The head of the US government’s Operation Warp Speed COVID-19 vaccine program, Moncef Slaoui, said he expects Phase 3 clinical trial data for several coronavirus vaccines in the period. from November to December. BNT162b2, the vaccine developed by Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) and mRNA-1273 from Modern (NASDAQ:ARNM) will be in the first round, Slaoui said at a symposium hosted by Johns Hopkins University and the University of Washington. Data on Astra Zenecait’s (NASDAQ:AZN) the vaccine from studies in the UK, Brazil and South Africa could arrive from late October to November.
That’s a slight delay from the projections the companies gave the earliest the data was available. Pfizer and BioNTech said they may have data as soon as the end of this month. And Moderna management referenced owning data around Thanksgiving. Of course, depending on when the data appears in November or December, the delay may be only a few days.
In many clinical trials, the timing of data is known because patients are treated for a period of time and then evaluated to see if the drug worked. But vaccine trials are more like cancer trials. Patients are treated, then researchers have to wait for an event: disease progression or death for cancer studies, or development of COVID-19 for coronavirus vaccine studies.
Because researchers don’t know which participants get the vaccine and which get the placebo, trials are set up to be stopped after a certain number of infections, and then researchers look at what treatment each infected person received to see if the vaccine worked. Studies have interim insights built in so data monitoring committees can stop studies if it’s clear the vaccine is working.
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