Vaccine Makers Keep Safety Details Quiet, Alarming Scientists

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'And greater transparency could also help bolster faltering public confidence in vaccines ... ' vaccines immunization covid19

While the broad outlines of the vaccine trial designs have been made available — including on ahas said the company could apply to the F.D.A. for emergency authorization

Company executives have provided some trial details when they have spoken on discussion panels or at investor conferences, or in news releases. But researchers looking for clues have had to comb through transcripts, videos and articles posted online, rather than to examine documents that the companies provided.

A federal clinical trial registry details the number of trial participants, who should be included and excluded from the study, and the main outcomes. But it only skims the surface, Dr. Krumholz said. “The protocols are much more detailed.” Other independent scientists said they were eager to examine the trials’ statistical analysis plans, which would guide them in analyzing the results.

“There’s no downside” to sharing the documents, said Dr. Paul A. Offit, a professor at the University of Pennsylvania who serves on the F.D.A. advisory committee that will review coronavirus vaccines. “People are skittish about these vaccines. I think it helps to be transparent.”

 

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