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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.

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.