FDA Blocks Publication of Covid-19 and Shingles Vaccine Safety Studies

In October 2025, FDA scientists were instructed to withdraw two Covid-19 vaccine studies that had already been accepted by peer-reviewed journals. In February 2026, senior FDA officials declined to approve abstracts from a Shingrix (shingles vaccine) study for a major drug-safety conference. The agency has also halted other research affirming the safety of widely used Covid-19 and shingles vaccines.

New York Times

The withdrawn studies were produced by FDA researchers in partnership with data-analysis firms, examining millions of patient records and concluding that serious adverse events were very rare. Public funding for the projects amounted to several million dollars. Observers have described the actions as part of a broader effort to restrict public access to vaccine safety data, reduce research funding, and limit dissemination of findings that support vaccine efficacy.

New York Times

The Department of Health and Human Services, represented by spokesperson Andrew Nixon, said the withdrawals were necessary because the authors “drew broad conclusions that were not supported by the underlying data.” He added that 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 Shingrix efficacy study, Nixon noted that “the design of that study fell outside the agency’s purview.”

New York Times

Critics argue that the agency’s moves curtail transparency and impede independent verification of vaccine safety. They contend that limiting publication of peer-reviewed findings may undermine public confidence and hinder ongoing vaccine-research efforts, especially given that the blocked studies were funded with taxpayer dollars.

New York Times

• “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data. The F.D.A. acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.” — Andrew Nixon, HHS Spokesperson

New York Times

• “The design of that study fell outside the agency’s purview.” — Andrew Nixon, HHS Spokesperson

New York Times

The FDA has not set a timeline for reconsidering the withdrawn manuscripts. Advocacy groups have called for an independent review of the data, and congressional oversight committees have expressed interest in the agency’s handling of vaccine-safety research. Future publications may depend on whether the FDA revises its approval criteria and whether external pressure prompts a reassessment of the blocked work.

New York Times