FDA Suppresses Internal Studies Showing COVID and Shingles Vaccines Are Safe as HHS Appeals Ruling That Blocked Kennedy's Schedule Cuts

The Food and Drug Administration has blocked the publication of multiple internal studies finding that COVID-19 and shingles vaccines are safe and effective, according to documents obtained by reporters this month, even as the Department of Health and Human Services appeals a March court order that halted Secretary Robert F. Kennedy Jr.'s sweeping overhaul of the nation's childhood vaccine policy.

The withheld research, which was conducted by FDA scientists in the Center for Biologics Evaluation and Research, examined real-world data on millions of vaccine doses and concluded that the immunizations carried risks far smaller than the diseases they prevent. Senior agency officials, several of whom were appointed after Kennedy took office, declined to clear the manuscripts for journal submission, telling authors the work had "messaging concerns" and would need to be paired with additional studies of adverse events, according to internal correspondence reviewed by reporters. Several of the affected scientists have since left the agency.

The move comes as HHS pursues an aggressive appeal of U.S. District Judge Sara Ellis's March 16 ruling, which sided with the American Academy of Pediatrics and a coalition of medical groups and concluded that federal regulators had acted unlawfully when they rewrote the charter of the CDC's Advisory Committee on Immunization Practices to direct it to investigate "cumulative effects" of childhood shots and ingredients like aluminum. The judge ordered the previous ACIP framework restored, but HHS notified the Seventh Circuit on April 29 it would appeal, and Kennedy's chief of staff has continued to brief outside groups that the secretary believes the courts will ultimately defer to him on scientific policymaking.

The most immediate impact has been on the routine childhood vaccine schedule, which the CDC quietly trimmed from 17 recommended immunizations to 11 last fall, eliminating routine recommendations for rotavirus, hepatitis A and certain influenza shots in young children. Pediatricians say the cuts have already produced confusion in clinics and inconsistency among insurers, several of whom have begun denying coverage for shots no longer formally recommended by the federal government. "We are seeing parents who want their kids vaccinated being told that suddenly the doses aren't covered, or that they have to argue with their pharmacist," said Dr. Susan Kressly, president of the American Academy of Pediatrics.

The friction has spilled into Congress. Senate HELP Committee Chair Bernie Sanders has subpoenaed records from the FDA and CDC related to the withheld vaccine studies and has scheduled a contentious hearing for next week at which Kennedy is expected to appear. Republicans on the committee, led by Sen. Bill Cassidy, R-La., a physician who agonized publicly over his vote to confirm Kennedy, have signaled they will press the secretary on whether internal scientific findings are being suppressed for political reasons. "If career FDA scientists found these vaccines work, the public deserves to see the data," Cassidy said in a statement.

The legal and political battles arrive against a worsening epidemiological backdrop. U.S. measles cases for 2026 have already surpassed 1,890, the highest annual figure in decades, and the CDC has warned that the country is on track to lose its measles elimination status this fall. An American medical missionary working in the Democratic Republic of the Congo tested positive for Ebola last week and was airlifted to Germany for treatment, and outbreaks of pertussis, mumps and chickenpox have ticked higher in several Mountain West states with falling MMR coverage. Public-health veterans say the pattern is exactly what they warned about a year ago when Kennedy began signaling skepticism of mainstream vaccine science.