Moderna’s COVID-19 Trial Delayed: Should Investors Worry?
Moderna (NASDAQ: MRNA) was one of the first companies to kick off a phase 1 clinical trial for its investigational COVID-19 vaccine, mRNA-1273. The trial in question, led by the National Institutes of Health (NIH), started in mid-March and enrolled 45 healthy adult volunteers. The trial tested the vaccine's safety, immunogenicity (ability to cause immune system response), and reactogenicity (possible side effects). After getting the green light from the U.S. Food and Drug Administration (FDA), Moderna started a phase 2 trial for mRNA-1273 in May. This trial will test the safety, immunogenicity, and reactogenicity of the vaccine in a pool of 600 healthy participants.
On June 11, the biotech company announced that it had finalized the protocol for its phase 3 clinical trial for mRNA-1273. Moderna plans on enrolling 30,000 participants for this trial, whose primary endpoint will be "the prevention of symptomatic COVID-19 disease." Although Moderna expected to start this late-stage study this month, the start of this trial has been delayed, according to a report from STAT, a healthcare industry news website.
Moderna's shares have soared by almost 200% year to date, mainly due to its efforts to develop a vaccine for COVID-19. But what should investors make of this latest development?
Source Fool.com
