🔗 Share this article

While the United States undertakes sweeping revisions to its vaccination schedules, one figure has emerged unexpectedly: Høeg, a Danish American physician and epidemiologist who initially gained attention by expressing skepticism about Covid shots in the pandemic and has zeroed in on potential deaths following COVID-19 vaccination in her recent position at the Food and Drug Administration.

Planned Changes to Childhood Vaccine Schedule

Public health authorities had intended to announce major revisions to the childhood vaccine schedule in December, synchronizing the US with the Danish vaccine program, sources say – a major change that would put the US at odds with a large portion of the world with no evidence for public health gain. The announcement has been pushed back until the new year.

Rather than the director of the vaccine center, Høeg is listed to speak at the gathering. She was recently named interim head of the FDA’s drug evaluation center, the fifth person to lead the center this year.

A Shift at the Regulatory Body

Høeg's temporary position could signify a tighter collaboration between the drug and vaccine centers as Dr. Høeg and Prasad solidify control at the regulatory agency – and it suggests a greater focus upon dismantling long-standing vaccines at the FDA.

The new acting director has frequently advocated for discontinuing specific pediatric vaccine recommendations in the US in order to be more in line with the Danish model, a nation with comprehensive healthcare and a number of inhabitants about the size of the state of Wisconsin.

To date comments, she has kept her attention on immunizations – traditionally the domain of Dr. Prasad, director of the FDA’s CBER – rather than drug regulation.

Concerns Over Qualifications

Høeg has no apparent background in drug development, oversight or leadership, which has been typical for previous heads of the biologics center. She has been employed at the FDA as a top consultant to the commissioner and the vaccine center since spring.

“It seems she lacks to have the requisite experience” for leading the drug-regulation department, said a neurologist and psychiatrist. “She has not conducted a clinical trial. She lacks experience in running a major agency. She has no expertise in drug approvals.”

Previous commissioners of CBER would “grasp laws and regulations and the science of medication creation”, said Dr. Janet Woodcock. “Frankly, she lacks the kind of background that previous people who led the center have had.”

The drug center has an immense range of responsibilities at the agency, the former commissioner stated.

“Everybody just zeroes in on the new drug program, but the generic drug division clears thousands of generic drugs. There’s a biosimilars division, OTC medication office and other areas, and all of those must be supervised,” Dr. Woodcock noted. “The thing you don’t keep your eye on, that is the part that I always told people is going to bite you.”

There is also, a major management component to the job, which oversees in excess of 5,000 personnel. “It’s a huge administrative position, if you do it right,” Woodcock added.

Response and Controversial Initiatives

When asked about concerns about Dr. Høeg's fitness for the role and whether this assignment signifies increased cooperation among regulatory chiefs on vaccines, a press secretary stated that the “questions rely on incorrect premises”.

“Her experience matches the functions of her job,” the representative stated, pointing to the time Dr. Høeg spent advising the FDA commissioner on “pharmaceutical safety and approval science, including predictive safety algorithms and vaccine surveillance”.

As the temporary head, Høeg assumes responsibility for the agency head's recently launched expedited review system, a controversial rapid drug-approval program that apparently worried her preceding directors. “By what process are these therapies being chosen for this fast-track system? Who is making the choices?” Dr. Howard questioned. “There is a lot of confidentiality going on at the FDA right now.”

Broadly speaking, he stated, “the Food and Drug Administration appears to be shifting towards laxer rules of most medications, except for vaccines.”

Public Track Record on Immunizations

Concerning immunizations, Dr. Høeg has a clearer, if troubling, track record, critics observe. She authored a research paper using unverified volunteer-provided data to determine the frequency of myocarditis after Covid immunization. She counseled the state of Florida chief medical officer Dr. Joseph Ladapo, who allegedly have modified findings to indicate COVID-19 vaccines are riskier than they are.

Included in her “desired changes” for the new federal leadership featured changing guidelines for recently developed shots and halting “optional” immunizations, she remarked following the vote on a audio program. At the agency, Høeg has according to sources proposed barring adolescent males from getting COVID-19 vaccines.

“She’s an all-around true believer who starts off with her conclusions and works backwards to fit the science in a very misleading, untruthful fashion,” Howard said.

Gaining Influence and a “Revenge Tour”

Dr. Høeg joined other contrarians, {like|