The Pfizer Inc. PFE and BioNTech SE – ADR BNTX combo has flagged an October timeline for the release of the first two interim events from its Phase 2/3 study of the coronavirus vaccine candidate BNT162b2.
An analyst at SVB Leerink said a push backward to November shouldn't matter, and here's why.
The BioNTech Analyst: Daina Graybosch reiterated a Market Perform rating on BioNTech and raised the price target from $62 to $69.
The BioNTech Thesis: If Pfizer and BioNTech do not release the first interim readout by October, it likely means the independent, external data monitoring committee decided to continue the study through the first two interim analyses, Graybosch said in a Wednesday note.
Most investors are expecting an early positive result in October, the analyst said. They have not factored in stopping with efficacy at the upper bound of expectations coming with interim analysis or DMC decisions later than October, she said.
The BNT162b2 trial continuing to November without an announcement does not mean the vaccine efficacy will fall short of high expectations, Graybosch said.
First, the number of events for the first two interim analyses is small enough that shifting epidemiology of infection could delay the readouts, the analyst said.
Second, even if the vaccine is quite effective at preventing symptomatic diseases with, for example, 70% efficacy, the probability of the trial showing this result — thereby statistically meeting a positive stopping boundary — is low to moderate, she said.
The DMC is not bound to stop the study, even if the positive stopping rules have been met, as the protocol makes clear that efficacy and futility boundaries will be applied in a nonbinding way, Graybosch said.
"We are increasingly confident that BNT162b2 will prove efficacious in its primary endpoint of preventing symptomatic disease, given alignment of murine, non-human primate, immunogenicity (neutralizing antibodies [Nabs] and CD8+ T cell), and efficacy from antibody therapies."
Although building public skepticism will likely dampen the uptake of COVID-19 vaccines, SVB Leerink said it has increasing confidence in an annual re-vaccination market and the competitive position of BNT162b2.
BNTX, PFE Price Action: At last check, BioNTech shares were down 2.02% to $91.12. Pfizer shares were trading down slightly at $36.88.
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