Moderna has announced the start of a trial of 30,000 subjects to demonstrate that the vaccine is safe
Moderna’s COVID-19 vaccine could be implemented later this year, US officials said Monday, after the drug maker announced the start of a trial of 30,000 subjects to demonstrate that it is safe and effective, the final hurdle before of approval by global regulators.
The trial is the first such late-stage study under the Trump administration’s program to accelerate the development of measures against the new coronavirus, adding to hopes 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 to fund several vaccine candidates under its Operation Warp Speed program.
More than 150 coronavirus vaccine candidates are at various stages of development, with about two dozen prospects who have advanced to human testing.
“Having a safe and effective vaccine distributed by the end of 2020 is a difficult goal, but it is the right goal for the American people,” said director of the National Institute of Health (NIH), Francis Collins, in a statement announcing the start. of the great phase. III trial.
Manufacturers are increasing production while testing to respond as quickly as possible to the virus, which is still rapidly spreading worldwide. COVID-19 has killed more than 650,000 people worldwide and has hit economies.
Moderna could have tens of millions of doses ready when and if the vaccine is deemed safe and effective, Collins told reporters in 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, the top US infectious disease official, said a trial reading could come in November, December, or even earlier. Fauci said he was “not particularly concerned” about the safety of the vaccine after looking at data from earlier smaller trials.
The study also seeks to determine if the vaccine can prevent coronavirus-related deaths.
The test volunteers will receive two separate injections about 28 days, either 100 micrograms of mRNA-1273 or a placebo.
The results of a small early-stage study published earlier this month showed that volunteers who received two doses of the Moderna vaccine had levels of antibodies to the virus that were above the average observed in people who had recovered from COVID-19.
Moderna said it is on track to administer around 500 million doses a year, and possibly up to a billion doses a year, as of 2021.
(Except for the headline, this story has not been edited by NDTV staff and is posted from a syndicated channel.)
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