The additional BARDA funding will support the expanded Phase 3 study of Moderna’s potential Covid-19 vaccine candidate mRNA-1273
Moderna, a clinical-stage biotechnology firm, has expanded its contract with the Biomedical Advanced Research and Development Authority (BARDA) to receive additional funding of up to $472m.
The new funding is expected to support the late-stage clinical development, including the expanded Phase 3 study of the company’s potential Covid-19 vaccine candidate mRNA-1273.
mRNA-1273 is an mRNA-based vaccine candidate that works against the Covid-19 encoding for a prefusion stabilised form of the spike (S) protein, selected by the company in partnership with investigators from the NIH’s Vaccine Research Centre (VRC).
Moderna chief executive officer Stéphane Bancel said: “We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against Covid-19. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the Covid-19 pandemic and preventing future outbreaks.”
Moderna has received a total of approximately $955m funding from BARDA
Moderna has initially secured a $483m grant from the BARDA to support the clinical development of mRNA-1273, with a limited number of participants in Phase 3 clinical trial.
After talks with the US Food and Drug Administration (FDA) and Operation Warp Speed (OWS), Moderna has planned for a larger Phase 3 clinical trial, which requires additional funding. The company has revised its funding contract with BARDA to address the additional requirement.
Under the terms of the revised agreement, BARDA will support the late-stage clinical development of mRNA-1273, including the execution of US Phase 3 study, enrolling 30,000 participants. The total value of BARDA funding reaches approximately $955m.
Moderna said that its planned Phase 3 study protocol has been reviewed by the US Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for Covid-19 vaccine studies.
Prevention of symptomatic Covid-19 disease is the primary endpoint, while prevention of severe Covid-19 disease and prevention of infection by SARS-CoV-2 include the important secondary endpoints of Phase 3 clinical trial.
The company is said to be on track to deliver around 500 million doses per annum and is aiming at producing up to 1 billion doses per annum of its potential Covid-19 vaccine from its US manufacturing site, in collaboration with Lonza.
Furthermore, Moderna has recently joined forces with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at the latter’s biologics facility in Indiana.