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As America continues making unprecedented changes to its immunization guidelines, a particular individual has surfaced in a surprising turn: Høeg, a Danish American sports medicine doctor and public health researcher who initially gained attention by questioning coronavirus shots throughout the pandemic and has focused upon possible fatalities following Covid immunization in her short position at the Food and Drug Administration.

Planned Overhauls to Childhood Immunization Program

Health officials planned to announce sweeping changes to the childhood vaccination calendar earlier this month, aligning the US with the Danish vaccine program, according to reports – a substantial departure that would place the US out of step with many the world with no evidence for improved outcomes. The planned update has been pushed back until the new year.

Rather than the director of the vaccine center, Dr. Høeg is listed to address the audience at the gathering. She was just designated temporary leader of the FDA’s drug evaluation center, the fifth person to head the division this year.

A Shift at the Agency

The acting appointment might represent a strengthened alliance between the drug and biologics branches as Høeg and Dr. Prasad strengthen their influence at the regulatory agency – and it points to a greater focus upon reevaluating previously authorized vaccines at the FDA.

Dr. Høeg has often pushed for halting some childhood immunization guidelines in the US in order to be more similar to Denmark, a country with comprehensive healthcare and a number of inhabitants about the size of the state of Wisconsin.

To date public appearances, she has persisted in emphasizing on vaccination policy – traditionally the domain of Prasad, head of the FDA’s vaccine center – as opposed to drug regulation.

Doubts Over Expertise

The appointee has no obvious background in pharmaceutical research, oversight or management, which has been standard for former directors of the biologics center. She has served at the FDA as a top consultant to the FDA chief and CBER since spring.

“She doesn’t seem to have the requisite experience” for leading the drug-regulation department, said Jonathan Howard. “She’s never run a randomized controlled trial. She is not versed in running a major agency. She is not an expert in pharmaceutical oversight.”

Previous directors of CBER would “understand laws and regulations and the research of drug development”, noted Janet Woodcock. “Objectively, she has not acquired the type of experience that prior appointees who led CBER have had.”

This division has an immense range of responsibilities at the FDA, Woodcock stated.

“Many people just focuses on the innovative therapies, but the generic drug division clears thousands of generic medications. There’s a biosimilars program, OTC medication office and more, and each of these have to be managed,” Woodcock said. “The area you overlook, that is the part that I always told people is going to bite you.”

Furthermore, a substantial administrative aspect to the role, which manages over 5,000 employees. “It’s a massive leadership role, if you execute it properly,” the former official said.

Agency Reaction and Controversial Programs

Regarding concerns about Dr. Høeg's fitness for the role and whether this assignment represents more teamwork among regulatory chiefs on immunizations, a spokesperson said that the “questions are based on inaccurate assumptions”.

“Her resume aligns with the functions of her job,” the official explained, noting the period Dr. Høeg spent counseling the agency head on “pharmaceutical safety and approval science, including computational safety modeling and vaccine surveillance”.

As the temporary head, Høeg takes over the agency head's new expedited review system, a disputed expedited drug-approval program that reportedly worried her preceding directors. “How are these drugs being selected for this expedited pathway? Who takes the decisions?” Howard asked. “There’s a lot of secrecy going on at the agency right now.”

Broadly speaking, he stated, “the FDA seems to be moving towards less stringent regulations of all drugs, with the exception of vaccines.”

Documented Past Work on Immunizations

Concerning immunizations, Høeg has a more documented, if problematic, past, some experts said. She published a research paper using unverified public submissions to determine the incidence of myocarditis following COVID-19 immunization. She consulted for the state of Florida top health official Dr. Joseph Ladapo, who allegedly have modified findings to imply Covid vaccines are pose a greater threat than they are.

Included in her “wish list” for the incoming government included altering regulations for new vaccines and ending “optional” immunizations, she said after the election on a podcast. At the agency, Dr. Høeg has allegedly proposed excluding young men from getting Covid vaccinations.

“She is an thorough dogmatist who commences with her preconceived notions and reverse-engineers to retrofit the data in a very misleading, fraudulent way,” Howard said.

Gaining Influence and a “Push for Payback”

Høeg joined fellow dissenters, {like|