Moderna's vaccine will begin final stage of human trials
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The US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its COVID-19 vaccine on July 27, after it showed promising results in a safety trial, researchers reported in the New England Journal of Medicine.
The trial results showed that it was safe and provoked immune responses in the healthy volunteers.
Moderna will start a late stage clinical trial for its Covid 19 vaccine candidate later this month.
The experimental vaccine will be tested in 30 states and Washington, D.C.
The study found that the volunteers who got two doses of the vaccine had high levels of virus-killing antibodies. “After the first vaccination, antibody responses were higher with higher doses. After the second dose the titers increased,” the researchers said in NEJM.
No study volunteers experienced a serious side effect, but more than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches or pain at the injection site.
Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16.
“These findings support further development of this vaccine,” it further said.
The results released Tuesday involved 45 enrolled participants. They received their first dose on March 16 and April 14. Three participants did not receive the second vaccination. “No serious adverse events were noted and no prespecified trial halting rules were met. After the first vaccination, systemic adverse events were reported by 5 participants,” it added.
The researchers found that none of the participants had fever after the first vaccination.
The Phase 3 trial will recruit 30,000 participants in the US, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.
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