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While the US proceeds with historic adjustments to its vaccination schedules, an unexpected name has emerged in a surprising turn: Høeg, an American of Danish descent physician and epidemiologist who first made her name by questioning Covid vaccinations in the global health crisis and has focused upon alleged deaths following COVID-19 immunization in her short time at the US Food and Drug Administration (FDA).

Planned Changes to Childhood Immunization Program

Health officials had intended to announce major revisions to the childhood vaccine schedule earlier this month, synchronizing the US with Denmark’s immunization schedule, it is understood – a significant shift that would put the US at odds with much of the international standard with no evidence for improved outcomes. The announcement has been delayed until the next year.

In place of Vinay Prasad, Dr. Høeg is listed to address the audience at the meeting. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to head the office this year.

Consolidating Power at the Regulatory Body

Høeg's temporary position could signify a strengthened alliance between the pharmaceutical and vaccine branches as Høeg and Prasad consolidate power at the agency – and it signals a greater focus upon dismantling previously authorized vaccines at the FDA.

Høeg has often pushed for ending some childhood vaccine recommendations in the US in order to be more in line with Denmark's approach, a society with universal health coverage and a population about the population of Wisconsin’s.

In her initial statements, she has persisted in emphasizing on vaccination policy – traditionally the responsibility of Prasad, chief of the FDA’s CBER – instead of pharmaceutical oversight.

Doubts Over Qualifications

Høeg has little discernible background in medication creation, regulation or leadership, which has been customary for past leaders of the biologics center. She has worked at the FDA as a top consultant to the agency head and CBER since spring.

“She doesn’t seem to have any of the qualifications” for running the CDER, stated Jonathan Howard. “She’s never run a scientific study. She has no expertise in running a major agency. She is not an expert in drug approvals.”

Past commissioners of CBER would “understand laws and regulations and the science of drug development”, commented Dr. Janet Woodcock. “Clearly, she has not acquired the sort of resume that prior appointees who ran CBER have had.”

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

“Many people just zeroes in on the new drug program, but the off-patent medication office approves a multitude of generic medications. There’s a biologic copycat branch, non-prescription drug unit and so forth, and every single one must be supervised,” she explained. “The area you neglect, that is the part that I always told people is going to cause problems.”

Furthermore, a significant leadership aspect to the position, which oversees over 5,000 employees. “It’s a huge administrative position, if you do it right,” Woodcock concluded.

Agency Reaction and Contentious Initiatives

Regarding concerns about Dr. Høeg's fitness for the role and whether this appointment represents greater collaboration among agency officials on immunizations, a representative said that the “questions stem from inaccurate premises”.

“Her resume aligns with the responsibilities of her job,” the official explained, noting the time Høeg spent guiding the agency head on “medication safety and regulatory science, including computational safety modeling and shot safety tracking”.

As acting director, Høeg assumes responsibility for the agency head's new fast-track approval initiative, a contentious expedited drug-approval program that reportedly concerned her predecessors. “By what process are these medications being picked for this voucher program? Who takes the decisions?” Dr. Howard questioned. “There’s a lot of secrecy happening at the agency right now.”

Broadly speaking, he remarked, “the FDA seems to be moving towards more relaxed regulations of all drugs, with the exception of vaccines.”

Documented Track Record on Vaccines

With vaccines, Dr. Høeg has a more documented, if troubling, history, some experts said. She authored a analysis using unverified volunteer-provided data to estimate the rate of heart inflammation after COVID-19 vaccination. She advised the Florida surgeon general Joseph Ladapo, who was said to have changed statistics to suggest Covid vaccinations are more dangerous than they are.

Included in her “wish list” for the new federal leadership included altering regulations for new vaccines and ending “unnecessary” immunizations, she stated after the election on a online show. At the FDA, Dr. Høeg has according to sources suggested preventing young men from getting COVID-19 vaccinations.

“She’s an all-around true believer who starts off with her conclusions and reverse-engineers to accommodate the science in a very deceptive, untruthful fashion,” Dr. Howard said.

Consolidating Power and a “Campaign of Retribution”

Høeg aligned with fellow skeptics, {like|