Moderna, which has partnered with the National Institute of Allergy and Infectious Diseases in the trials, is pushing forward with a larger phase 2 study. The alternative is simply to give test subjects doses of the vaccine and see who ends up COVID-positive in the normal course of their lives - a process which is less controversial but requires much more time.
"I think 25 [micrograms] gets us there but you always want to have somewhat of a margin", Tal Zaks, Moderna's chief medical officer, tells STAT. Thus, he said, "the degree of confidence within the company was always high" that it would succeed this time, too.
Moderna's stock price was up 40 per cent in pre-market trading as the results emerged.
Vials of the company's mRNA-1273 vaccine were shipped to HHS in February, and the vaccine was tested on humans in March. At a medium dose, of 100 micrograms, he said, the vaccine candidate created "more antibodies" than those created naturally by recovered patients.
The vaccine was "generally safe" and well-tolerated, the company said, adding that its phase two trials will be updated to study two dose levels of 50 and 100 micrograms. The new coronavirus, known as SARS-CoV-2, has infected more than 4.7 million people and killed over 300,000, spurring a global race by drugmakers, academic institutions and governments to find a vaccine. Since all of the current vaccines that are used in humans use all or most of the target virus to train the immune system, the RNA vaccine is, in theory, faster to mass-produce.
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The CMO further stated that they were hopeful that the low dose would be the one that would work best, "The lower the dose, the more vaccine we'll be able to make", he revealed. The primary goal for that first phase was to determine if the vaccine was safe.
All of the volunteers made antibodies in response to the vaccine, and when those antibodies were tested in human cells in the lab, they stopped SARS-CoV-2 from replicating, which means they neutralized the virus. This particular vaccine is developmentally backed by the United States government and Phase 1 trialing was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The U.S. Food and Drug Administration (FDA) has given the biotech firm a green light to begin their second phase of trials which entails trying out their experimental vaccine on at least 600 volunteers. We think this strongly supports the idea that Moderna's vaccine is capable of protecting individuals against the virus, although we have yet to see data showing whether this efficacy is also seen in older adults, and long-term safety data will continue to be collected (for one to two years in a phase 3 trial).
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.
Moderna recently announced a partnership with the giant drugmaker Lonza to boost its manufacturing capacity to up to one billion doses a year. And it's a bit early to say with certainty that these antibodies will protect the study's participants against the coronavirus.