vaccine program, sources say – a major change that would put the US out of step with a large portion of the global community with insufficient data for public health gain. This reveal has been delayed until the new year.

Rather than Vinay Prasad, Dr. Høeg is listed to present at the event. She was newly appointed interim head of the FDA’s CDER, the fifth person to lead the center this year.

A New Direction at the Agency

This interim role could signify a closer partnership between the drug and vaccine centers as Høeg and Prasad consolidate power at the FDA – and it signals a renewed priority upon reevaluating long-standing vaccines at the FDA.

Høeg has repeatedly called for ending specific pediatric vaccine recommendations in the US so as to align more in line with Denmark, a nation with comprehensive healthcare and a number of inhabitants approximately the population of Wisconsin’s.

In her initial public appearances, she has persisted in emphasizing on vaccination policy – typically the purview of Prasad, director of the FDA’s CBER – as opposed to drug regulation.

Doubts Over Expertise

Dr. Høeg has no apparent experience in pharmaceutical research, oversight or leadership, which has been standard for previous directors of the Center for Biologics Evaluation and Research. She has worked at the FDA as a key advisor to the FDA chief and CBER since spring.

“She appears not to have any of the qualifications” for running the drug-regulation department, remarked a neurologist and psychiatrist. “She lacks experience running a randomized controlled trial. She lacks experience in leading a sizeable institution. She lacks background in industry regulation.”

Past directors of CBER would “grasp legal statutes and the research of medication creation”, said a former acting FDA commissioner. “Objectively, she has not acquired the kind of background that former directors who led the center have had.”

The drug center has an vast workload at the agency, she pointed out.

“Everybody just focuses on the novel medication approvals, but the generic program clears numerous generic drugs. There is also a biosimilars program, over-the-counter program and other areas, and all of those must be looked after,” she said. “The responsibility you neglect, that is precisely what that I always told people is going to cause problems.”

There is also, a major leadership component to the position, which manages in excess of 5,000 personnel. “It’s a enormous administrative position, if you execute it properly,” she added.

Response and Disputed Policies

When asked about questions about Høeg’s credentials and whether this selection indicates greater collaboration among regulatory chiefs on vaccines, a spokesperson said that the “inquiries stem from flawed presumptions”.

“Her resume aligns with the duties of her position,” the representative stated, citing the period Høeg spent guiding the FDA commissioner on “pharmaceutical safety and oversight research, including predictive safety algorithms and vaccine surveillance”.

As acting director, Dr. Høeg assumes responsibility for the agency head's new priority voucher program, a contentious rapid drug-approval program that apparently concerned her former heads. “By what process are these medications being picked for this expedited pathway? Who is making the decisions?” Dr. Howard questioned. “There’s a lot of lack of transparency occurring at the FDA right now.”

Overall, he stated, “the FDA looks to be trending towards less stringent regulations of all drugs, aside from immunizations.”

Public History on Immunizations

Concerning vaccines, Dr. Høeg has a more established, if concerning, past, Howard have noted. She authored a analysis using non-validated volunteer-provided data to determine the incidence of heart inflammation after COVID-19 vaccination. She counseled the state of Florida chief medical officer Dr. Joseph Ladapo, who allegedly have modified findings to suggest Covid vaccinations are more dangerous than they are.

Part of her “policy goals” for the current government included changing rules for novel immunizations and discontinuing “optional” vaccines, she remarked following the vote on a online show. At the FDA, Høeg has according to sources proposed excluding teenage boys from receiving Covid vaccinations.

“She is an complete true believer who begins with her preconceived notions and reverse-engineers to accommodate the evidence in a extremely disingenuous, fraudulent way,” Dr. Howard argued.

Consolidating Power and a “Revenge Tour”

Dr. Høeg joined fellow dissenters, {like|