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FDA approves coronavirus vaccine candidate to begin phase 2 trial

The Moderna COVID-19 vaccine candidate is one of many under development, but it was the first to begin phase one testing in March.

WASHINGTON — The U.S. Food and Drug Administration has given Moderna approval to start phase 2 trials for its experimental coronavirus vaccine.

The company announced Thursday that it's planning to have 600 participants in the phase 2 study, which it expects to begin "shortly." It's also finalizing the protocol for phase 3, "which is expected to begin in the early summer of 2020." 

Moderna's CEO, Stephane Bancel, described the start of phase 2 trials as "a crucial step forward."

The Moderna vaccine is one of many under development but was the first to begin phase one testing back in March. The first phase included 45 young, healthy volunteers. The goal was to learn about the vaccine’s safety and see how the immune system responds to it. 

The potential vaccine was developed by researchers at Moderna and the National Institutes of Health. Bancel recently told CNBC that they hope to be able to manufacture about 1 billion doses of the vaccine per year, once its approved, through a new partnership with Swiss drugmaker Lonza. 

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Dr. Anthony Fauci, the U.S. government's top expert, has cautioned that even if everything goes perfectly, 12 to 18 months to develop a vaccine would set a speed record. January will mark a year since the National Institutes of Health began creating its COVID-19 vaccine with Moderna. 

Policymakers are devising plans to try to overcome obstacles in an attempt to compress the years it usually takes to develop a vaccine. Asked if a vaccine by January was possible, Dr. Deborah Birx, the White House coronavirus task force coordinator, told Fox News Sunday “on paper, it’s possible. It’s whether we can execute,” she said.

In the U.S., the Trump administration is planning a project dubbed Operation Warp Speed that will overlap studies of “different candidates that are made differently and act differently,” Dr. Birx said.

If early evidence was strong enough and the virus is still widespread, the Food and Drug Administration might even consider emergency use of a vaccine before final test results were in, Dr. Peter Marks, who directs the FDA office that oversees vaccines, recently told reporters.

The Associated Press contributed to this report. 

Credit: AP
Pharmacist Michael Witte, left, gives Rebecca Sirull, right, a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull is the third patient to receive the shot in the study. (AP Photo/Ted S. Warren)

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