The US's first COVID-19 experimental drug is on course to start a major study this coming July to prove whether it can really fight against the disease, its manufacturer disclosed on Thursday - a much-awaited step in the race for finding an effective treatment.
The drug, developed by the US National Institutes of Health and Moderna Inc., will have 30,000 volunteers to be screened and tested with the vaccine - some administered with the real shot and some a placebo.
Moderna was the first biotech firm in the US to initiate human clinical trials of its drug candidate, and the objective of the study will be to demonstrate conclusive clinical evidence that its vaccine effectively prevents people from developing COVID-19 and, second, that it prevents the materialization of at least serious symptoms and cases requiring hospitalization.
Moderna previously made public some of its "positive" interim data from Phase One drug candidate testing, saying that eight patients developed antibodies neutralizing at levels equal to those recovered from COVID-19.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the results very promising, while experts expect further data being released. Phase Two research on the vaccine is continuing.
The US government has consistently backed the shot of Moderna with an investment of $438 million from the Biomedical Advanced Research and Development Authority and accelerated status from the Food and Drug Administration, along with its initiative to push for the production of the COVID-19 vaccine.
But it is not the only firm to get support from the government. US officials took 'many shots on target' approach, as the plan was emphasized last month by Dr. Fauci. Shares for Moderna rallied more than three percent to $60.7 early Wednesday.
Moderna launched their vaccine trials with an initial 45 volunteers in middle of March. In its second stage of testing, the company said it had finished enrolling 300 younger adults and started studying how older adults react to the vaccine.
These initial studies check for side effects and how well the immune systems of people respond to varying doses. But only the immense trial still to come can show if the vaccine works.
The speed of production of a variety of leading candidates for the vaccine is in fact going just as quickly, if not faster. Johnson & Johnson said earlier this week that trials of their vaccine will begin later in July, while AstraZeneca and its research and development partner University of Oxford would start their own clinical trials this month.
There are currently no approved vaccines or treatment for the virus in the US. A COVID-19 drug is considered as essential to containing the virus that has sickened over 7.2 million people and claimed the lives of more than 412,000 around the world, while crippling economies globally.
