A Coronavirus vaccine from Moderna (NASDAQ: MRNA) just got fast-tracked by the FDA. That means the vaccine will proceed through the approval process more quickly than normal. The vaccine is starting Phase 2 clinical trials!
This the very first vaccine candidate entered human trials! The vaccine has made it there in record time. Instead of years, in 60 days!
The Vaccine candidate is the first to pass successfully the Phase 1 trials, which test the safety of the vaccine in humans. Scientists proved that there’s no virus replicating in the body, which means that the vaccine is safe!
Moderna Therapeutics, (NASDAQ: MRNA) based in Cambridge, Mass., received fast-track approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate, mRNA-1273. The FDA gave the company the green light to proceed to Phase 2 testing of the vaccine. The company plans to launch the final stage (Phase 3) this summer, as soon as the Phase 2 studies are completed, says Dr. Stephen Hoge, president of Moderna. It’s validation comes from the U.S government which FDA believes this is a very credible exercise,” says Hoge.
The Phase 2 studies include around 600 volunteers, half of whom are 18-55 years old and other half are over 55 years old. They will be assigned to receive one of two doses of Moderna’s vaccine, with doses administered 28 days apart. If all goes to plan, Moderna will continue to build out additional manufacturing sites that could bring Moderna’s capacity to 1 billion shots per year, the drugmakers said.
Moderna’s vaccine relies on a relatively new technology based on the mRNA of the virus; it involves injecting fragments of the viral genetic material into the body, which then stimulates the body’s immune system to fight the virus.
It’s full speed ahead on a COVID-19 vaccine at the highest levels of U.S. government. After press reports and Senate testimony described a “Manhattan Project” for novel coronavirus vaccines, President Donald Trump officially unveiled the program and its leaders late on Friday.
At a Rose Garden event, Trump named former GlaxoSmithKline vaccine head Moncef Slaoui and four-star general Gustave Perna to lead the charge, which aims to deliver a COVID-19 vaccine by the end of the year.
Already, based on early data for one undisclosed program, Slaoui said he’s confident the group can deliver. The GSK vet now serves on the board of Moderna, whose mRNA vaccine candidate is in human testing against COVID-19.
The “Warp Speed” group will incorporate expertise from the U.S. Department of Health and Human Services, the Department of Defense and more, FDA chief Stephen Hahn said at a Senate hearing this week.
Aside from Moderna’s vaccine, programs from Pfizer, AstraZeneca, Sanofi, Johnson & Johnson and many other companies are racing ahead. Even as researchers advance the programs through development, teams are also working to scale up massive manufacturing systems to deliver billions of doses quickly.