FDA Suppressed Studies Affirming Safety of Vaccines

The federal government has been shelving—not spotlighting—its own positive vaccine research, the New York Times reports. The Department of Health and Human Services confirms that Food and Drug Administration officials recently blocked publication of multiple agency-run studies that largely affirmed the safety of COVID-19 and shingles vaccines, despite the projects costing taxpayers millions and reviewing records from millions of patients. Two COVID safety papers, already accepted by medical journals, were pulled in October; in February, FDA leaders declined to let staff submit Shingrix data to a major drug-safety conference. An HHS spokesman says the COVID studies were yanked because their "broad conclusions" went beyond the data and that one shingles study fell outside the FDA's remit.

Critics, including outside drug-safety experts and a Harvard professor who calls the moves "censorship," argue the work met accepted scientific standards and should have been published. The unpublished analyses found serious side effects to be extremely rare and reiterated that the benefits of vaccination outweighed risks. The decisions come as Health Secretary Robert F. Kennedy Jr.'s team has questioned other safety assurances and promoted unvetted claims about vaccine harms, deepening concern among scientists who say withholding large-scale safety data undermines, rather than protects, public trust. The Trump administration has taken several other actions making vaccines harder to access, CNBC reports. Both HHS and the FDA have been criticized for those and other moves since Trump took office, the Guardian reports.