US Government’s BARDA to fund Moderna’s coronavirus vaccine by $483m

pharmafile | April 17, 2020 | News story | Medical Communications, Research and Development BARDA, COVID-19, Moderna, coronavirus, pharma 

Moderna has secured $483 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), to drive development and availability of its messenger RNA (mRNA) vaccine candidate against the novel coronavirus.

The agreement means that BARDA, a division of the US Department of Health and Human Services (HHS), will finance the development of Moderna’s candidate, known as mRNA-1273, to secure approval from the FDA with the aim of making the therapy accessible US citizens as soon as possible once its safety and efficacy can be proven.

Currently, the candidate is being trialled by the National Institutes of Health (NIH) in a Phase 1 study in 45 health participants between the ages of 18 and 55. The NIH later added cohorts for adults aged 51-70 and 71 and above, with enrolment currently in progress.

“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” remarked BARDA Director Dr Rick Bright. “Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action. BARDA’s goal is to have vaccine available as quickly as possible and preparing now for advanced stage clinical trials and production scale-up while the Phase 1 is underway could shave months off development of COVID-19 vaccines.”

Under BARDA’s funding, Moderna plans to launch Phase 2 studies in the second quarter of this year provided the candidate proves its safety profile at Phase 1. If all goes successfully, the company aims to move to Phase 3 as early as the fourth quarter of the year.  

As part of the agreement, BARDA will also help Moderna scale up its manufacturing capacity for the vaccine “to enable potential pandemic response”.

“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” commented Stéphane Bancel, Moderna’s Chief Executive Officer. “Time is of the essence to provide a vaccine against this pandemic virus. By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”

BARDA has been partnering with key companies to fund promising prophylactic therapies against the novel coronavirus, most notably with Sanofi in February to support development of the French firm’s recombinant DNA-based vaccine.

Matt Fellows

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