In addition, the Times learned that FDA officials did not allow agency scientists to present two abstracts for studies on Shingrix, a shingles vaccine, to a major drug safety conference. The studies are said to reinforce the known efficacy and safety data of the vaccines.
HHS spokesman Andrew Nixon said in a statement that the COVID-19 studies “were retracted because the authors drew broad conclusions that were not supported by the underlying data. FDA acted to protect the integrity of its scientific process and to ensure that any work involving the agency meets high standards.”
Of the shingles study looking at effectiveness, he said, “The design of this study was beyond the agency’s purview.” Nixon did not say why the Shingrix safety investigation was stopped.
