Data Byte: criteria for COVID-19 vaccines to succeed in pivotal trials

At least three COVID-19 vaccine developers have publicly released the protocols of their pivotal trials. The documents lay out when interim and final analyses can occur and the criteria for meeting the primary endpoint at each milestone.

On Sept. 17, Moderna Inc. (NASDAQ:MRNA), which has mRNA-1273 in Phase III testing, became the first to reveal its complete trial protocol. Pfizer Inc. (NYSE:PFE) and partner  BioNTech SE (NASDAQ:BNTX), then AstraZeneca plc (LSE:AZN; NYSE:AZN), quickly followed suit, releasing protocols for Phase II/III candidate BNT162b2 and Phase III vaccine AZD1222, respectively (see “Moderna, Pfizer-BioNTech publish complete trial protocols”)...