US FDA blocked publication of COVID, shingles vaccine safety studies

FDA official says the studies were pulled over concerns about their conclusions

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, Aug 29, 2020. REUTERS

Officials at the USFood and Drug Administration blocked the publication of several studies supporting the safety of widely used ‌vaccines against COVID-19 and shingles, a Department of Health and Human Services spokesperson said.

Andrew Nixon, a spokesman for the Department of Health and Human Services, which oversees the FDA, said the studies were pulled over concerns about their conclusions.

"The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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," he said in an email to Reuters.

The withdrawal of these studies is the latest attempt by the health regulator and the administration to limit access to vaccines, reflecting broader policy changes under USHealth Secretary Robert F Kennedy Jr, a staunch critic of vaccines.

The Trump administration has sharply ‌reduced funding for vaccine research and raised questions about vaccine safety and effectiveness under the tenure of Kennedy, who has introduced sweeping changes across federal health agencies.

In August last year, the US Department of Health and Human Services said it would wind down nearly $500 million in mRNA vaccine development, cancelling 22 federal projects overseen by the Biomedical Advanced Research and Development Authority (BARDA), a government-backed funding body.

Last June, a Centers for Disease Control and Prevention ⁠panel backed by Kennedy voted to remove mercury-based preservative thimerosal from flu shots, despite long-standing clinical evidence of its safety.

British drugmaker GSK markets Shingrix, a vaccine for shingles, a painful viral infection that causes blisters and rashes, while Pfizer and Moderna are the leading makers of COVID-19 vaccines.

The New York Times first reported the move.