BARDA Gives $483M to Moderna for COVID-19 Vaccine Development

Moderna recently received $483 million from the Biomedical Advanced Research and Development Authority (BARDA) to bolster COVID-19 vaccine development using the company’s mRNA vaccine candidate.

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 The biotechnology company pioneers in messenger RNA therapeutics and vaccines to create medicines for patients. Under the terms of agreement, BARDA, a division of the Office of the Assistance Secretary for Preparedness and Response (ASPR) within HHS, will fund the advancement of mRNA-1273 to FDA licensure. 

A Phase 1 open-label study began on March 16, 2020 and NIH just recently expanded the trial to include 60 adults over the age of 56. Some will be tested in Seattle, some in Atlanta at some at the NIH in Bethesda, Maryland. 

A Phase 3 clinical trial could begin in fall 2020, but this decision is subject to data from the previous two studies.

“We are thankful for BARDA’s support to fund the accelerated development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said 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 funding will support the late-stage clinical development programs and boost mRNA-1273 manufacturing in 2020. 

Moderna will hire nearly 150 new team members in the US this year to accelerate the scale-up. This includes a boost in its skilled manufacturing staff to expand capacity from two shifts per day, five days per week to three shifts per day, seven days per week.

Additionally, engineers will manage process scale-up and clinical and regulatory staff to support clinical development.

“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” said Rick Bright, PhD, BARDA Director. “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.”

Moderna has been involved in COVID-19 pandemic fight since the beginning. At the end of January, the company joined the Coalition for Epidemic Preparedness Innovations and Inovio Pharmaceuticals to launch three programs to develop vaccines for coronavirus.

Moderna manufactured an mRNA vaccine for COVID-19 with CEPI’s funding as part of the terms of the new partnership. The biotech firm collaborated with the Vaccine Research Center of the NIH’s NIAID on the mRNA vaccine.

Initiating the three programs on January 23 set the coronavirus vaccine development efforts in motion to accelerate potential vaccine candidates into clinical testing. 

Moderna’s technology platform allows its pursuit of a robust pipeline of new vaccine candidates to respond to public health threats. It demonstrated previous positive Phase 1 data readouts for six prophylactic vaccines and its investigational Zika vaccine, which has already gone through a Phase 1 study, and was granted FDA Fast Track designation in November 2019.