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Tuesday, May 19, 2020

May 19, 2020
ALEX HOGAN/STAT

THE FIRST VACCINE FOR COVID-19 to be tested in humans appears to be safe and able to stimulate an immune response against the virus.

The vaccine manufacturer, Moderna, said Monday that the findings are based on results from the first eight people who received two doses of the vaccine mRNA-1273 beginning in March.

The healthy volunteers made antibodies against COVID-19 that were then tested in human cells in a lab. The antibodies produced by the volunteers were able to stop the virus from replicating, the key to an effective vaccine.

Moderna said that the levels of antibodies matched the levels found in people who had contracted the virus in the community and recovered. The company can now soon move forward on an accelerated timeline, beginning its next phase, which includes a study of 600 people.

The company said the vaccine was "generally safe and well tolerated" with a safety profile similar to other Moderna infectious disease vaccines.

The only incidence of a grade 3 adverse event, or side effect, was redness around the injection site in one volunteer. In clinical trials, adverse events have five levels, with grade 3 classified as severe. No grade 4 or 5 incidents were observed.

Stéphane Bancel, CEO of Moderna, said in a press release that "the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July."

Moderna is investing to scale up manufacturing in order to maximize the number of vaccines it can produce "to help protect as many people as we can from SARS-CoV-2," the virus that causes COVID-19, Bancel added.

Several studies testing the efficacy and safety of potential vaccines are ongoing, but no proven vaccine or treatment against the coronavirus currently exists.

Health officials report more than 4.73 million cases of the coronavirus across the globe, with more than 315,495 deaths. The U.S. leads the world in cases, more than 1.48 million, and deaths, nearly 90,000.
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