A late Wednesday announcement from Moderna Inc MRNA 5.34% signaled that the biopharma is still locked in a neck-to-neck race with Pfizer Inc. PFE 2.84% to develop a coronavirus vaccine.
What Happened: The number of COVID-19 cases required to conduct the pre-planned first interim analysis of Phase 3 data has accrued, the Cambridge, Massachusetts-based company said.
The Phase 3 COVE study is a large-scale, multicenter study of Moderna's investigational vaccine candidate RNA-1273.
The 30,000-strong study is evaluating a 100 mcg dose of the vaccine, with the primary endpoint being the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.
With a significant increase in the rate of case identification across the company's sites in the last week, the first interim analysis will include more than 53 cases, which Moderna said is the targeted trigger point for analysis.
The company said data on these cases is being prepared for submission to the independent Data Safety Monitoring Board for analysis and recommendation. As of now, Moderna is blinded to whether the participants received the vaccine candidate or placebo.
What's Next: Given the achievement of the criteria for interim analysis, Moderna could release the interim readout anytime in the coming days.
Stakeholders will likely make comparisons with Pfizer's data, which showed vaccine efficacy of over 90%.
Both the companies are developing a new class of mRNA vaccine against the novel coronavirus, making comparisons inevitable.
The focus is also likely to rest on safety signals.
With the increase in COVID-19 infection rates, the sell-side sees scope for more than one company to operate profitably in the market.
As for Pfizer, analysts model revenue between $4.6 billion to $7.2 billion in 2021.
https://www.benzinga.com/general/biotech/20/11/18342060/moderna-achieves-covid-19-case-number-for-first-interim-readout-whats-next
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