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While the US proceeds with historic revisions to its vaccine recommendations, one figure has surfaced unexpectedly: Tracy Beth Høeg, a US-based sports physician and public health researcher who initially gained attention by questioning COVID-19 shots throughout the pandemic and has zeroed in on possible fatalities following Covid vaccination in her brief tenure at the FDA.

Scheduled Shifts to Pediatric Vaccine Program

Public health authorities were set to announce radical changes to the childhood vaccination calendar in December, bringing the US with Denmark’s immunization schedule, sources say – a substantial departure that would put the US out of step with much of the global community with insufficient data for improved outcomes. This reveal has been postponed until the next year.

Rather than the top vaccines chief, Høeg is scheduled to address the audience at the gathering. She was just designated temporary leader of the FDA’s drug evaluation center, the fifth appointee to head the division this calendar year.

A New Direction at the FDA

Høeg's temporary position may indicate a strengthened alliance between the drug and vaccine divisions as Dr. Høeg and Dr. Prasad consolidate power at the agency – and it points to a renewed priority upon dismantling already-approved vaccines at the FDA.

Dr. Høeg has repeatedly called for discontinuing certain pediatric vaccine recommendations in the US so as to align more in line with the Danish model, a nation with comprehensive healthcare and a citizenry approximately the size of the state of Wisconsin.

So far public appearances, she has continued to focus on vaccination policy – typically the responsibility of Prasad, head of the FDA’s CBER – as opposed to medication approval.

Questions Over Expertise

The appointee has no apparent track record in pharmaceutical research, oversight or administrative roles, which has been typical for former leaders of the Center for Biologics Evaluation and Research. She has been employed at the FDA as a senior adviser to the FDA chief and the vaccine center since spring.

“She appears not to have any of the qualifications” for overseeing the CDER, remarked Jonathan Howard. “She’s never run a clinical trial. She is not versed in managing a sizeable institution. She lacks background in drug approvals.”

Former directors of CBER would “grasp regulatory frameworks and the research of pharmaceutical innovation”, commented Janet Woodcock. “Objectively, she doesn’t have the sort of resume that former directors who headed CBER have had.”

This division has an vast range of responsibilities at the FDA, she pointed out.

“Everybody just pays attention on the new drug program, but the off-patent medication office authorizes thousands of generic drugs. There is also a biosimilars division, OTC medication office and more, and each of these need to be supervised,” Dr. Woodcock said. “The thing you neglect, that’s the thing that I always told people is going to bite you.”

Furthermore, a major leadership element to the role, which manages more than 5,000 staff members. “It’s a huge administrative position, if you do it right,” she added.

Official Statement and Controversial Policies

When asked about inquiries about Høeg’s qualifications and whether this appointment represents more teamwork among regulatory chiefs on immunizations, a press secretary responded that the “inquiries are based on flawed premises”.

“Her resume aligns with the functions of her job,” the representative stated, citing the period Dr. Høeg spent counseling the FDA commissioner on “pharmaceutical safety and oversight research, including computational safety modeling and vaccine surveillance”.

As acting director, Høeg inherits the agency head's recently launched expedited review system, a controversial rapid drug-approval program that apparently concerned her former heads. “How are these drugs being chosen for this expedited pathway? Who makes the calls?” Dr. Howard asked. “There is a lot of lack of transparency going on at the FDA right now.”

Overall, he remarked, “the Food and Drug Administration seems to be moving towards less stringent regulations of most medications, aside from immunizations.”

Documented Track Record on Vaccines

Regarding immunizations, Høeg has a clearer, if concerning, track record, Howard said. She published a study using non-validated public submissions to assess the frequency of heart inflammation after Covid vaccination. She consulted for the Florida top health official Joseph Ladapo, who reportedly have changed statistics to suggest COVID-19 vaccines are pose a greater threat than they are.

Included in her “wish list” for the current federal leadership encompassed changing guidelines for novel immunizations and ending “unnecessary” vaccines, she stated following the vote on a online show. At the agency, Dr. Høeg has according to sources floated the idea of barring young men from obtaining COVID-19 vaccines.

“She is an complete true believer who commences with her conclusions and reverse-engineers to fit the data in a highly deceptive, dishonest manner,” Dr. Howard stated.

Consolidating Power and a “Revenge Tour”

Høeg became part of fellow dissenters, {like|