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As the US undertakes unprecedented revisions to its vaccine guidelines, one figure appears somewhat surprisingly: Høeg, an American of Danish descent sports medicine doctor and public health researcher who initially gained attention by expressing skepticism about coronavirus vaccines throughout the pandemic and has focused upon alleged fatalities after Covid immunization in her recent position at the US Food and Drug Administration (FDA).

Scheduled Shifts to Pediatric Vaccine Schedule

Agency leaders had intended to reveal sweeping revisions to the childhood vaccination calendar earlier this month, synchronizing the US with Denmark’s immunization schedule, it is understood – a substantial departure that would put the US out of alignment with many the global community with no evidence for benefit. The announcement has been delayed until the coming year.

Rather than the director of the vaccine center, Høeg is scheduled to speak at the meeting. She was just designated temporary leader of the FDA’s CDER, the fifth person to run the center this year.

Consolidating Power at the Regulatory Body

The acting appointment might represent a closer partnership between the pharmaceutical and vaccine branches as Dr. Høeg and Prasad solidify control at the FDA – and it points to a renewed priority upon rolling back already-approved vaccines at the FDA.

Høeg has frequently advocated for halting some childhood immunization guidelines in the US to become more like the Danish model, a nation with comprehensive healthcare and a population roughly the population of Wisconsin’s.

In her initial comments, she has kept her attention on vaccines – traditionally the domain of Dr. Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than drug regulation.

Concerns Over Qualifications

Dr. Høeg has little discernible track record in pharmaceutical research, approval processes or administrative roles, which has been customary for previous leaders of the CBER. She has worked at the FDA as a senior adviser to the FDA chief and the vaccine center since spring.

“It seems she lacks to have the necessary background” for running the pharmaceutical oversight division, said Dr. Jonathan Howard. “She lacks experience running a scientific study. She has no expertise in leading a large organization. She is not an expert in pharmaceutical oversight.”

Previous heads of the center would “be deeply familiar with legal statutes and the research of pharmaceutical innovation”, noted a former acting FDA commissioner. “Objectively, she lacks the type of experience that former directors who ran the center have had.”

This division has an immense workload at the agency, she pointed out.

“Many people just focuses on the new drug program, but the generic drug division authorizes numerous generic drugs. There’s a biosimilars division, OTC medication office and other areas, and every single one must be supervised,” Woodcock noted. “The area you neglect, that is the part that I always told people is going to cause problems.”

Additionally, a significant management element to the job, which oversees over 5,000 employees. “It’s a massive leadership role, if you do it right,” Woodcock said.

Response and Contentious Initiatives

When asked about concerns about Dr. Høeg's credentials and whether this assignment signifies more teamwork among regulatory chiefs on immunizations, a representative said that the “concerns rely on inaccurate assumptions”.

“Her resume aligns with the functions of her job,” the official stated, citing the period Dr. Høeg spent counseling the FDA commissioner on “medication safety and regulatory science, including computerized risk analysis and vaccine surveillance”.

As the temporary head, Dr. Høeg inherits the commissioner’s new priority voucher program, a controversial one-day therapy clearance system that allegedly troubled her former heads. “How are these medications being chosen for this expedited pathway? Who takes the choices?” Dr. Howard asked. “There’s a lot of confidentiality happening at the regulatory body right now.”

Broadly speaking, he remarked, “the FDA looks to be trending towards laxer regulations of all drugs, with the exception of vaccines.”

Documented Track Record on Immunizations

Concerning vaccines, Høeg has a clearer, if problematic, history, critics have noted. She authored a research paper using unconfirmed public submissions to estimate the rate of myocarditis after COVID-19 immunization. She consulted for the state of Florida surgeon general Joseph Ladapo, who allegedly have modified findings to suggest COVID-19 vaccines are pose a greater threat than they are.

Part of her “policy goals” for the incoming government featured revising regulations for new vaccines and discontinuing “optional” immunizations, she remarked post-election on a audio program. At the FDA, Høeg has according to sources floated the idea of barring young men from getting COVID-19 vaccines.

“She’s an complete ideologue who commences with her conclusions and tailors the evidence to retrofit the evidence in a very disingenuous, fraudulent fashion,” Dr. Howard argued.

Consolidating Power and a “Push for Payback”

Høeg became part of fellow contrarians, {like|