July 15 (UPI) – The US biotech company Moderna said a vaccine it is developing has been shown to induce a “fast and strong” immune response against COVID-19, indicating that it will begin late-stage testing in less than two weeks.
In a press release, the company said analysis of trial results for its possible COVID-19 vaccine “mRNA-1273” reaffirmed the “evaluation of positive provisional data” it announced in mid-May when the drug showed by first time a “potential to prevent” the deadly and infectious coronavirus.
During the trial, 45 healthy adult volunteers under the age of 55 received two doses of the vaccine 28 days apart, and all participants who received doses of the drug in 100 micrograms or less reported only mild and transient reactions such as fatigue, chills, and soreness. head
The results conclude that the vaccine candidate has been shown to be “generally safe and well tolerated” with no reported serious adverse effects for 57 days.
“This positive Phase 1 data is encouraging and represents an important step forward in the clinical development of mRNA-1273,” said Tal Zaks, medical director of Moderna, in a statement.
The company said it will begin the third phase of the vaccine candidate’s study on July 23 with 30,000 participants, indicating that its study protocol has been reviewed by the US Food and Drug Administration and is aligned with its guidance on clinical trial design.
The study will be a randomized, placebo-controlled trial of the drug at the 100-microgram dose level, the company said.
He added that he is also on track to administer about 500 million doses per year with the possibility of manufacturing one billion doses of the vaccine starting in 2021.
“We are committed to advancing the clinical development of mRNA-1273 as quickly and safely as possible while investing in expanding manufacturing so that we can help address this global health emergency,” said Stephane Bancel, CEO of Moderna, at a statement. .
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