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The Food and Drug Administration (FDA) has blocked the release of multiple studies demonstrating the safety of vaccinations for coronavirus and shingles, a move that some health experts are saying amounts to censorship.
Officials within the Department of Health and Human Services (HHS) have confirmed that the studies were blocked from publication.
The three studies in question — which cost millions of dollars and were conducted by agency-based scientists — found that serious side effects from the vaccines for COVID and shingles were very rare.
In one study, reviewing the records of 7.5 million Medicare recipients who received COVID vaccines, researchers sought to examine 14 potential health outcomes to determine if the shots could lead to them. Only one health concern was observed — the possibility of anaphylaxis, an allergic reaction that only affects 1 in 1 million people.
“No other statistically significant elevations in risk were observed,” the study concluded.
The second COVID-based study examined 4.2 million records of vaccine recipients, searching for concerns with 17 potential conditions. Researchers found that “the benefits of vaccination outweigh the risks,” according to their study’s conclusion.
The scientists were ordered to withdraw two COVID vaccine studies in October. Agency officials refused to sign off on the shingles study for publication in February.
HHS spokesperson Andrew Nixon claimed the studies were nixed from publication due to errors by researchers in determining their findings.
“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data,” Nixon said.
But health experts examining the studies separately say they did not appear to be unusual or unworthy of publication.
Caleb Alexander, a drug safety and methodology expert at Johns Hopkins University, told The New York Times that “there is nothing inherently problematic regarding these reports” after he personally reviewed them. He added that the reports would provide “useful information regarding the most commonly used COVID-19 vaccines.”
Aaron S. Kesselheim, a Harvard medical professor who studies FDA regulation, also told The Times that the decision to block the studies was deeply problematic. According to Kesselheim, research papers the agency produces generally meet “the highest standards of scientific investigation.” The move to pull the studies from publication was an act of “censorship,” he added.
“At any other time in history, this would be a major scandal that would lead to congressional hearings and resignations of leadership, and I hope that’s what happens next,” Kesselheim said.
These allegations of censorship come just a month after the Centers for Disease Control and Prevention (CDC) was accused of blocking a separate report from being published, showcasing the efficacy of COVID shots. That report had cleared the CDC’s strict review process, but was initially delayed by then-acting CDC director Jay Bhattacharya, who claimed he had concerns over methodology. After initially delaying the study, the CDC later decided not to publish it at all.
“The same methodology has long been used by the CDC to evaluate vaccine effectiveness for respiratory viruses and was used in a study on the flu vaccine,” an analysis published by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota pointed out.
The delay and blocking of vaccine-related studies from being published comes as HHS has taken multiple anti-vaccine actions.
Despite the proven effectiveness and safety of mRNA vaccines, HHS announced last summer that it was winding down the development of such vaccines, canceling 22 federal projects worth around $500 million.
“This undermining of public confidence in and federal funding for mRNA research is really going to set us back,” said Bill Moss, executive director of the International Vaccine Access Center at Johns Hopkins University, in an interview last year. “Other countries will move forward and we will be stalled.”
A CDC-based vaccine advisory panel — comprised mostly of vaccine skeptics appointed by Robert F. Kennedy Jr. last year — also voted in December to reduce the childhood vaccine schedule, which is used across the U.S. as a recommendation to health care providers on what vaccines kids should receive and when.
The alteration of the childhood vaccine schedule was reportedly made to align the U.S. with similar vaccine schedules used in Europe. Experts say that such a move doesn’t make sense, as different countries have separate health needs and challenges.
“Public health is not one size fits all. It’s population-specific and dynamic,” said Anders Hviid of Denmark’s Statens Serum Institute at the time.
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