U.S. biotech company Moderna on Monday announced positive interim clinical data of mRNA-1273, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
The results came from Phase 1 study, led by the National Institute of Allergy and Infectious Diseases, which began in Seattle in March.
Moderna has vaccinated dozens of study participants and measured antibodies in eight of them.
All eight developed neutralizing antibodies to the virus at levels reaching or exceeding the levels seen in people who have naturally recovered from COVID-19, according to the company.
The vaccine mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies, said the company.
These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 mcg, said Tal Zaks, chief medical officer at Moderna.
“When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials,” Zaks said.
The Moderna team continues to focus on moving as fast as safely possible to start the pivotal Phase 3 study in July, said Moderna CEO Stephane Bancel. “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”