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As America continues making sweeping revisions to its vaccine guidelines, a particular individual has emerged unexpectedly: Høeg, an American of Danish descent sports physician and public health researcher who rose to prominence by questioning COVID-19 vaccinations during the pandemic and has zeroed in on potential fatalities after Covid vaccination in her brief time at the FDA.

Scheduled Overhauls to Childhood Vaccine Schedule

Health officials planned to reveal major changes to the pediatric immunization program recently, synchronizing the US with Denmark’s national calendar, it is understood – a substantial departure that would put the US out of alignment with much of the global community with insufficient data for benefit. The planned update has been postponed until the next year.

In place of the top vaccines chief, Høeg is listed to address the audience at the meeting. She was recently named interim head of the FDA’s CDER, the fifth person to run the center this year.

Consolidating Power at the Agency

The acting appointment could signify a closer partnership between the pharmaceutical and biologics divisions as Dr. Høeg and Dr. Prasad consolidate power at the regulatory agency – and it suggests a greater focus upon rolling back already-approved vaccines at the FDA.

The new acting director has often pushed for halting some childhood immunization guidelines in the US so as to align more like Denmark's approach, a country with universal health coverage and a citizenry about the size of Wisconsin’s.

To date statements, she has kept her attention on vaccination policy – traditionally the responsibility of Prasad, director of the FDA’s CBER – as opposed to pharmaceutical oversight.

Doubts Over Background

Høeg has little discernible experience in pharmaceutical research, oversight or leadership, which has been typical for previous leaders of the CBER. She has worked at the FDA as a senior adviser to the commissioner and the vaccine center since March.

“She appears not to have the necessary background” for running the pharmaceutical oversight division, stated a neurologist and psychiatrist. “She has not conducted a scientific study. She has no expertise in leading a sizeable institution. She has no expertise in pharmaceutical oversight.”

Previous commissioners of CBER would “understand laws and regulations and the underlying principles of medication creation”, said Dr. Janet Woodcock. “Objectively, she doesn’t have the kind of background that prior appointees who headed the center have had.”

CDER has an vast portfolio at the agency, the former commissioner emphasized.

“The public just pays attention on the novel medication approvals, but the generic program approves thousands of off-brand pharmaceuticals. There’s a biologic copycat branch, over-the-counter program and other areas, and each of these need to be looked after,” she explained. “The responsibility you neglect, that is precisely what that I always told people is going to bite you.”

Additionally, a substantial administrative component to the role, which supervises over 5,000 personnel. “It’s a huge management job, if you do it right,” the former official concluded.

Agency Reaction and Disputed Policies

When asked about questions about Høeg’s fitness for the role and whether this assignment indicates greater collaboration among FDA leaders on vaccines, a spokesperson responded that the “concerns are based on inaccurate assumptions”.

“Her resume matches the responsibilities of her job,” the representative explained, noting the time Høeg spent advising the FDA commissioner on “drug safety and approval science, including computational safety modeling and vaccine surveillance”.

As acting director, Høeg assumes responsibility for the agency head's new priority voucher program, a controversial expedited therapy clearance system that allegedly troubled her former heads. “By what process are these therapies being picked for this fast-track system? Who makes the choices?” Dr. Howard said. “There’s a lot of secrecy going on at the agency right now.”

In general, he said, “the FDA seems to be moving towards more relaxed rules of pharmaceuticals, except for vaccines.”

Public History on Vaccines

Concerning immunizations, Høeg has a more documented, if troubling, past, critics have noted. She authored a study using non-validated volunteer-provided data to determine the incidence of myocarditis following COVID-19 immunization. She consulted for the state of Florida surgeon general Joseph Ladapo, who reportedly have modified findings to suggest COVID-19 vaccines are pose a greater threat than they are.

Included in her “wish list” for the current federal leadership included altering guidelines for new vaccines and halting “unnecessary” immunizations, she remarked after the election on a online show. At the FDA, Høeg has according to sources suggested preventing young men from obtaining COVID-19 vaccines.

“She’s an complete ideologue who commences with her beliefs and reverse-engineers to retrofit the data in a very deceptive, dishonest manner,” Howard stated.

Taking Control and a “Push for Payback”

Høeg joined fellow skeptics, {like|