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While the United States proceeds with sweeping revisions to its immunization guidelines, a particular individual appears in a surprising turn: Høeg, an American of Danish descent physician and public health researcher who initially gained attention by questioning Covid shots in the pandemic and has zeroed in on possible deaths following COVID-19 immunization in her recent time at the Food and Drug Administration.

Proposed Shifts to Pediatric Vaccine Schedule

Agency leaders were set to reveal major revisions to the pediatric vaccine schedule in December, bringing the US with Denmark’s vaccine program, according to reports – a significant shift that would place the US out of alignment with much of the international standard with insufficient data for benefit. The announcement has been delayed until the coming year.

Rather than Vinay Prasad, Høeg is set to speak at the gathering. She was recently named acting director of the FDA’s CDER, the fifth appointee to lead the office this calendar year.

A Shift at the FDA

This interim role may indicate a tighter collaboration between the pharmaceutical and vaccine divisions as Høeg and Prasad solidify control at the agency – and it signals a greater focus upon rolling back previously authorized immunizations at the FDA.

The new acting director has repeatedly called for halting some childhood vaccine recommendations in the US to become more in line with the Danish model, a country with universal health coverage and a number of inhabitants roughly the population of the state of Wisconsin.

To date statements, she has kept her attention on immunizations – usually the purview of Dr. Prasad, director of the FDA’s CBER – as opposed to drug regulation.

Concerns Over Qualifications

The appointee has no apparent background in pharmaceutical research, regulation or leadership, which has been customary for past heads of the CBER. She has served at the FDA as a key advisor to the agency head and CBER since spring.

“She appears not to have the necessary background” for leading the pharmaceutical oversight division, said a neurologist and psychiatrist. “She’s never run a clinical trial. She is not versed in running a sizeable institution. She lacks background in drug approvals.”

Previous commissioners of CBER would “be deeply familiar with legal statutes and the underlying principles of pharmaceutical innovation”, commented Janet Woodcock. “Frankly, she has not acquired the kind of background that previous people who ran the center have had.”

The drug center has an vast workload at the FDA, she stated.

“Everybody just pays attention on the new drug program, but the generic program approves numerous generic medications. There’s a biosimilars program, over-the-counter program and other areas, and each of these must be supervised,” Dr. Woodcock noted. “The area you don’t keep your eye on, that is precisely what that I always told people is going to bite you.”

Additionally, a significant leadership aspect to the job, which oversees in excess of 5,000 personnel. “It is a enormous leadership role, if you do it right,” she added.

Response and Controversial Programs

Regarding questions about Høeg’s fitness for the role and whether this assignment indicates greater collaboration among agency officials on immunizations, a representative responded that the “questions are based on incorrect presumptions”.

“This background is consistent with the responsibilities of her position,” the spokesperson stated, pointing to the months Dr. Høeg spent guiding the agency head on “pharmaceutical safety and oversight research, including computational safety modeling and shot safety tracking”.

As the temporary head, Dr. Høeg takes over the agency head's recently launched priority voucher program, a controversial rapid drug-approval program that apparently concerned her predecessors. “By what process are these medications being chosen for this fast-track system? Who makes the decisions?” Dr. Howard questioned. “There’s a lot of lack of transparency happening at the FDA right now.”

In general, he stated, “the FDA appears to be shifting towards more relaxed oversight of most medications, with the exception of shots.”

Documented Track Record on Vaccines

Regarding immunizations, Dr. Høeg has a more established, if concerning, track record, Howard have noted. She released a research paper using unconfirmed public submissions to assess the incidence of myocarditis after COVID-19 vaccination. She consulted for the Florida surgeon general Dr. Joseph Ladapo, who allegedly have modified findings to indicate Covid vaccinations are riskier than they are.

Included in her “policy goals” for the new government included altering rules for recently developed shots and halting “unnecessary” vaccines, she said after the election on a podcast. At the FDA, Høeg has according to sources floated the idea of barring teenage boys from obtaining Covid vaccines.

“She is an thorough ideologue who commences with her beliefs and reverse-engineers to retrofit the data in a extremely deceptive, dishonest way,” Howard argued.

Gaining Influence and a “Push for Payback”

Høeg joined fellow skeptics, {like|