Pfizer Inc. PFE, which is one of the five companies shortlisted by the U.S. government's Operation Warp Speed coronavirus vaccine program, reported positive preliminary data Wednesday.
The readiout is from the Phase 1/2 study of the mRNA vaccine against coronavirus that Pfizer is co-developing with German biopharma BioNTech SE – ADR BNTX.
What Happened: The preliminary data showed that at day 28, or seven days after the second dose, all subjects who received 10 micrograms or 30 micrograms of BNT162b1 had significantly elevated RBD-bindings IgG antibodies.
The vaccine candidate is the most advanced of Pfizer and BioNTech's four investigational vaccine candidates from the BNT162 RNA-based vaccine program, dubbed Project Lightspeed.
At day 28, all subjects receiving either dose had SARS-CoV-2 neutralizing antibodies, the companies said.
The results were from an ongoing Phase 1/2 placebo-controlled, observer-blinded trial that is evaluating 45 subjects in the U.S.
The companies also noted that local reactions and systemic events after immunization were dose-dependent and generally mild to moderate and transient, with no serious adverse events reported.
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What's Next: After further data is compiled from the ongoing Phase 1/2 trial of four vaccine candidates, a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study involving up to 30,000 healthy participants will be selected.
The companies expect to initiate the study as early as this month.
In the event the vaccine yields positive results in the clinics and obtains regulatory clearance, the companies expect manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.
PFE, BNTX Price Action: At last check, Pfizer shares were 4.86% to $34.28 and BioNTech was advancing 6.42% to $71.03.
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