The FDA Has Approved a Coronavirus Vaccine for Phase Two Trial

Moderna’s is one of many vaccines against the coronavirus in development. Photo: Douglas Magno/AFP via Getty Images

The Food and Drug Administration has given Moderna the green light to enter into phase two of trials with its vaccine against the novel coronavirus that causes COVID-19, in what the Boston biotech firm called a “crucial step forward.”

Phase two will include 600 patients and is planned to begin “shortly,” the company said in a press release Thursday. It is also gearing up for phase three, “which is expected to begin in the early summer of 2020.” That puts Moderna on target to make the vaccine available “as soon as 2021,” it said. But manufacturing would begin sooner. Last week, Moderna’s CEO told CNBC that that firm would start building its stockpile of the vaccine as soon as July.

Moderna’s coronavirus vaccine is one of many in development, but it was the first to begin phase one of testing in March. The trial was funded National Institutes of Health and took place Seattle, one of the early U.S. hot spots of the outbreak. The trail included 45 healthy adults between 18 and 55.

Since the start of trial, the vaccine from a company that has never brought a product to market has made an impression on some important people, including Dr. Anthony Fauci, who told National Geographic that early results from Moderna are “impressive” and said the company’s success gives him hope that people will be able to get vaccinated against the coronavirus by early 2021. Others have warned that talk of such an aggressive timeline is irresponsible.

FDA Approves Coronavirus Vaccine for Phase Two Trial