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Saturday, December 12, 2020

J&J cuts the size of its COVID-19 vaccine trial

 

  • Johnson & Johnson (NYSE:JNJ) has cut the size of its pivotal Phase 3 clinical trial in the U.S. against COVID-19 from 60,000 to 40,000 trial participants, STAT News reported.
  • Formerly, the largest COVID-19 vaccine study, J&J's ENSEMBLE trial, will now be similar in size to the Phase 3 trial advanced by Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) and bigger than that conducted by Moderna (NASDAQ:MRNA).
  • The change in size reflects the severity of COVID-19 infection in the U.S., which allows the developers to reach conclusions based on a smaller study.
  • The only major trial experimenting with a single-dose jab against COVID-19 has already recruited 38,000 subjects, Moncef Slaoui, the head of Operation Warp Speed, said last week.
  • A statement from J&J read, “we continue to anticipate that interim data from the ENSEMBLE trial will be available by the end of January. If the vaccine is safe and effective, an emergency use authorization application could be submitted to the FDA in February.”
  • https://seekingalpha.com/news/3643900-j-and-j-cuts-size-of-covidminus-19-vaccine-trial

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