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While the US proceeds with historic changes to its vaccination recommendations, one figure has surfaced in a surprising turn: Tracy Beth Høeg, a Danish American physician and public health researcher who initially gained attention by casting doubt on Covid vaccinations in the pandemic and has focused upon potential deaths following Covid immunization in her short tenure at the Food and Drug Administration.

Scheduled Shifts to Pediatric Immunization Program

Public health authorities planned to reveal radical changes to the pediatric vaccine schedule in December, synchronizing the US with the Danish immunization schedule, sources say – a substantial departure that would put the US out of step with a large portion of the world with little proof for public health gain. The announcement has been postponed until the next year.

In place of the top vaccines chief, Tracy Beth Høeg is set to address the audience at the gathering. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to head the center this year.

A Shift at the Agency

Høeg's temporary position could signify a strengthened alliance between the drug and biologics branches as Høeg and Dr. Prasad strengthen their influence at the agency – and it signals a greater focus upon dismantling previously authorized vaccines at the FDA.

Høeg has repeatedly called for discontinuing specific pediatric shot schedules in the US so as to align more similar to the Danish model, a society with universal health coverage and a population approximately the size of the state of Wisconsin.

To date public appearances, she has continued to focus on vaccines – typically the domain of Dr. Prasad, director of the FDA’s CBER – as opposed to medication approval.

Questions Over Background

Høeg has little discernible background in medication creation, regulation or leadership, which has been customary for past heads of the biologics center. She has been employed at the FDA as a key advisor to the commissioner and CBER since earlier this year.

“It seems she lacks to have the necessary background” for running the pharmaceutical oversight division, remarked a neurologist and psychiatrist. “She lacks experience running a clinical trial. She has no expertise in managing a major agency. She is not an expert in drug approvals.”

Former commissioners of CBER would “grasp laws and regulations and the underlying principles of pharmaceutical innovation”, said Janet Woodcock. “Frankly, she doesn’t have the kind of background that prior appointees who headed CBER have had.”

CDER has an enormous portfolio at the FDA, Woodcock pointed out.

“Many people just pays attention on the new drug program, but the off-patent medication office approves thousands of off-brand pharmaceuticals. There is also a biosimilars division, over-the-counter program and other areas, and every single one have to be looked after,” she noted. “The thing you don’t keep your eye on, that is precisely what that I always told people is going to cause problems.”

Additionally, a substantial administrative aspect to the role, which manages in excess of 5,000 personnel. “It’s a huge administrative position, if you execute it properly,” she added.

Agency Reaction and Contentious Initiatives

In response to concerns about Høeg’s credentials and whether this selection signifies more teamwork among agency officials on immunizations, a spokesperson responded that the “concerns stem from inaccurate assumptions”.

“This background is consistent with the responsibilities of her role,” the representative explained, citing the time Dr. Høeg spent guiding the agency head on “drug safety and regulatory science, including computerized risk analysis and vaccine surveillance”.

As acting director, Dr. Høeg inherits the commissioner’s controversial expedited review system, a contentious rapid medication authorization process that apparently worried her predecessors. “How are these drugs being picked for this voucher program? Who is making the calls?” Dr. Howard asked. “There’s a lot of confidentiality going on at the FDA right now.”

Broadly speaking, he stated, “the FDA looks to be trending towards less stringent oversight of all drugs, with the exception of shots.”

Documented Past Work on Vaccines

Regarding immunizations, Dr. Høeg has a more documented, if problematic, past, Howard said. She released a research paper using unverified volunteer-provided data to assess the rate of myocarditis following COVID-19 immunization. She advised the state of Florida chief medical officer Joseph Ladapo, who reportedly have modified findings to suggest COVID-19 vaccinations are pose a greater threat than they are.

Among her “wish list” for the new federal leadership encompassed altering guidelines for new vaccines and discontinuing “unnecessary” vaccines, she remarked post-election on a podcast. At the agency, Dr. Høeg has according to sources floated the idea of preventing adolescent males from getting Covid vaccines.

“She’s an all-around true believer who starts off with her preconceived notions and reverse-engineers to fit the data in a very disingenuous, dishonest manner,” Howard stated.

Gaining Influence and a “Push for Payback”

Dr. Høeg joined fellow skeptics, {like|