FDA Blocks Publication of Studies Finding COVID-19 and Shingles Vaccines Safe
核心洞察
The FDA blocked publication of several taxpayer-funded studies that analyzed millions of patient records and found serious side effects from COVID-19 (搜索) and shingles (搜索) vaccines to be rare.
One COVID-19 (搜索) study examining 7.5 million Medicare beneficiaries found anaphylaxis (搜索) affecting roughly one in a million Pfizer vaccine (搜索) recipients as the only concerning outcome.
HHS officials stated the studies were withdrawn because authors drew broad conclusions not supported by underlying data, though former FDA officials suggest a pattern of suppressing vaccine safety information.
The US Food and Drug Administration has blocked the publication of several studies that found COVID-19 (搜索) and shingles (搜索) vaccines to be safe, according to a Department of Health and Human Services (搜索) spokesperson. The taxpayer-funded studies, costing several million dollars, analyzed millions of patient records and concluded that serious side effects from the vaccines were rare.
COVID-19 Vaccine Safety Studies Withdrawn
One of the blocked COVID-19 (搜索) studies examined vaccine safety in people over 65 by reviewing medical records of 7.5 million Medicare beneficiaries. Researchers focused on the 21-day period after vaccination and the subsequent 20 days, comparing rates of health issues immediately following vaccination.
The study assessed 14 potential outcomes, including heart attacks, strokes, and Guillain-Barré syndrome (搜索), a rare autoimmune disorder. Researchers found that anaphylaxis (搜索) was the only concerning outcome, affecting roughly one in a million people who received the Pfizer vaccine (搜索). The study stated: "No other statistically significant elevations in risk were observed."
Despite being accepted by Drug Safety, a peer-reviewed journal, the study was later withdrawn in October. Another withdrawn study examined COVID-19 (搜索) vaccine safety among 4.2 million people aged six months to 64 years, assessing more than a dozen health conditions including brain swelling, blood clots, and heart attacks. That study found rare cases of fever-related seizures and myocarditis (搜索), or heart muscle inflammation.
"Given the available evidence, FDA continues to conclude the benefits of vaccination outweigh the risks," the study stated.
Shingles Vaccine Research Also Blocked
In addition to the COVID-19 (搜索) studies, several shingles (搜索) vaccine studies were prevented from publication. Agency officials did not sign off in time in February for staff to submit abstracts on two Shingrix studies to a drug safety conference.
Official Response and Criticism
Andrew Nixon, an HHS spokesperson, confirmed the withdrawals in a statement: "The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data. The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards."
Regarding the shingles (搜索) vaccine research, Nixon said the design of that study "fell outside the agency's purview."
However, former FDA officials have criticized these decisions. Janet Woodcock, the former FDA principal deputy commissioner, said that "there is a pattern here for not letting information out that might support the general safety of vaccines, with methodological rationales given by non-scientist spokespersons."
Dorit Reiss, a law professor at UC Law San Francisco who focuses on vaccine-related legal and policy issues, noted: "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."
Administrative Context
The decision to halt the studies' publications occurred under the Trump administration's HHS Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic who has implemented various measures to challenge vaccine access. Under his leadership, federal health agencies have softened COVID shot recommendations, cut back research on vaccine development, and attempted to overhaul the childhood immunization schedule.
The decision to block these studies did not reach FDA Commissioner Marty Makary or HHS Secretary Robert F. Kennedy Jr., according to reports. Meanwhile, FDA employees have raised concerns about management under Makary's leadership, with reports of frequent clashes with administration officials and biotech firms expressing disillusionment with what they view as an inconsistent drug review process.