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Given that the United States proceeds with unprecedented revisions to its immunization recommendations, one figure has emerged unexpectedly: Høeg, a US-based sports physician and epidemiologist who initially gained attention by questioning Covid shots in the global health crisis and has focused upon potential fatalities following Covid immunization in her recent tenure at the Food and Drug Administration.

Planned Changes to Pediatric Vaccine Schedule

Public health authorities had intended to unveil radical changes to the pediatric immunization program earlier this month, aligning the US with the Danish national calendar, sources say – a major change that would place the US out of step with a large portion of the international standard with insufficient data for public health gain. The planned update has been pushed back until the new year.

Rather than the top vaccines chief, Høeg is listed to address the audience at the gathering. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to lead the division this calendar year.

A New Direction at the Agency

Høeg's temporary position could signify a strengthened alliance between the drug and vaccine centers as Dr. Høeg and Dr. Prasad consolidate power at the regulatory agency – and it points to a renewed priority upon dismantling already-approved immunizations at the FDA.

Dr. Høeg has often pushed for discontinuing specific pediatric shot schedules in the US so as to align more like the Danish model, a society with nationalized medicine and a population roughly the population of Wisconsin’s.

So far comments, she has kept her attention on immunizations – typically the domain of Dr. Prasad, chief of the FDA’s CBER – as opposed to pharmaceutical oversight.

Questions Over Qualifications

The appointee has little discernible background in pharmaceutical research, approval processes or leadership, which has been customary for former leaders of the biologics center. She has worked at the FDA as a key advisor to the FDA chief and CBER since March.

“She doesn’t seem to have the requisite experience” for overseeing the drug-regulation department, remarked Dr. Jonathan Howard. “She lacks experience running a clinical trial. She is not versed in leading a major agency. She lacks background in pharmaceutical oversight.”

Past commissioners of CBER would “be deeply familiar with legal statutes and the science of drug development”, noted Janet Woodcock. “Objectively, she has not acquired the type of experience that previous people who led the center have had.”

The drug center has an vast range of responsibilities at the agency, the former commissioner emphasized.

“The public just pays attention on the new drug program, but the generic program authorizes a multitude of generic medications. There’s a biosimilars program, over-the-counter program and so forth, and every single one must be looked after,” Woodcock noted. “The thing you overlook, that’s the thing that I always told people is going to cause problems.”

There is also, a major leadership element to the position, which oversees in excess of 5,000 staff members. “It is a massive management job, if you execute it properly,” the former official added.

Agency Reaction and Contentious Initiatives

When asked about concerns about Høeg’s credentials and whether this assignment indicates increased cooperation among regulatory chiefs on immunizations, a representative responded that the “inquiries are based on flawed premises”.

“This background aligns with the functions of her job,” the representative stated, citing the period Dr. Høeg spent advising the FDA commissioner on “medication safety and oversight research, including computerized risk analysis and vaccine surveillance”.

In her interim role, Høeg assumes responsibility for the agency head's controversial priority voucher program, a disputed expedited drug-approval program that reportedly troubled her former heads. “How are these medications being selected for this expedited pathway? Who takes the decisions?” Howard asked. “There is a lot of confidentiality going on at the FDA right now.”

In general, he remarked, “the agency seems to be moving towards less stringent rules of pharmaceuticals, except for shots.”

Public Past Work on Vaccines

Regarding vaccines, Dr. Høeg has a clearer, if problematic, history, some experts observe. She released a study using unconfirmed crowd-sourced reports to assess the incidence of heart inflammation after COVID-19 vaccination. She counseled the Florida chief medical officer Joseph Ladapo, who was said to have modified findings to imply Covid vaccinations are more dangerous than they are.

Included in her “desired changes” for the incoming administration featured changing guidelines for novel immunizations and discontinuing “optional” vaccines, she said following the vote on a podcast. At the FDA, Høeg has reportedly suggested barring teenage boys from receiving COVID-19 vaccines.

“She’s an complete dogmatist who begins with her preconceived notions and works backwards to fit the evidence in a very deceptive, untruthful way,” Howard stated.

Taking Control and a “Revenge Tour”

Høeg became part of fellow contrarians, {like|