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Given that America undertakes sweeping revisions to its vaccine schedules, a particular individual has emerged in a surprising turn: Høeg, a Danish American sports medicine doctor and epidemiologist who rose to prominence by expressing skepticism about coronavirus vaccinations throughout the pandemic and has zeroed in on potential deaths after Covid immunization in her brief position at the Food and Drug Administration.

Planned Changes to Childhood Vaccine Schedule

Health officials were set to unveil major changes to the pediatric immunization program in December, bringing the US with the Danish vaccine program, according to reports – a significant shift that would put the US out of alignment with many the global community with no evidence for benefit. This reveal has been postponed until the coming year.

Rather than the director of the vaccine center, Høeg is scheduled to address the audience at the event. She was just designated interim head of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to lead the division this year.

A New Direction at the Agency

The acting appointment might represent a strengthened alliance between the pharmaceutical and biologics centers as Høeg and Prasad solidify control at the FDA – and it suggests a renewed priority upon rolling back long-standing immunizations at the FDA.

Høeg has repeatedly called for halting certain childhood vaccine recommendations in the US to become more similar to Denmark's approach, a society with nationalized medicine and a citizenry about the size of the state of Wisconsin.

To date comments, she has continued to focus on vaccination policy – typically the responsibility of Prasad, director of the FDA’s vaccine center – as opposed to drug regulation.

Doubts Over Qualifications

Høeg has no obvious background in drug development, regulation or management, which has been typical for past leaders of the Center for Biologics Evaluation and Research. She has worked at the FDA as a top consultant to the agency head and the vaccine center since earlier this year.

“It seems she lacks to have the necessary background” for running the drug-regulation department, stated Dr. Jonathan Howard. “She lacks experience running a scientific study. She has no expertise in running a large organization. She has no expertise in pharmaceutical oversight.”

Former heads of CBER would “understand regulatory frameworks and the research of drug development”, noted Janet Woodcock. “Clearly, she doesn’t have the sort of resume that previous people who ran the center have had.”

This division has an immense portfolio at the FDA, the former commissioner pointed out.

“Many people just zeroes in on the novel medication approvals, but the off-patent medication office approves thousands of generic drugs. There’s a biologic copycat branch, over-the-counter program and more, and each of these need to be managed,” Dr. Woodcock explained. “The area you don’t keep your eye on, that is precisely what that I always told people is going to come back to haunt you.”

Additionally, a significant management aspect to the job, which supervises more than 5,000 staff members. “It is a huge management job, if you do it right,” Woodcock concluded.

Official Statement and Disputed Policies

Regarding questions about Høeg’s qualifications and whether this appointment signifies more teamwork among regulatory chiefs on immunizations, a representative stated that the “concerns rely on incorrect presumptions”.

“Her experience matches the duties of her role,” the spokesperson stated, noting the period Dr. Høeg spent guiding the agency head on “medication safety and approval science, including predictive safety algorithms and shot safety tracking”.

As the temporary head, Dr. Høeg takes over the agency head's controversial expedited review system, a controversial rapid drug-approval program that allegedly concerned her former heads. “By what process are these therapies being chosen for this expedited pathway? Who is making the decisions?” Howard asked. “There is a lot of lack of transparency occurring at the agency right now.”

Broadly speaking, he stated, “the agency seems to be moving towards less stringent rules of most medications, except for vaccines.”

Established Track Record on Vaccines

Concerning immunizations, Dr. Høeg has a clearer, if troubling, history, some experts observe. She published a study using non-validated public submissions to determine the frequency of myocarditis following COVID-19 vaccination. She advised the state of Florida surgeon general Joseph Ladapo, who reportedly have modified findings to indicate Covid vaccines are pose a greater threat than they are.

Part of her “wish list” for the new federal leadership encompassed altering rules for novel immunizations and ending “optional” immunizations, she said after the election on a podcast. At the FDA, Dr. Høeg has reportedly suggested barring adolescent males from getting Covid vaccinations.

“She’s an all-around dogmatist who starts off with her beliefs and reverse-engineers to fit the data in a very misleading, fraudulent manner,” Dr. Howard argued.

Taking Control and a “Push for Payback”

Høeg became part of other skeptics, {like|