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Given that the United States continues making unprecedented revisions to its vaccination guidelines, an unexpected name has surfaced in a surprising turn: Høeg, a Danish American sports medicine doctor and public health researcher who first made her name by questioning coronavirus shots during the pandemic and has zeroed in on alleged fatalities after Covid vaccination in her short tenure at the Food and Drug Administration.

Scheduled Changes to Childhood Vaccine Schedule

Public health authorities planned to reveal major revisions to the childhood vaccination calendar in December, bringing the US with the Danish immunization schedule, according to reports – a significant shift that would place the US at odds with much of the world with little proof for benefit. The announcement has been delayed until the coming year.

In place of the director of the vaccine center, Dr. Høeg is set to address the audience at the event. She was recently named acting director of the FDA’s CDER, the fifth individual to head the center this year.

A New Direction at the Agency

This interim role may indicate a strengthened alliance between the drug and biologics centers as Dr. Høeg and Dr. Prasad consolidate power at the FDA – and it suggests a renewed priority upon reevaluating long-standing vaccines at the FDA.

The new acting director has often pushed for halting specific childhood vaccine recommendations in the US to become more similar to Denmark, a society with nationalized medicine and a population approximately the population of Wisconsin’s.

In her initial public appearances, she has kept her attention on immunizations – typically the domain of Prasad, head of the FDA’s vaccine center – as opposed to medication approval.

Doubts Over Expertise

Dr. Høeg has no obvious experience in medication creation, oversight or management, which has been standard for past heads of the Center for Biologics Evaluation and Research. She has served at the FDA as a top consultant to the agency head and CBER since earlier this year.

“It seems she lacks to have the necessary background” for leading the CDER, remarked a neurologist and psychiatrist. “She has not conducted a randomized controlled trial. She is not versed in managing a sizeable institution. She lacks background in pharmaceutical oversight.”

Past directors of CBER would “understand legal statutes and the science of drug development”, commented Dr. Janet Woodcock. “Clearly, she lacks the kind of background that former directors who headed the center have had.”

The drug center has an immense workload at the FDA, Woodcock emphasized.

“Many people just pays attention on the new drug program, but the generic drug division authorizes numerous generic medications. There is also a biosimilars program, non-prescription drug unit and other areas, and each of these need to be supervised,” Woodcock noted. “The responsibility you neglect, that’s the thing that I always told people is going to come back to haunt you.”

There is also, a significant management element to the job, which manages over 5,000 staff members. “It is a huge administrative position, if you perform it correctly,” Woodcock said.

Response and Contentious Initiatives

Regarding concerns about Dr. Høeg's qualifications and whether this selection indicates increased cooperation among agency officials on vaccines, a press secretary stated that the “concerns stem from inaccurate assumptions”.

“Her experience aligns with the functions of her position,” the representative said, noting the time Dr. Høeg spent guiding the FDA commissioner on “pharmaceutical safety and approval science, including computerized risk analysis and immunization monitoring”.

In her interim role, Dr. Høeg takes over the agency head's controversial expedited review system, a controversial expedited drug-approval program that apparently concerned her former heads. “By what process are these therapies being selected for this expedited pathway? Who is making the decisions?” Dr. Howard asked. “There is a lot of lack of transparency occurring at the FDA right now.”

Broadly speaking, he stated, “the FDA seems to be moving towards laxer oversight of pharmaceuticals, with the exception of shots.”

Documented Past Work on Immunizations

Regarding immunizations, Høeg has a more documented, if problematic, track record, some experts observe. She published a analysis using unverified volunteer-provided data to assess the rate of myocarditis following COVID-19 vaccination. She consulted for the state of Florida top health official Joseph Ladapo, who reportedly have altered data to suggest COVID-19 vaccinations are pose a greater threat than they are.

Included in her “wish list” for the new administration featured changing guidelines for novel immunizations and discontinuing “non-essential” vaccines, she said after the election on a audio program. At the FDA, Høeg has allegedly floated the idea of barring young men from getting COVID-19 vaccines.

“She’s an all-around true believer who starts off with her preconceived notions and tailors the evidence to fit the evidence in a extremely misleading, dishonest fashion,” Dr. Howard stated.

Gaining Influence and a “Push for Payback”

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