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Given that America continues making sweeping adjustments to its immunization recommendations, an unexpected name appears in a surprising turn: Høeg, a Danish American physician and epidemiologist who rose to prominence by expressing skepticism about Covid vaccines throughout the global health crisis and has concentrated on possible deaths after COVID-19 vaccination in her brief time at the Food and Drug Administration.

Proposed Changes to Pediatric Immunization Program

Health officials had intended to unveil radical revisions to the childhood vaccine schedule in December, aligning the US with Denmark’s vaccine program, according to reports – a significant shift that would place the US at odds with many the international standard with insufficient data for improved outcomes. This reveal has been postponed until the next year.

Rather than the director of the vaccine center, Dr. Høeg is set to present at the event. She was recently named acting director of the FDA’s CDER, the fifth person to lead the center this year.

A Shift at the FDA

This interim role may indicate a tighter collaboration between the drug and biologics divisions as Høeg and Prasad solidify control at the agency – and it points to a renewed priority upon dismantling already-approved immunizations at the FDA.

The new acting director has repeatedly called for discontinuing specific pediatric shot schedules in the US to become more similar to the Danish model, a society with nationalized medicine and a citizenry about the population of Wisconsin’s.

In her initial comments, she has kept her attention on immunizations – typically the purview of Prasad, chief of the FDA’s Center for Biologics Evaluation and Research (CBER) – instead of pharmaceutical oversight.

Questions Over Background

Høeg has no obvious track record in drug development, regulation or management, which has been customary for previous leaders of the biologics center. She has worked at the FDA as a key advisor to the agency head and CBER since spring.

“She doesn’t seem to have the requisite experience” for running the CDER, remarked Jonathan Howard. “She has not conducted a randomized controlled trial. She has no expertise in managing a major agency. She lacks background in industry regulation.”

Past heads of the center would “understand laws and regulations and the research of medication creation”, commented a former acting FDA commissioner. “Frankly, she has not acquired the type of experience that prior appointees who led the center have had.”

CDER has an enormous portfolio at the agency, Woodcock stated.

“The public just pays attention on the new drug program, but the generic drug division approves numerous generic drugs. There is also a biosimilars division, OTC medication office and other areas, and every single one need to be managed,” Woodcock noted. “The responsibility you neglect, that’s the thing that I always told people is going to come back to haunt you.”

Furthermore, a substantial administrative element to the job, which oversees more than 5,000 employees. “It’s a massive administrative position, if you execute it properly,” she said.

Response and Controversial Initiatives

When asked about concerns about Høeg’s fitness for the role and whether this assignment represents increased cooperation among FDA leaders on vaccines, a representative stated that the “inquiries rely on flawed assumptions”.

“This background aligns with the duties of her role,” the spokesperson explained, citing the time Dr. Høeg spent counseling the FDA commissioner on “pharmaceutical safety and approval science, including predictive safety algorithms and vaccine surveillance”.

In her interim role, Dr. Høeg assumes responsibility for the agency head's controversial fast-track approval initiative, a controversial rapid medication authorization process that apparently concerned her predecessors. “By what process are these drugs being selected for this expedited pathway? Who makes the decisions?” Dr. Howard questioned. “There is a lot of confidentiality going on at the agency right now.”

Overall, he said, “the FDA looks to be trending towards more relaxed oversight of most medications, with the exception of vaccines.”

Documented History on Immunizations

Concerning immunizations, Dr. Høeg has a more established, if concerning, history, critics observe. She published a study using unconfirmed public submissions to estimate the frequency of heart inflammation after COVID-19 vaccination. She consulted for the state of Florida surgeon general Joseph Ladapo, who was said to have altered data to suggest COVID-19 vaccinations are more dangerous than they are.

Among her “policy goals” for the current administration included changing guidelines for novel immunizations and discontinuing “unnecessary” immunizations, she said following the vote on a podcast. At the agency, Høeg has reportedly floated the idea of excluding adolescent males from getting COVID-19 vaccinations.

“She is an thorough dogmatist who begins with her preconceived notions and reverse-engineers to retrofit the data in a extremely disingenuous, dishonest manner,” Howard stated.

Taking Control and a “Revenge Tour”

Høeg joined fellow dissenters, {like|