Moderna has finalised the protocol for the Phase III clinical trial of its Covid-19 vaccine candidate, mRNA-1273, based on feedback from the US Food and Drug Administration (FDA).
The trial is set to be performed in partnership with the US National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID). It will enrol about 30,000 participants in the US.
The primary endpoint of the Phase III trial is the prevention of symptomatic Covid-19 disease while key secondary endpoints include the prevention of severe Covid-19 and SARS-CoV-2 infection.
The primary efficacy analysis will depend on the number of participants having symptomatic Covid-19.
Based on the Phase I trial data, the 100μg dose was selected as the optimal dose level to maximise the immune response and minimise adverse reactions.
The company has finished the production of vaccine doses required to begin the Phase III trial. It is expected that Phase III dosing will commence next month.
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As 100μg is selected as the Phase III trial dose, Moderna expects to be able to deliver about 500 million vaccine doses each year and possibly up to one billion doses annually, starting next year.
Moderna chief medical officer Tal Zaks said: “We look forward to beginning our Phase III study of mRNA-1273 with some 30,000 participants in July.
“Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of Covid-19 disease.”
Vaccine candidate mRNA-127 is currently in a Phase II clinical trial, which will enrol 600 healthy participants aged 18 and above.
Moderna noted that enrolment for the first cohort, consisting of adults aged 18-54, is fully complete. Participants will be followed up to 12 months following the second vaccination.