Buck up campers, it might all be over soon. On Monday morning, Pfizer (PFE -3.25%) and BioNTech (BNTX -1.54%) announced success with their coronavirus vaccine candidate, BNT162b2, following the first interim analysis of a gigantic phase 3 trial.
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The independent data monitors tasked with watching the phase 3 trial had been expected to conduct the first interim analysis once 32 trial participants had tested positive for COVID-19. Once the FDA, Pfizer, and BioNTech had finished discussing the merits of waiting for a minimum of 62 cases to conduct the first interim analysis, the number of volunteers that tested positive for COVID-19 had already reached 94.
It looks like the vast majority of the first 94 positive cases occurred in the placebo group. BNT162b2 was found more than 90% effective at preventing COVID-19 infection based on the results of the first interim analysis.
Since beginning on Jul. 27, 2020, the phase 3 study has enrolled more than 43,500 participants. None of those participants know if they've been randomized to receive BNT162b2 or a placebo yet. The independent data monitors will keep all the data blinded until a total of 164 volunteers test positive for COVID-19.
To satisfy the FDA's coronavirus vaccine safety hurdles, Pfizer and BioNTech will need to wait until at least the third week of November. The agency is insisting on a median of two months of safety data following their second dose of BNT162b2.
Pfizer and BioNTech think they can produce up to 50 million doses of their vaccine candidate by the end of 2020, and up to 1.3 billion doses in 2021.
