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Given that the US proceeds with unprecedented revisions to its vaccine guidelines, one figure appears somewhat surprisingly: Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by questioning coronavirus shots during the global health crisis and has zeroed in on possible deaths following COVID-19 immunization in her short tenure at the FDA.

Proposed Changes to Childhood Vaccine Schedule

Agency leaders had intended to announce sweeping changes to the childhood vaccination calendar earlier this month, bringing the US with Denmark’s national calendar, it is understood – a major change that would place the US out of alignment with a large portion of the world with no evidence for public health gain. The planned update has been delayed until the next year.

In place 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 individual to lead the office this calendar year.

A New Direction at the Agency

The acting appointment could signify a tighter collaboration between the pharmaceutical and vaccine centers as Dr. Høeg and Prasad consolidate power at the regulatory agency – and it points to a renewed priority upon reevaluating already-approved vaccines at the FDA.

Høeg has often pushed for halting specific pediatric shot schedules in the US in order to be more in line with the Danish model, a society with nationalized medicine and a citizenry about the size of the state of Wisconsin.

So far statements, she has continued to focus on vaccination policy – traditionally the responsibility of Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than medication approval.

Questions Over Expertise

Dr. Høeg has no obvious track record in pharmaceutical research, approval processes or management, which has been customary for past heads of the biologics center. She has worked at the FDA as a top consultant to the agency head and CBER since March.

“It seems she lacks to have the necessary background” for leading the CDER, remarked Jonathan Howard. “She has not conducted a clinical trial. She has no expertise in leading a major agency. She has no expertise in industry regulation.”

Past heads of CBER would “grasp laws and regulations and the underlying principles of drug development”, said Janet Woodcock. “Objectively, she doesn’t have the kind of background that prior appointees who ran the center have had.”

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

“The public just focuses on the new drug program, but the generic drug division approves numerous off-brand pharmaceuticals. There is also a biosimilars division, over-the-counter program and so forth, and every single one must be supervised,” Dr. Woodcock noted. “The responsibility you neglect, that’s the thing that I always told people is going to come back to haunt you.”

Furthermore, a major management element to the position, which manages in excess of 5,000 personnel. “It’s a massive management job, if you do it right,” she added.

Official Statement and Controversial Policies

Regarding inquiries about Høeg’s credentials and whether this appointment signifies more teamwork among regulatory chiefs on immunizations, a representative stated that the “concerns are based on flawed presumptions”.

“Her experience is consistent with the duties of her position,” the representative stated, citing the time Dr. Høeg spent advising the agency head on “drug safety and oversight research, including computerized risk analysis and vaccine surveillance”.

As the temporary head, Høeg assumes responsibility for the commissioner’s new priority voucher program, a contentious expedited therapy clearance system that reportedly worried her former heads. “How are these therapies being chosen for this voucher program? Who takes the calls?” Dr. Howard asked. “There is a lot of lack of transparency going on at the regulatory body right now.”

Overall, he remarked, “the agency looks to be trending towards more relaxed regulations of pharmaceuticals, aside from shots.”

Public Track Record on Immunizations

Concerning vaccines, Dr. Høeg has a more established, if troubling, history, Howard have noted. She released a study using unverified crowd-sourced reports to assess the frequency of myocarditis following COVID-19 vaccination. She advised the Florida top health official Dr. Joseph Ladapo, who reportedly have modified findings to suggest Covid vaccines are riskier than they are.

Part of her “wish list” for the current administration featured revising guidelines for new vaccines and ending “optional” immunizations, she said post-election on a audio program. At the FDA, Dr. Høeg has allegedly suggested excluding teenage boys from receiving Covid vaccines.

“She is an thorough dogmatist who commences with her beliefs and works backwards to fit the evidence in a very deceptive, dishonest manner,” Howard stated.

Taking Control and a “Campaign of Retribution”

Dr. Høeg became part of other skeptics, {like|