Moderna announced yesterday that it had expanded its contract with the Biomedical Advanced Research and Development Authority (BARDA) for its mRNA-1273 COVID-19 vaccine. BARDA had earlier awarded the company up to $483 million. They added another $472 million in support of late stage development including the expanded Phase III trial, which also launched today.
After discussions with BARDA and the U.S. Food and Drug Administration (FDA), Moderna chose to run a significantly larger Phase III clinical trial of the vaccine. BARDA is expanding their support of the mRNA-1273 clinical program, including of the 30,000 participant Phase III trial in the U.S. The total grant is now $955 million.
Operation Warp Speed, the Department of Health and Human Services’ and the Department of Defense’s program to deliver 300 million doses of a COVID-19 vaccine by early 2021, has been investing heavily in promising vaccine programs. On July 22, they invested $1.95 billion in the Pfizer and BioNTech program.
Stéphane Bancel, Moderna’s chief executive officer, stated, “We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19. Encouraged by the Phase I data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
The Phase III COVE (Coronavirus Efficacy) trial launched today, in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and BARDA. It is expected to include about 30,000 participants in the U.S., evaluating 100 microgram doses of the vaccine in a randomized, placebo-controlled study. The primary endpoint will be prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19, defined as need for hospitalization, and prevention of SARS-CoV-2 infection regardless of symptoms.
In addition to working with NIAID, BARDA, and NIAID’s COVID-19 Prevention Network (CoVPN), it is collaborating with PPD, a global contract research organization. PPD already provided support for the Phase II trial, which enrolled 600 participants at eight research sites within one month. The organization also provided a range of clinical development and laboratory services, including consultation on study design, patient-enrollment epidemiology modeling and biostatistics.
Moderna and partners have chosen almost 100 clinical research sites that represent appropriate demographics, including a diverse population.
The company also indicates it is on schedule to be able to deliver about 500 million doses of the vaccine each year and potentially up to 1 billion doses per year starting in 2021. This is due to both its own U.S. manufacturing operations and a strategic collaboration with Switzerland-based Lonza. Moderna also signed a collaboration deal with Catalent for large-scale, commercial fill-finish manufacturing of the vaccine at Catalent’s biologics facility for the U.S., and with ROVI in Spain for fill-finish manufacturing outside the U.S.
“We are pleased to have started the Phase III COVE study,” Bancel said. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
Moderna’s COVID-19 vaccine, mRNA-1273, is an mRNA vaccine against SARS-CoV-2 that encodes for a prefusion stabilized form of the Spike (S) protein. The Phase III trial, typically the final stage needed for approval for use, will enroll about 30,000 participants in the U.S. They will be randomized 1:1 to receive either a placebo or the vaccine.
On Tuesday, May 18, Moderna released positive interim Phase I data from its clinical trial of mRNA-1273. The company reported overall positive results for both efficacy and safety, although not a lot of details were released on the actual data. They then published the data in The New England Journal of Medicine. The bottom line was the trial showed promising safety and immune response in all the patients involved in the trial.
The interim analysis was of a two-dose vaccination schedule given 28 days apart at three different dose levels, 25, 100 and 250 micrograms in 45 healthy adults ranging in age from 18 to 55 years. The data published was on results through Day 57.
“These Phase I data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 microgram in a prime and boost regimen as the optimal dose for the Phase III study,” said Tal Zaks, Moderna’s chief medical officer. “We look forward to beginning our Phase III study of mRNA-1273 this month to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”