FDA's Shocking Block on Vaccine Safety Studies: What Are They Hiding from You?

The U.S. Food and Drug Administration (FDA) has recently blocked the publication of several key studies that found both Covid-19 and shingles vaccines to be safe, according to Andrew Nixon, a spokesperson from the Department of Health and Human Services (HHS). This decision has raised concerns among health experts and advocates who question the motivations behind withholding such findings.

The FDA's scientists conducted extensive research analyzing millions of patient records, concluding that serious side effects from these vaccines are rare. These studies, funded by taxpayer money at a cost of several million dollars, included investigations into the safety of Covid-19 vaccines for 2023 and 2024.

Nixon explained that the studies were withdrawn because the authors "drew broad conclusions that were not supported by the underlying data." He emphasized that the FDA acted to protect the integrity of its scientific process, ensuring that any work associated with the agency adheres to its high standards.

One prominent Covid-19 study examined vaccine safety among people aged 65 and older by reviewing medical records from 7.5 million Medicare beneficiaries. Researchers focused on the health outcomes during the 21 days following vaccination and an additional 20 days, assessing 14 potential health issues, including heart attacks, strokes, and Guillain-Barré syndrome, a rare autoimmune disorder. The study noted that anaphylaxis was the only concerning outcome, affecting roughly one in a million recipients of the Pfizer vaccine. Despite being accepted by *Drug Safety*, a peer-reviewed journal, this study was later withdrawn, according to sources familiar with the matter.

Dorit Reiss, a law professor at UC Law San Francisco specializing in vaccine-related legal and policy issues, remarked, "The fact that in one case these were accepted by a journal and that they are open about not liking the conclusion makes it more jarring." This sentiment reflects a broader unease regarding the transparency of vaccine safety data.

Janet Woodcock, former principal deputy commissioner of the FDA, noted a troubling trend regarding the suppression of data that could affirm the general safety of vaccines. She implied that methodological rationales provided by non-scientist spokespersons, such as Nixon, often undermine public confidence in vaccine safety.

In addition to the Covid-19 studies, several shingles-related studies were also blocked from publication. Reports indicate that agency officials failed to sign off in time for the submission of abstracts related to two Shingrix studies intended for a drug safety conference. Nixon maintained that "the design of that study fell outside the agency’s purview." Notably, the decision to halt these publications did not reach FDA Commissioner Marty Makary or HHS Secretary Robert F. Kennedy Jr.

This news comes amidst growing scrutiny of the HHS and its leadership. Kennedy has been criticized for his anti-vaccine rhetoric, which many argue has affected funding and accessibility to Covid-19 vaccines and other essential immunizations. Reports suggest that employees at the FDA have expressed concerns about management under Makary’s leadership, citing frequent clashes with administration officials and a perception of an inconsistent drug review process among biotech firms.

Angela Rasmussen, editor-in-chief of the journal *Vaccine*, confirmed to the *New York Times* that the second study looking at Covid-19 vaccine safety among 4.2 million individuals aged six months to 64 years was also withdrawn by its authors. That study assessed over a dozen health conditions, including brain swelling, blood clots, and heart attacks, noting rare cases of fever-related seizures and myocarditis, or heart muscle inflammation.

Despite the withdrawal of these studies, the FDA continues to assert that the benefits of vaccination significantly outweigh the risks. This situation underscores the continuing debate over vaccine safety and the transparency of health data in the U.S., raising important questions about public trust in health institutions.