With a significant increase in the rate of cases across its trial sites over the last week, Moderna says its first interim analysis will have ‘substantially more’ than the 53 cases required. It is now sending the data on these cases to the independent Data Safety Monitoring Board for analysis (Moderna remains blinded as to whether cases are in the vaccine or placebo group).
The US giant has not indicated when its interim analysis will be released.
Moderna embarked on its Phase 3 COVE study of its mRNA-1273 vaccine candidate in July. On October 22, it reached full enrolment of 30,000 participants aged 18+ in the US.
The randomized, 1:1 placebo-controlled Phase 3 trial is studying mRNA-1273 at the 100 µg dose. The primary endpoint is 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.
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center.
Moderna plans to produce around 20 million doses of mRNA-1273 in 2020; rising to a figure of up to one billion doses worldwide in 2021.
Pfizer made headlines earlier this week with its COVID-19 vaccine candidate - also a mRNA vaccine - with the release of its first Phase 3 interim analysis, reporting 90% efficacy. This analysis, carried out on November 8, was based on the evaluation of 94 cases.
Moderna has completed enrolment of 30,000 people for its US Phase 3 trial. This figure includes:
- more than 7,000 people over 65 years old;
- 5,000 people under the age of 65 but with high-risk chronic diseases that put them at increased risk of severe COVID-19 (for example, diabetes, severe obesity and cardiac disease)
- 11,000 participants from communities of color (ie, 37% of the study population and similar to the diversity of the US): including 6,000 Hispanic/LatinX; and 3,000 Black/African American.