Biostatistics Division Director, Jeffrey Morris, was interviewed for this article in New York Times reporting that the FDA blocked publication of a few post-licensure safety monitoring studies.
Two of the studies were on COVID-19 boosters, one of them tracking >4 million vaccinated individuals <65yrs through insurance billing records, and the other >7.5 million vaccinated individuals >65yrs through Medicare records. Both used a self-controlled case series, which uses each subject as their own internal control to overcome between-subject confounding such as from “healthy vaccinee effect”, and each study assessed over a dozen prespecified adverse events of special interest to find if they were increased risk after vaccination.
An HHS official reported “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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.”
Morris was quoted as saying these were exactly the type of large, population level post-licensure safety monitoring studies that everyone should be interested in, and in fact if anything are not done enough, and they used standard reasonable design and analysis plans or these questions, so argued there is no valid reason to suppress publication of these studies.
In his interview, he also highlighted various strengths and weaknesses of the respective studies, suggesting revisions to improve the study and make its conclusions more precise, but these details were not included in the article.