US Biotech company Moderna announced on Tuesday (Jul 19) that a potential coronavirus vaccine it is developing has produced a “robust” immune response in all patients participating in early vaccine trials..
The results of new trial published online by the New England Journal of Medicine, showed that the vaccine induced the desired immune response for all 45 people evaluated—a larger group than in the preliminary data Moderna released in May—and was generally safe and well-tolerated.
On May 18, the company had announced that that a phase-one human trial of its experimental coronavirus vaccine produced COVID-19 antibodies in every one of its participants. The trial was jointly run by National Institute of Allergy and Infectious Diseases (NIAID) and Moderna.
“These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels,” Moderna chief medical officer Tal Zaks said. “We look forward to beginning our Phase 3 study of mRNA-1273 this month to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
“This is really quite good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview Tuesday. NIAID co-developed the Moderna vaccine and led the study.
“The gold standard of protection against a viral infection is neutralizing antibodies,” he added. “And the data from the study, small numbers as it may be, are pretty clear that this vaccine is capable of inducing quite good [levels] of neutralizing antibodies.”
Moderna is beginning its wide-ranging Phase 3 of the vaccine on July 27, enlisting 30,000 people at 90 different locations ho will take two doses of the vaccine, one at the beginning of the trial and another four weeks later.
Test sites will focus on current coronavirus hotspots as it will help generate answers about the vaccine’s efficacy sooner compared to people in places where new cases have declined.
Moderna said that the Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies.
“The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2. “ the company announcement said.
Moderna uses a proprietary mRNA platform for vaccine developemnt. mRNA relies on the body’s own cells to produce viral proteins. Once injected into the body, the RNA slips into human cells and tells them to make virus-like proteins, in this case the “spike" protein on the surface of the coronavirus. If the vaccine works, those proteins then trigger the body to generate protective antibodies.
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