Additionally, the Times learned that FDA officials did not allow agency scientists to present two summaries of studies on Shingrix, a shingles vaccine, to a major drug safety conference. The studies reportedly reinforced known vaccine efficacy and safety data.
HHS spokesman Andrew Nixon said in a statement that the canceled COVID studies “were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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.”
Regarding the shingles study looking at effectiveness, he said, “The design of that study was outside the agency’s purview.” Nixon did not explain why the Shingrix security study was withheld.
