"FDA officials did not allow agency scientists to submit two abstracts for studies on Shingrix, a shingles vaccine, to a major drug safety conference. The studies reportedly bolstered known efficacy and safety data of the vaccines."
"HHS spokesperson Andrew Nixon said in a statement that the axed COVID studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data."
"Nixon emphasized 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."
"Of the shingles study looking at efficacy, he said, 'The design of that study fell outside the agency's purview.' Nixon did not address why the Shingrix safety study was withheld."
FDA officials did not permit agency scientists to submit two abstracts on Shingrix, a shingles vaccine, to a major drug safety conference. These studies reportedly supported existing efficacy and safety data. HHS spokesperson Andrew Nixon stated that the COVID studies were withdrawn due to unsupported broad conclusions. He emphasized that the FDA aims to protect the integrity of its scientific process. Nixon mentioned that the design of the shingles efficacy study was outside the agency's purview but did not explain the withholding of the safety study.
Read at Ars Technica
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