🔗 Share this article

Given that the US undertakes unprecedented adjustments to its vaccine guidelines, an unexpected name has emerged in a surprising turn: Høeg, a Danish American sports physician and epidemiologist who first made her name by casting doubt on COVID-19 shots during the global health crisis and has focused upon potential deaths following Covid vaccination in her short tenure at the Food and Drug Administration.

Scheduled Changes to Pediatric Vaccine Schedule

Agency leaders had intended to reveal major changes to the pediatric vaccine schedule earlier this month, aligning the US with Denmark’s vaccine program, it is understood – a significant shift that would put the US out of alignment with much of the world with no evidence for benefit. The planned update has been delayed until the new year.

Instead of Vinay Prasad, Dr. Høeg is listed to speak at the event. She was newly appointed interim head of the FDA’s drug evaluation center, the fifth individual to head the center this year.

Consolidating Power at the FDA

This interim role might represent a tighter collaboration between the drug and biologics divisions as Dr. Høeg and Prasad consolidate power at the regulatory agency – and it suggests a renewed priority upon dismantling already-approved vaccines at the FDA.

Dr. Høeg has repeatedly called for discontinuing certain childhood shot schedules in the US to become more like Denmark's approach, a nation with nationalized medicine and a number of inhabitants about the population of Wisconsin’s.

So far public appearances, she has kept her attention on vaccines – usually the purview of Prasad, head of the FDA’s vaccine center – instead of medication approval.

Questions Over Background

The appointee has little discernible track record in medication creation, approval processes or administrative roles, which has been customary for past heads of the Center for Biologics Evaluation and Research. She has worked at the FDA as a senior adviser to the commissioner and the vaccine center since spring.

“She doesn’t seem to have any of the qualifications” for leading the drug-regulation department, said Jonathan Howard. “She has not conducted a randomized controlled trial. She lacks experience in running a sizeable institution. She is not an expert in drug approvals.”

Former heads of CBER would “grasp regulatory frameworks and the science of drug development”, noted Dr. Janet Woodcock. “Clearly, she doesn’t have the sort of resume that former directors who ran CBER have had.”

This division has an enormous workload at the agency, the former commissioner stated.

“Many people just pays attention on the novel medication approvals, but the off-patent medication office clears a multitude of generic drugs. There’s a biologic copycat branch, OTC medication office and other areas, and each of these need to be supervised,” Woodcock said. “The area you don’t keep your eye on, that’s the thing that I always told people is going to bite you.”

There is also, a major management component to the role, which manages more than 5,000 employees. “It is a huge management job, if you execute it properly,” Woodcock concluded.

Agency Reaction and Contentious Policies

In response to questions about Dr. Høeg's credentials and whether this assignment signifies greater collaboration among agency officials on immunizations, a spokesperson said that the “inquiries stem from flawed assumptions”.

“Her resume aligns with the responsibilities of her job,” the spokesperson said, pointing to the months Høeg spent counseling the FDA commissioner on “drug safety and regulatory science, including computerized risk analysis and vaccine surveillance”.

In her interim role, Høeg inherits the agency head's new priority voucher program, a contentious expedited drug-approval program that apparently troubled her preceding directors. “How are these medications being chosen for this expedited pathway? Who is making the choices?” Howard questioned. “There is a lot of confidentiality happening at the regulatory body right now.”

Broadly speaking, he said, “the FDA appears to be shifting towards laxer rules of all drugs, except for vaccines.”

Public Track Record on Immunizations

Regarding immunizations, Høeg has a clearer, if problematic, history, critics have noted. She released a analysis using non-validated public submissions to determine the frequency of heart inflammation following COVID-19 vaccination. She advised the Florida chief medical officer Dr. Joseph Ladapo, who reportedly have modified findings to suggest Covid vaccines are more dangerous than they are.

Part of her “desired changes” for the new federal leadership featured revising regulations for new vaccines and halting “non-essential” vaccines, she remarked after the election on a podcast. At the FDA, Høeg has according to sources proposed barring teenage boys from getting COVID-19 vaccinations.

“She is an all-around true believer who begins with her beliefs and tailors the evidence to accommodate the evidence in a extremely deceptive, untruthful way,” Dr. Howard stated.

Gaining Influence and a “Push for Payback”

Høeg became part of other dissenters, {like|