After racing into Phase I trials in just 63 days, Moderna’s vaccine looks set to become the first vaccine to enter Phase III trials, as the company announced that it would begin a trial in the US during July.
The trial will include 30,000 participants in the US, which will be conducted alongside the National Institute of Allergy and Infectious Diseases (NIAID).
In terms of the endpoints, the company stated that the primary endpoint would be the prevention of symptomatic COVID-19 disease, with secondary endpoints including the prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.
Moderna will move ahead with a 100 μg dose, with the company already having sufficient supply for the clinical trial. In Phase II trials, participants received two vaccinations with mRNA-1273, spaced 28 days apart.
With the dose level chosen, the company was able to anticipate the manufacture of approximately 500 million doses per year, with this potentially rising to one billion doses, beginning in 2021.
Moderna is working alongside Lonza to ready the production of the vaccine candidate, utilizing the latter’s facilities in the US and Europe to supplement the former’s in-house production capacity in the US.
The company’s vaccine is one of a leading pack that have been reportedly selected by the US government for further support. Other companies in this group include AstraZeneca, Johnson & Johnson, Merck, and Pfizer.
