US biotech company Moderna on Monday announced that its early-stage trial of a possible coronavirus vaccine had shown "positive interim" results by successfully eliciting COVID-19 antibodies in its first eight participants
WASHINGTON (Pakistan Point News / Sputnik - 18th May, 2020) US biotech company Moderna on Monday announced that its early-stage trial of a possible coronavirus vaccine had shown "positive interim" results by successfully eliciting COVID-19 antibodies in its first eight participants.
"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 (micrograms)," Dr. Tal Zaks, chief medical officer at Moderna, said in a company statement. "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."
During the trial, the experimental vaccine mRNA-1273 was administered to 45 participants with either a 25, 100 or 250 microgram dose, the company said.
The positive findings come from the first four participants in the groups who received either 25 microgram or 100 microgram dose levels beginning in March, the company said. The test elicited neutralizing antibodies in all eight of these individuals, the company said. Antibody data is not yet available for the other participants.
However, "mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies" for all 45 of the participants, the company said.
Based on the results of the interim Phase 1 data, the company will advance its study to Phase 2, the release added.
"With today's positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA," company's Chief Executive Officer Stephane Bancel said in the statement. "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."
Moderna anticipates starting the final stage, or Phase 3 of its trial in July 2020.
