🔗 Share this article

As the United States continues making unprecedented revisions to its immunization recommendations, a particular individual appears in a surprising turn: Høeg, a Danish American sports physician and public health researcher who initially gained attention by casting doubt on COVID-19 shots throughout the pandemic and has focused upon possible fatalities after Covid immunization in her brief position at the Food and Drug Administration.

Planned Overhauls to Childhood Immunization Schedule

Public health authorities were set to announce radical revisions to the pediatric vaccine schedule in December, bringing the US with Denmark’s vaccine program, according to reports – a significant shift that would place the US out of alignment with many the world with insufficient data for improved outcomes. This reveal has been delayed until the coming year.

Instead of Vinay Prasad, Dr. Høeg is scheduled to present at the meeting. She was newly appointed acting director of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to lead the office this calendar year.

Consolidating Power at the Agency

The acting appointment could signify a closer partnership between the drug and vaccine branches as Høeg and Dr. Prasad solidify control at the FDA – and it signals a greater focus upon rolling back long-standing immunizations at the FDA.

Høeg has repeatedly called for halting certain childhood immunization guidelines in the US to become more in line with Denmark's approach, a country with comprehensive healthcare and a population approximately the population of Wisconsin’s.

In her initial public appearances, she has kept her attention on vaccines – traditionally the responsibility of Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER) – as opposed to pharmaceutical oversight.

Questions Over Expertise

The appointee has no obvious experience in drug development, regulation or management, which has been typical for past leaders of the biologics center. She has been employed at the FDA as a key advisor to the commissioner and CBER since earlier this year.

“She doesn’t seem to have any of the qualifications” for overseeing the pharmaceutical oversight division, stated a neurologist and psychiatrist. “She has not conducted a scientific study. She has no expertise in running a sizeable institution. She has no expertise in industry regulation.”

Previous heads of CBER would “understand regulatory frameworks and the science of medication creation”, commented Dr. Janet Woodcock. “Clearly, she lacks the sort of resume that previous people who led CBER have had.”

CDER has an immense range of responsibilities at the agency, she emphasized.

“Many people just zeroes in on the innovative therapies, but the off-patent medication office approves numerous generic medications. There’s a biologic copycat branch, over-the-counter program and more, and every single one need to be supervised,” Dr. Woodcock said. “The thing you neglect, that’s the thing that I always told people is going to come back to haunt you.”

Additionally, a significant leadership aspect to the position, which manages more than 5,000 employees. “It’s a huge management job, if you do it right,” Woodcock said.

Response and Contentious Policies

In response to questions about Dr. Høeg's fitness for the role and whether this assignment indicates more teamwork among FDA leaders on immunizations, a spokesperson said that the “inquiries are based on incorrect assumptions”.

“Her resume matches the duties of her position,” the spokesperson stated, noting the period Høeg spent counseling the agency head on “drug safety and oversight research, including predictive safety algorithms and vaccine surveillance”.

As acting director, Høeg takes over the commissioner’s recently launched fast-track approval initiative, a contentious rapid drug-approval program that reportedly worried her preceding directors. “By what process are these drugs being selected for this voucher program? Who takes the calls?” Dr. Howard questioned. “There is a lot of secrecy going on at the regulatory body right now.”

Broadly speaking, he remarked, “the agency looks to be trending towards more relaxed regulations of most medications, except for vaccines.”

Established Track Record on Vaccines

Regarding vaccines, Høeg has a more established, if problematic, history, Howard have noted. She released a research paper using unverified volunteer-provided data to estimate the incidence of heart inflammation following Covid vaccination. She consulted for the state of Florida chief medical officer Dr. Joseph Ladapo, who allegedly have changed statistics to indicate Covid vaccines are riskier than they are.

Among her “policy goals” for the new federal leadership featured altering regulations for novel immunizations and discontinuing “optional” vaccines, she remarked post-election on a online show. At the agency, Høeg has allegedly floated the idea of barring young men from receiving COVID-19 vaccines.

“She is an complete true believer who starts off with her conclusions and works backwards to fit the science in a extremely disingenuous, dishonest manner,” Dr. Howard said.

Consolidating Power and a “Revenge Tour”

Høeg joined fellow contrarians, {like|