Shares of Moderna surged by more than 10% in premarket trading Thursday after it announced that the Food and Drug Administration cleared its coronavirus vaccine for phase 2 trial, what the company called a “crucial step.”
Moderna said it will begin phase 2 trials with 600 participants shortly and is finalizing plans for a phase 3 trial as early as this summer.
“We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective,” CEO Stephane Bancel said in a statement. The company hopes to start a phase 3 trial early this summer here, which would potentially approve the first batch as soon as 2021, he said.
The race to develop anything to fight the coronavirus is intensely competitive and investors are watching closely for signs of progress on treatments and vaccines. Moderna, as well as other companies in the race, is ramping up manufacturing ahead of approval so that it can rapidly distribute doses if their candidate proves effective against the virus and safe for humans.
Last week, Moderna announced a 10-year partnership with Swiss drugmaker Lonza to accelerate production of the experimental vaccine. Bancel told CNBC at the time that the company hopes to begin manufacturing its potential vaccine “as early as July.”
“Our team is ready to start dosing as soon as we get the green light,” Bancel said on “Squawk Box.”
The potential vaccine, which was developed by researchers at Moderna and the National Institutes of Health, became the first candidate to enter a phase 1 human trial in March.
The vaccine candidate uses synthetic messenger RNA to inoculate against the virus. Such treatments help the body immunize against a virus and can potentially be developed and manufactured more quickly than traditional vaccines.
Covid-19 has infected more than 3.7 million people around the world and killed at least 264,000, according to data compiled by Johns Hopkins University.
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