🔗 Share this article

Given that America undertakes sweeping adjustments to its immunization guidelines, a particular individual has emerged somewhat surprisingly: Høeg, a US-based sports medicine doctor and epidemiologist who initially gained attention by expressing skepticism about COVID-19 vaccinations in the global health crisis and has zeroed in on alleged deaths after COVID-19 vaccination in her brief time at the US Food and Drug Administration (FDA).

Planned Shifts to Pediatric Immunization Schedule

Agency leaders planned to announce major revisions to the childhood vaccination calendar earlier this month, bringing the US with the Danish immunization schedule, according to reports – a significant shift that would put the US out of step with a large portion of the international standard with no evidence for public health gain. This reveal has been pushed back until the coming year.

Instead of Vinay Prasad, Høeg is set to speak at the event. She was newly appointed interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to run the office this year.

Consolidating Power at the Agency

Høeg's temporary position could signify a tighter collaboration between the drug and biologics branches as Høeg and Prasad solidify control at the FDA – and it signals a greater focus upon reevaluating previously authorized vaccines at the FDA.

The new acting director has repeatedly called for discontinuing certain pediatric vaccine recommendations in the US so as to align more like the Danish model, a country with comprehensive healthcare and a citizenry about the size of Wisconsin’s.

To date statements, she has continued to focus on immunizations – traditionally the responsibility of Dr. Prasad, chief of the FDA’s vaccine center – instead of drug regulation.

Concerns Over Background

Høeg has little discernible track record in pharmaceutical research, regulation or management, which has been standard for previous heads of the Center for Biologics Evaluation and Research. She has worked at the FDA as a senior adviser to the FDA chief and the vaccine center since March.

“She doesn’t seem to have any of the qualifications” for running the pharmaceutical oversight division, stated Dr. Jonathan Howard. “She has not conducted a randomized controlled trial. She is not versed in managing a major agency. She is not an expert in drug approvals.”

Former heads of the center would “understand regulatory frameworks and the underlying principles of drug development”, commented a former acting FDA commissioner. “Objectively, she lacks the sort of resume that former directors who headed CBER have had.”

CDER has an enormous workload at the agency, Woodcock pointed out.

“Everybody just focuses on the new drug program, but the generic drug division authorizes a multitude of generic drugs. There’s a biologic copycat branch, OTC medication office and so forth, and all of those need to be looked after,” she noted. “The thing you overlook, that is precisely what that I always told people is going to cause problems.”

There is also, a significant administrative component to the role, which manages in excess of 5,000 personnel. “It’s a huge management job, if you perform it correctly,” Woodcock said.

Response and Controversial Policies

When asked about inquiries about Dr. Høeg's credentials and whether this selection represents more teamwork among regulatory chiefs on vaccines, a press secretary stated that the “inquiries stem from inaccurate presumptions”.

“Her experience aligns with the functions of her job,” the spokesperson stated, noting the time Høeg spent guiding the FDA commissioner on “medication safety and regulatory science, including predictive safety algorithms and vaccine surveillance”.

As acting director, Dr. Høeg takes over the commissioner’s new fast-track approval initiative, a disputed one-day drug-approval program that allegedly worried her preceding directors. “How are these medications being selected for this voucher program? Who takes the decisions?” Dr. Howard asked. “There’s a lot of lack of transparency happening at the regulatory body right now.”

Overall, he remarked, “the agency looks to be trending towards laxer rules of pharmaceuticals, with the exception of vaccines.”

Documented Past Work on Vaccines

Concerning immunizations, Høeg has a more established, if problematic, past, critics said. She published a study using unverified crowd-sourced reports to determine the rate of myocarditis following COVID-19 immunization. She advised the Florida chief medical officer Dr. Joseph Ladapo, who allegedly have changed statistics to imply Covid vaccinations are pose a greater threat than they are.

Included in her “desired changes” for the current government encompassed revising regulations for new vaccines and discontinuing “non-essential” vaccines, she said post-election on a online show. At the FDA, Dr. Høeg has reportedly floated the idea of preventing teenage boys from getting COVID-19 vaccines.

“She’s an all-around true believer who begins with her conclusions and reverse-engineers to retrofit the science in a very misleading, dishonest way,” Dr. Howard stated.

Consolidating Power and a “Revenge Tour”

Høeg aligned with fellow contrarians, {like|