TUESDAY, July 14, 2020 (HealthDay News) — A leading COVID-19 vaccine contender has passed its early safety trial with flying colors.
The vaccine, created by Moderna, produced an immune response in all 45 healthy participants who received two shots 28 days apart, according to findings reported July 14 in the New England Journal of Medicine.
The vaccine (named mRNA-1273 for now) uses messenger RNA, or mRNA, to trigger an immune response to the COVID-19 coronavirus in patients.
Genetically derived from the virus, the mRNA vaccine essentially mimics a natural COVID-19 infection, tricking the body into producing antibodies that hopefully will protect against future infections.
More than half of the people given the vaccine developed some side effects, including fatigue, chills, headache and muscle pain. However, only people given the highest dose reported severe adverse effects, and no major safety concerns were identified.
“The results are promising but obviously need further confirmation and elaboration in later-stage clinical trials,” said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security in Baltimore. “There is a lot of interest in the ability of mRNA vaccines to be the quickest route to a vaccine for emerging pathogens and hopefully this aspiration will be borne out with this vaccine.”
Moderna announced last week that it had completed enrollment for phase 2 clinical trials of mRNA-1273, including 300 healthy adults aged 18 to 55, along with 300 adults aged 56 and older.
This next phase is designed to tell doctors more about how well it works, as well as continuing to gather evidence on its safety. Participants will randomly receive either a low dose of the vaccine, a high dose or a placebo, and researchers will track the progress of all three groups.
The United States has agreed to provide up to $483 million to Moderna as part of Operation Warp Speed, a federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible. The U.S. National Institutes of Health is funding the mRNA-1273 clinical trials.
More information
The U.S. Centers for Disease Control and Prevention has more about COVID-19.
SOURCES: Amesh Adalja, M.D., senior scholar, Johns Hopkins Center for Health Security, Baltimore; New England Journal of Medicine, July 14, 2020
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