Moderna’s COVID-19 vaccine could be deployed by the end of this year, U.S. officials said on Monday, after the drugmaker announced the start of a 30,000-subject trial to show it is safe and effective, the last hurdle before approval by global regulators.
The trial is the first such late-stage study under the Trump administration’s program to accelerate development of measures against the novel coronavirus, adding hope that an effective vaccine will help end the pandemic. Shares of Cambridge, Massachusetts-based Moderna rose 9%.
Moderna has received nearly $ 1 billion from the U.S. government, which is helping fund several vaccine candidates under its Operation Warp Speed program.
More than 150 vaccine candidates against the coronavirus are at different stages of development, with about 20 potential candidates having advanced to human testing.
“To have a safe and effective vaccine distributed by the end of 2020 is an ambitious goal, but it’s the right goal for the American people,” said Francis Collins, director of the National Institutes of Health (NIH), in a press release announcing the start of the big phase. III trial.
Manufacturers are ramping up production while testing is ongoing in order to respond as quickly as possible to the virus, which is still spreading rapidly around the world. COVID-19 has killed more than an estimated 650,000 people around the world and shattered economies.
Moderna could have tens of millions of doses ready when and if the vaccine is found to be safe and effective, Collins told reporters on a call.
The large, late-stage trial is designed to assess the safety of Moderna’s mRNA-1273 vaccine and determine whether it can prevent symptomatic COVID-19 after two doses.
Anthony Fauci, America’s top infectious disease official, said a reading of the essay could take place by November, December, or even earlier. Fauci said he was “not particularly concerned” about the safety of the vaccine after seeing smaller data from earlier trials.
The study is also looking to determine whether the vaccine can prevent coronavirus-related deaths.
Trial volunteers will receive two injections approximately 28 days apart of 100 micrograms of mRNA-1273 or placebo.
The results of a small preliminary study published earlier this month showed that volunteers who received two doses of Moderna’s vaccine had anti-virus antibody levels that were above the average seen in people who had recovered. of COVID-19.
Moderna said he remains on track to deliver around 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021.
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