Monday, March 16, 2020

First U.S. clinical human trial of potential coronavirus vaccine set to start Monday

A human clinical trial of a potential vaccine for the new coronavirus will begin on Monday, the AP reports. The trial, which will test the effects of an experimental vaccine shot developed by the National Institutes of Health and drugmaker Moderna, won’t make use of either an active or inactive sample of the virus, as is common for vaccines, but will instead use a gene-based method that uses messenger RNA to trigger an immune response in the target individual.

The Wall Street Journal reported on the vaccine being developed by Moderna in February, which is a relatively young company built around this gene-based approached to drug therapy development. At the time, the paper reported that testing was set to begin in April, but it seems like the change in the situation globally between the end of February and today have accelerated the timelines involved. That said, any final validation of a vaccine, even if it proves effective in trials, is at least a year to 18 months out according to public health officials.

This effort by Moderna and NIH is hardly the only attempt at a vaccine in development to address the continued threat posed by COVID-19; many efforts by both public and private sector participants, on both vaccines and cures, are in process. But this one is fast-tracking the human trial aspect of the clinical testing program.

Because its participants aren’t actually receiving the virus through the injection, they’re not at risk for contracting COVID-19 through the testing program. But there are still a lot of unknowns when it comes to injecting any newly-developed drugs, even into otherwise young and healthy volunteer participants like the reported 45 individuals taking part in this program. At this stage, NIH and Moderna will be looking to ensure that the drug being developed doesn’t produce any unwanted or dangerous side effects, after which further tests will be needed to prove efficacy and other elements of safety.



from TechCrunch https://ift.tt/39U32yL

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