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As the US continues making unprecedented changes to its vaccination recommendations, a particular individual has surfaced somewhat surprisingly: Høeg, a Danish American sports physician and public health researcher who initially gained attention by expressing skepticism about COVID-19 vaccinations during the pandemic and has concentrated on alleged deaths after COVID-19 immunization in her brief time at the Food and Drug Administration.

Proposed Overhauls to Childhood Immunization Schedule

Agency leaders were set to announce major revisions to the pediatric immunization program earlier this month, aligning the US with Denmark’s national calendar, it is understood – a significant shift that would place the US out of alignment with a large portion of the international standard with insufficient data for benefit. The planned update has been pushed back until the new year.

Instead of Vinay Prasad, Høeg is listed to speak at the meeting. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to run the center this calendar year.

Consolidating Power at the FDA

This interim role may indicate a closer partnership between the pharmaceutical and biologics centers as Høeg and Prasad strengthen their influence at the agency – and it points to a renewed priority upon rolling back previously authorized immunizations at the FDA.

The new acting director has often pushed for halting certain pediatric immunization guidelines in the US so as to align more like Denmark's approach, a society with comprehensive healthcare and a number of inhabitants about the size of the state of Wisconsin.

In her initial comments, she has continued to focus on immunizations – typically the purview of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of drug regulation.

Questions Over Qualifications

Høeg has no obvious track record in pharmaceutical research, regulation or leadership, which has been typical for past heads of the Center for Biologics Evaluation and Research. She has worked at the FDA as a key advisor to the commissioner and CBER since spring.

“She doesn’t seem to have the necessary background” for leading the pharmaceutical oversight division, said Dr. Jonathan Howard. “She has not conducted a scientific study. She has no expertise in managing a sizeable institution. She has no expertise in pharmaceutical oversight.”

Past heads of the center would “grasp regulatory frameworks and the science of medication creation”, said a former acting FDA commissioner. “Frankly, she has not acquired the type of experience that former directors who led the center have had.”

CDER has an vast workload at the FDA, the former commissioner stated.

“The public just pays attention on the new drug program, but the off-patent medication office approves numerous off-brand pharmaceuticals. There’s a biologic copycat branch, OTC medication office and more, and each of these must be looked after,” she said. “The responsibility you neglect, that is the part that I always told people is going to bite you.”

Additionally, a substantial administrative component to the role, which oversees over 5,000 personnel. “It is a enormous administrative position, if you execute it properly,” the former official added.

Official Statement and Disputed Policies

When asked about questions about Høeg’s credentials and whether this selection signifies more teamwork among agency officials on immunizations, a press secretary responded that the “concerns rely on inaccurate assumptions”.

“This background matches the functions of her position,” the official explained, citing the period Høeg spent guiding the agency head on “pharmaceutical safety and regulatory science, including predictive safety algorithms and immunization monitoring”.

In her interim role, Dr. Høeg takes over the agency head's controversial expedited review system, a controversial rapid therapy clearance system that apparently concerned her predecessors. “By what process are these medications being selected for this fast-track system? Who is making the calls?” Dr. Howard asked. “There’s a lot of secrecy happening at the FDA right now.”

Overall, he stated, “the FDA seems to be moving towards more relaxed regulations of pharmaceuticals, except for vaccines.”

Public Track Record on Vaccines

Regarding vaccines, Høeg has a more documented, if concerning, past, Howard have noted. She released a research paper using non-validated volunteer-provided data to determine the frequency of myocarditis following Covid vaccination. She counseled the Florida surgeon general Joseph Ladapo, who reportedly have modified findings to indicate Covid vaccinations are more dangerous than they are.

Included in her “desired changes” for the incoming government featured changing regulations for recently developed shots and discontinuing “non-essential” immunizations, she remarked after the election on a audio program. At the agency, Dr. Høeg has allegedly suggested excluding adolescent males from getting Covid vaccinations.

“She’s an all-around dogmatist who starts off with her beliefs and tailors the evidence to fit the science in a extremely misleading, untruthful way,” Dr. Howard said.

Taking Control and a “Campaign of Retribution”

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