Moderna enters P3 trials for vaccine, with $483m BARDA push
Moderna confirmed that it had received $483m (€412m) in financial support from the US Biomedical Advanced Research and Development Authority (BARDA) to support its late-stage clinical development.
The following day, the company confirmed that its Phase III trial into its mRNA vaccine candidate, mRNA-1273, had begun, with the first participants receiving doses.
The additional funding means that Moderna has received approximately $1bn in financial support to accelerate the clinical development and manufacture of its vaccine, after it received $483m in April to support the scale up of manufacture from BARDA.
Late-stage trials
The Phase III study plans to include 30,000 participants, with the trials set to look place across 100 clinical research sites in the US.
The primary endpoints will be the prevention of symptomatic COVID-19 disease, with secondary endpoints including the prevention of severe COVID-19 and prevention of infection by SARS-CoV-2.
Moderna will collaborate with PPD to conduct the trials, with the contract research organization (CRO) also supporting the Phase II study of the vaccine candidate.
According to PPD, it is working to “reach a diverse population” in the trials to ensure that the vaccine is able to protect those at the highest risk for COVID-19.
Manufacturing
Moderna is working with Lonza in the US to ensure that it is able to produce enough vaccines for the trial and then for commercial supply.
In the announcement, Modern confirmed that it will be able to produce 500 million doses per year in 2021, with the potential to increase this to one billion doses.
In Europe, the company recently signed a deal with Laboratorios Farmacéuticos Rovi for the fill-finish of the vaccine in Europe to supply ‘hundreds of millions’ of doses for the ex-US market.
