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While the US undertakes historic changes to its immunization schedules, a particular individual has surfaced somewhat surprisingly: Høeg, a US-based sports medicine doctor and epidemiologist who initially gained attention by expressing skepticism about coronavirus shots throughout the pandemic and has focused upon potential fatalities after Covid vaccination in her short position at the Food and Drug Administration.

Planned Shifts to Pediatric Vaccine Schedule

Agency leaders were set to unveil sweeping revisions to the pediatric immunization program earlier this month, aligning the US with the Danish immunization schedule, it is understood – a significant shift that would put the US at odds with many the world with no evidence for public health gain. This reveal has been postponed until the new year.

Instead of Vinay Prasad, Dr. Høeg is set to speak at the event. She was recently named acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to head the center this year.

A Shift at the Agency

Høeg's temporary position could signify a strengthened alliance between the drug and biologics branches as Høeg and Dr. Prasad solidify control at the agency – and it points to a greater focus upon dismantling already-approved vaccines at the FDA.

Dr. Høeg has frequently advocated for discontinuing certain pediatric shot schedules in the US to become more in line with the Danish model, a country with nationalized medicine and a population roughly the population of Wisconsin’s.

In her initial public appearances, she has persisted in emphasizing on immunizations – usually the domain of Dr. Prasad, chief of the FDA’s vaccine center – rather than pharmaceutical oversight.

Doubts Over Qualifications

Høeg has no apparent track record in pharmaceutical research, regulation or management, which has been typical for previous leaders of the CBER. She has been employed at the FDA as a senior adviser to the commissioner and CBER since March.

“It seems she lacks to have the requisite experience” for leading the CDER, said Dr. Jonathan Howard. “She lacks experience running a scientific study. She has no expertise in managing a large organization. She has no expertise in pharmaceutical oversight.”

Previous directors of the center would “be deeply familiar with laws and regulations and the science of drug development”, said Dr. Janet Woodcock. “Frankly, she lacks the sort of resume that prior appointees who led CBER have had.”

CDER has an vast range of responsibilities at the FDA, Woodcock stated.

“The public just focuses on the new drug program, but the generic drug division clears thousands of generic drugs. There is also a biosimilars division, OTC medication office and so forth, and all of those have to be managed,” Dr. Woodcock noted. “The area you don’t keep your eye on, that is precisely what that I always told people is going to cause problems.”

There is also, a significant leadership aspect to the role, which manages more than 5,000 personnel. “It’s a huge leadership role, if you perform it correctly,” Woodcock concluded.

Official Statement and Contentious Policies

In response to questions about Dr. Høeg's qualifications and whether this selection signifies greater collaboration among agency officials on immunizations, a press secretary stated that the “inquiries rely on flawed premises”.

“This background aligns with the duties of her job,” the official explained, pointing to the period Dr. Høeg spent counseling the FDA commissioner on “drug safety and oversight research, including computational safety modeling and vaccine surveillance”.

In her interim role, Dr. Høeg inherits the commissioner’s new fast-track approval initiative, a controversial expedited medication authorization process that apparently worried her former heads. “How are these drugs being chosen for this expedited pathway? Who takes the choices?” Howard said. “There is a lot of confidentiality going on at the agency right now.”

Broadly speaking, he remarked, “the Food and Drug Administration seems to be moving towards less stringent rules of all drugs, except for vaccines.”

Documented Track Record on Vaccines

Regarding immunizations, Dr. Høeg has a more documented, if troubling, track record, critics have noted. She published a research paper using unverified public submissions to estimate the frequency of myocarditis following COVID-19 vaccination. She advised the state of Florida surgeon general Dr. Joseph Ladapo, who was said to have modified findings to indicate Covid vaccinations are more dangerous than they are.

Part of her “desired changes” for the current administration featured changing guidelines for new vaccines and discontinuing “unnecessary” immunizations, she remarked after the election on a audio program. At the agency, Dr. Høeg has according to sources suggested preventing adolescent males from obtaining Covid vaccines.

“She’s an complete dogmatist who commences with her beliefs and tailors the evidence to accommodate the data in a extremely deceptive, untruthful fashion,” Howard said.

Gaining Influence and a “Push for Payback”

Dr. Høeg became part of fellow dissenters, {like|