Moderna's Chief Medical Officer Dr. Tal Zaks.
"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus", Zaks said. Thus, he said, "the degree of confidence within the company was always high" that it would succeed this time, too.
The stock of the company jumped 24 per cent in early trading Monday on Wall Street.
A candidate vaccine for Covid-19 developed by the drug maker Moderna appears to generate an immune response similar to the response seen in people who have been infected by the virus and recovered, the company said Monday. Each group received a different amount of the vaccine, either a 25, 100 or 250 microgram dose.
The NIAID-led study is assessing three doses of the vaccine in healthy participants ages 18-55: 25 µg and 100 µg, based on two doses as of day 43; and 250 µg, based on one dose as of day 29.
Earlier this month, President Donald Trump said he felt very confident that the US would have a vaccine to fight the new coronavirus by 2021. While this is the first research released from a human trial of a potential covid-19 vaccine, Moderna's data has yet to be independently verified and isn't complete. The data also hinted that the higher doses prompted stronger immune responses.
Moderna said the vaccine appeared to show a dose response, meaning that people who the 100 mcg dose produced more antibodies than people who got the lower dose.
This is the first COVID-19 vaccine to make it through the first round of clinical trials.
He further revealed that they had also carried out additional tests on mice and found that the vaccine could prevent the virus from replicating in their lungs and that the animals developed high levels of neutralizing antibodies.
It can typically take years of clinical trials before a vaccine is considered safe enough to market, and some scientists, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, have stated that vaccine won't be ready by the fall. Moderna is allied with the National Institutes of Health and recently partnered with Lonza to manufacture mRNA-1273. The company hopes by July to begin a Phase III study, aimed at showing that the vaccine can actually prevent disease.
Reducing the dose required to produce immunity could help spare the amount of vaccine required in each shot, meaning the company could ultimately produce more of the vaccine. Our hope for a return to social and economic normalcy hinges on the production of a safe, effective vaccine.
Now CureVac's chief operating officer and acting CEO, Franz Werner-Haas, Ph.D., is trying to turn the spotlight back on the science behind the company's mRNA vaccine candidate.
President Trump may have referred to the Moderna trial when he spoke briefly to reporters Sunday at the White House upon returning from Camp David.
Moderna recently announced a partnership with the giant drugmaker Lonza to boost its manufacturing capacity to up to one billion doses a year.
A few dozen volunteers participated in the first stage of the study, but Moderna said data were available for only a small portion of them.
Worldwide there have been over 4.7 million confirmed cases and almost 316,000 deaths.
There are now no approved treatments or vaccines for COVID-19.
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