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Moderna completes enrolment of phase 3 COVID-19 vaccine trial

Late-stage study hits 30,000 participant target

Moderna has completed enrolment of its late-stage phase 3 COVID-19 vaccine study, with 30,000 participants now enrolled in the study.

According to the company, 25,654 participants have now received their second vaccination with Moderna’s vaccine candidate, mRNA-1273, in the phase 3 COVE study.

The biotech company also touted the diversity of its trial population, with participants from minority groups represented in the overall group. In total, 37% of the trial populations consists of participants from minority ethnic groups, representing 11,000 volunteers.

In addition, Moderna has included participants with higher risks of contracting COVID-19 or developing severe disease, with 25% of the trial population being over the age of 65 years.

On top of that, over 8,000 participants are living with chronic diseases and 22% are healthcare workers. Another 2,000 participants are retail, restaurant and hospitality workers.

Moderna’s COVID-19 vaccine entered phase 3 in record time, with the US National Institutes of Health (NIH) partnered study launching back in July.

The primary endpoint of the COVE study is the prevention of symptomatic COVID-19 disease, with key secondary endpoints including the prevention of severe COVID-19 disease and prevention of infection with SARS-CoV-2, which causes COVID-19, regardless of symptoms.

Moderna’s shot is among a number of candidates supported by funding from the US’ Operation Warp Speed initiative.

In April, the US Department of Health and Human Services (HHS) announced up to $483m available for Moderna’s vaccine candidate, with this agreement expanded on 26 July to include an additional $472m to support the late-stage clinical development.

Earlier this week, Operation Warp Speed’s chief adviser Moncef Slaoui said that Moderna and Pfizer be the first companies with COVID-19 vaccine candidates to apply for emergency use authorisation from the US Food and Drug Administration (FDA).

"It's not a certainty, but the plan - and I feel pretty confident - should make it such that by June, everybody could have been immunized in the US,” Slaoui told ABC News.

Interim analysis from a phase 1 study of mRNA-1273 published in July showed that the vaccine produced rapid and strong immune responses against SARS-CoV-2 in all participants tested.

Following two doses of the vaccine, neutralising antibody levels among vaccinated participants were similar to those seen in individuals who had previously tested positive and recovered from COVID-19.

Article by
Lucy Parsons

23rd October 2020

From: Research

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