As of Wednesday, the company had enrolled about 84% of the total participants for the Phase 3 COVE study on its vaccine candidate, mRNA-1273, across 100 research sites. An estimated 28% of these participants are from diverse communities, said a company update.
According to a report by The Boston Globe, Bancel said Moderna hoped to see results by October but a recent dip in the average national cases created difficulty in hitting the amount of infections among trial participants needed in order to see whether the vaccine candidate outperforms the placebo.
If the infection rate continues to drop, Bancel said the readout could happen in December, the outlet wrote.
Meanwhile, Albert Bourla, Pfizer CEO, said there is a “good chance” Pfizer will know safety and efficacy results by late October, The Boston Globe wrote, citing comments made Sunday on CBS’ “Face the Nation.”
Bancel reportedly said “it doesn’t matter” if Pfizer announces its efficacy results first, adding that one drug company cannot supply enough vaccines to stop the global pandemic.
Moderna published the protocol online for its late-stage trial on Thursday, which consists of a 135-page document. According to the New York Times, scientists have called for sharing of protocols so other experts can assess them.
Meanwhile, the Food and Drug Administration has previously said it expects that a “COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.”
If Moderna reaches this benchmark, Bancel reportedly said it would quickly seek emergency approval to start distribution.
“At that time, we can ship whatever we have in the warehouse” to the federal government, Bancel said, according to The Boston Globe.