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While the US continues making sweeping revisions to its immunization recommendations, one figure has emerged unexpectedly: Høeg, a Danish American sports medicine doctor and public health researcher who initially gained attention by casting doubt on COVID-19 vaccines in the pandemic and has focused upon alleged deaths after Covid immunization in her brief position at the Food and Drug Administration.

Scheduled Overhauls to Pediatric Vaccine Schedule

Public health authorities had intended to announce major revisions to the childhood vaccine schedule earlier this month, aligning the US with Denmark’s national calendar, sources say – a substantial departure that would put the US out of step with much of the world with little proof for benefit. This reveal has been postponed until the new year.

Instead of the director of the vaccine center, Dr. Høeg is listed to speak at the event. She was newly appointed temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth individual to head the office this year.

A New Direction at the Regulatory Body

Høeg's temporary position may indicate a closer partnership between the pharmaceutical and biologics centers as Dr. Høeg and Dr. Prasad solidify control at the regulatory agency – and it signals a increased emphasis upon reevaluating already-approved vaccines at the FDA.

Dr. Høeg has often pushed for ending certain childhood shot schedules in the US in order to be more like the Danish model, a country with universal health coverage and a number of inhabitants about the population of the state of Wisconsin.

To date public appearances, she has kept her attention on immunizations – usually the responsibility of Prasad, head of the FDA’s vaccine center – rather than medication approval.

Doubts Over Qualifications

Høeg has no obvious background in drug development, approval processes or administrative roles, which has been customary for past heads of the CBER. She has worked at the FDA as a senior adviser to the commissioner and CBER since spring.

“She appears not to have the requisite experience” for leading the pharmaceutical oversight division, said a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She lacks experience in running a large organization. She lacks background in pharmaceutical oversight.”

Previous commissioners of CBER would “understand regulatory frameworks and the underlying principles of medication creation”, noted Janet Woodcock. “Frankly, she doesn’t have the kind of background that former directors who headed CBER have had.”

CDER has an immense portfolio at the FDA, she emphasized.

“Many people just pays attention 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 other areas, and each of these need to be looked after,” Dr. Woodcock explained. “The area you overlook, that is precisely what that I always told people is going to cause problems.”

Additionally, a significant administrative component to the job, which manages in excess of 5,000 personnel. “It’s a huge management job, if you perform it correctly,” she concluded.

Response and Controversial Policies

Regarding concerns about Høeg’s qualifications and whether this selection signifies more teamwork among agency officials on immunizations, a press secretary responded that the “concerns stem from incorrect premises”.

“Her resume aligns with the duties of her position,” the spokesperson said, pointing to the time Høeg spent counseling the agency head on “medication safety and regulatory science, including predictive safety algorithms and vaccine surveillance”.

In her interim role, Høeg assumes responsibility for the commissioner’s new fast-track approval initiative, a contentious rapid drug-approval program that allegedly worried her predecessors. “How are these therapies being selected for this fast-track system? Who is making the calls?” Dr. Howard questioned. “There is a lot of confidentiality going on at the FDA right now.”

Broadly speaking, he remarked, “the FDA appears to be shifting towards laxer rules of all drugs, aside from immunizations.”

Established Past Work on Immunizations

Regarding vaccines, Høeg has a more established, if troubling, track record, critics have noted. She released a analysis using unverified public submissions to estimate the frequency of myocarditis after COVID-19 immunization. She consulted for the Florida surgeon general Joseph Ladapo, who allegedly have altered data to indicate Covid vaccinations are pose a greater threat than they are.

Included in her “desired changes” for the new administration encompassed changing rules for new vaccines and discontinuing “non-essential” immunizations, she remarked following the vote on a audio program. At the agency, Dr. Høeg has allegedly floated the idea of barring young men from getting COVID-19 vaccines.

“She’s an complete ideologue who begins with her beliefs and reverse-engineers to fit the science in a highly disingenuous, untruthful fashion,” Dr. Howard argued.

Gaining Influence and a “Push for Payback”

Høeg became part of fellow skeptics, {like|