🔗 Share this article

Given that the US proceeds with historic revisions to its vaccine recommendations, an unexpected name has emerged in a surprising turn: Høeg, an American of Danish descent physician and public health researcher who rose to prominence by casting doubt on coronavirus vaccinations during the global health crisis and has zeroed in on potential fatalities following COVID-19 vaccination in her recent tenure at the FDA.

Proposed Overhauls to Childhood Immunization Schedule

Agency leaders were set to announce radical revisions to the pediatric vaccine schedule recently, synchronizing the US with Denmark’s national calendar, according to reports – a major change that would place the US out of step with a large portion of the global community with little proof for benefit. This reveal has been pushed back until the next year.

Rather than the top vaccines chief, Høeg is scheduled to address the audience at the meeting. She was recently named acting director of the FDA’s CDER, the fifth individual to run the center this year.

Consolidating Power at the Agency

Høeg's temporary position could signify a tighter collaboration between the pharmaceutical and biologics branches as Dr. Høeg and Dr. Prasad strengthen their influence at the regulatory agency – and it suggests a renewed priority upon dismantling already-approved vaccines at the FDA.

Dr. Høeg has frequently advocated for ending some childhood shot schedules in the US to become more like the Danish model, a society with comprehensive healthcare and a citizenry roughly the size of Wisconsin’s.

In her initial statements, she has persisted in emphasizing on vaccines – typically the purview of Prasad, head of the FDA’s vaccine center – rather than medication approval.

Questions Over Background

The appointee has no apparent background in drug development, approval processes or leadership, which has been customary for past directors of the CBER. She has served at the FDA as a key advisor to the commissioner and the vaccine center since March.

“She doesn’t seem to have the requisite experience” for leading the drug-regulation department, remarked Dr. Jonathan Howard. “She has not conducted a randomized controlled trial. She lacks experience in leading a large organization. She lacks background in drug approvals.”

Former commissioners of CBER would “understand legal statutes and the underlying principles of pharmaceutical innovation”, said a former acting FDA commissioner. “Frankly, she has not acquired the type of experience that previous people who headed the center have had.”

This division has an immense workload at the agency, the former commissioner emphasized.

“The public just focuses on the new drug program, but the off-patent medication office authorizes numerous off-brand pharmaceuticals. There’s a biosimilars division, OTC medication office and more, and every single one have to be managed,” she explained. “The responsibility you overlook, that’s the thing that I always told people is going to bite you.”

There is also, a substantial management aspect to the role, which manages over 5,000 personnel. “It’s a huge administrative position, if you do it right,” she said.

Agency Reaction and Contentious Initiatives

Regarding concerns about Høeg’s fitness for the role and whether this selection signifies more teamwork among FDA leaders on immunizations, a representative responded that the “questions rely on flawed presumptions”.

“Her experience is consistent with the functions of her job,” the official said, citing the period Dr. Høeg spent guiding the agency head on “medication safety and approval science, including computational safety modeling and immunization monitoring”.

As acting director, Dr. Høeg inherits the commissioner’s recently launched expedited review system, a contentious one-day medication authorization process that apparently troubled her former heads. “By what process are these medications being chosen for this expedited pathway? Who makes the decisions?” Dr. Howard said. “There’s a lot of secrecy going on at the FDA right now.”

In general, he stated, “the FDA appears to be shifting towards less stringent rules of most medications, with the exception of vaccines.”

Established Track Record on Vaccines

With immunizations, Dr. Høeg has a more documented, if problematic, past, some experts have noted. She released a research paper using non-validated volunteer-provided data to determine the incidence of heart inflammation following Covid vaccination. She advised the Florida surgeon general Dr. Joseph Ladapo, who reportedly have modified findings to suggest COVID-19 vaccinations are more dangerous than they are.

Among her “desired changes” for the current federal leadership included changing regulations for novel immunizations and ending “optional” immunizations, she stated after the election on a podcast. At the agency, Dr. Høeg has according to sources floated the idea of barring young men from getting Covid vaccinations.

“She is an thorough dogmatist who starts off with her beliefs and tailors the evidence to fit the science in a very deceptive, dishonest fashion,” Dr. Howard stated.

Consolidating Power and a “Campaign of Retribution”

Dr. Høeg aligned with fellow contrarians, {like|