Biotech Values

[DewDiligence]

Re: MRNA /unblinding and placebo crossover

MRNA’s CEO said on today’s CC that it has not yet been decided whether the phase-3 trial will be unblinded if it hits the efficacy threshold in an interim analysis, which would permit the placebo-arm patients to receive the vaccine. He further said that he expects this decision will probably not be made until the interim analysis is actually performed and all parties—MRNA, BARDA, NIAID, and the FDA—weigh in on the pros and cons.

I find it astonishing that this wrinkle has not been ironed out in advance.

p.s. PFE/BNTX’s phase-3 trial (#msg-157190178), unlike MRNA’s trial, has many ex-US trial sites; hence, the unblinding/placebo-crossover decision in that trial will presumably involve ex-US as well as US organizations.