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Moderna medical chief: Varying infection rate to be the biggest challenge in Phase 3

Moderna Inc is set to begin the Phase 3 clinical trials for its COVID-19 candidate mRNA–1273 on July 27

A diverse population with varying infection rates will be among the biggest challenges during the phase 3 trials of its COVID-19 vaccine prototype, mRNA-1273, Moderna Inc (NASDAQ: MRNA) Chief Medical Officer Tal Zaks said during a conference call with analysts on Wednesday.  

“In the US, we should be able to vaccinate people, some of whom ultimately, by chance and disposition, are going to be at risk and will end up being exposed to the virus. To the degree that we are unable to capture those individuals that we end up vaccinating people who do not get exposed, I think it’ll be very hard to make a determination,” he said.

The Cambridge, Massachusetts-based firm had announced earlier that it aims to kick-start the Phase 3 clinical trials for mRNA–1273 by July 27. Notably, this is one of the most advanced COVID-19 vaccine prototypes that are under development across the globe.

Phase 3 COVE study

Christened COVE, the Phase 3 study will have prevention of symptomatic COVID-19 disease as the primary endpoint and prevention of severe disease and infection from the virus as secondary endpoints.

During the conference call with analysts, Zaks said that old people would account for a significant portion of the trial patients as they are more vulnerable to the pandemic.

“That’s how we can ensure that we’re not just bringing effective vaccines to those who are more likely to get infected but also making sure that we understand the safety and efficacy in those who are more likely to get sick,he said.

On the successful completion of the trials, Moderna hopes to deliver 500 million to a billion doses of the drug a year, beginning 2021 through its US manufacturing facility, as well as through Swiss multinational biotechnology firm Lonza Group. Separately, Moderna has announced partnerships with New Jersey-headquartered Catalent and Madrid-based Laboratorios Farmaceuticos ROVI for the large-scale, commercial fill-finish manufacturing of the vaccine.

The company expects the initial deployment to be handled in collaboration with the government.

Phase 1 interim analysis shows no serious adverse events

Moderna was among the first companies to venture into COVID vaccine research. Phase 1 trials were kick-started in April, followed by mid-scale Phase 2 trials in May.  The company’s CEO Stéphane Bance had stated that he is “80-90% sure” that the drug, which works well against pathogens causing MERS, Zika and CMV, would come out successful against 2019-nCoV coronavirus.

On Tuesday, the company published the interim analysis from the Phase 1 study of mRNA-1273, which is basically an RNA sequence that deploys antibodies that fight the infection, in The New England Journal of Medicine. The study, led by the National Institute of Allergy and Infectious Diseases (NIAID) showed no serious adverse events at the end of the observation period of 57 days. The study was evaluated across three dosage levels in 45 adults of age group 18-55.  

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Windfall in the market

Moderna shares soared over 18% immediately following the announcement. It is one of the best-performing stocks this year, quadrupling in value since January 1.  The company is also set to become a component of the prestigious NASDAQ-100 index, starting Monday, July 20.

INOVIO Pharmaceuticals (NASDAQ: INO), Novavax’s (NASDAQ: NVAX) and Johnson & Johnson’s (NYSE: JNJ) are some of the other key US companies that are developing a vaccine for COVID-19.  

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