The Late Stage Clinical Development
The US-based pharmaceutical company, Moderna Inc. has recently announced that it has received an additional $472 million from the US government’s Biomedical Advanced Research and Development Authority (BARDA) to support the late-stage clinical development. The clinical development includes the expanded phase 3 study of Moderna’s COVID-19 vaccine. The phase 3 trial of the vaccine mRNA-1273 is expected to begin today. The biotechnology company said that the interim results phase-1 trial of its vaccine, induced rapid and strong immune responses against the SARS-CoV-2 virus. The company had previously received up to $483 million from BARDA to support the scale-up of its vaccine and clinical development. It will now receive about $955 million from BARDA under the terms of the revised contract.
BARDA’s continued Commitment
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine against COVID-19,” said Stephane Bancel, Moderna’s Chief Executive Officer. “Encouraged by the phase-1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks,” he further added. According to the company, phase 3 randomized, 1:1 placebo-controlled trials will include approximately 30,000 participants at the 100µg dose level in the US. The phase 3 trials will assess the safety and efficacy of the vaccine. As coronavirus pandemic continues to spread, scientists are racing against time to develop a safe vaccine using different methods. Moderna’s vaccine is created using synthetic messenger RNA (mRNA) to inoculate against the coronavirus. The company further said it remains on track to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021. Moderna is closely working with operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN), to conduct the phase 3 COVE study.