As Moderna moves forward with its mRNA vaccine candidate for COVID-19, the U.S. federal government is helping accelerate the potential medication with a $483 million infusion from the Biomedical Advanced Research and Development Authority (BARDA).
The funds, announced Thursday, are expected to accelerate the development of mRNA-1273, an mRNA vaccine candidate against the disease caused by the novel coronavirus. In March, Moderna dosed the first subject with the experimental vaccine as part of its Phase I clinical trial. The trial has enrolled 45 healthy volunteers. Moderna’s mRNA-1273 is an mRNA vaccine that encodes for a prefusion stabilized form of the Spike (S) protein.
There are more than 70 vaccine candidates in development, according to a recent report from the World Health Organization. Among those include a handful that have already entered clinical trials, including Moderna’s candidate. The most advanced in terms of clinical testing is CanSino’s Phase II trial assessing its Adenovirus Type 5 Vector, Ad5-nCoV.
Under terms of the agreement with BARDA, a division of the Department of Health and Human Services, the cash is expected to fund the advancement of mRNA-1273 to FDA licensure. If the Phase I portion of the study goes well, Moderna is already planning a Phase II in the second quarter of 2020 and a Phase III could begin as early as fall, the company said. BARDA funding will support these late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response, Moderna said.
To support the anticipated scale-up, Moderna plans to hire up to 150 new employees, including an increase in its manufacturing staff. This is expected to expand manufacturing capacity from two shifts per day, five days per week to three shifts per day, seven days per week. Additional hires will include engineers to manage process scale-up, and clinical and regulatory staff to support clinical development, Moderna said.
Stéphane Bancel, Moderna’s chief executive officer, thanked BARDA for the financial support to accelerate the development of the vaccine candidate. With more than 2 million people infected with the disease, including 671,425 in the United States, Bancel said time is of the essence to develop and provide a vaccine against the pandemic.
“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,” Bancel said in a statement.
Rick Bright, director of BARDA, said a vaccine is a critical tool for stopping the spread of COVID-19. Having a vaccine available as quickly as possible is one step in helping society return to a greater sense of normalcy.
“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,” Bright said.