A coronavirus vaccine from Cambridge-based biotech company Moderna triggers an immune response, according to data published Tuesday in the New England Journal of Medicine.
The data is an analysis of the Phase 1 study of mRNA-1273, Moderna’s vaccine against COVID-19, the disease caused by the new coronavirus.
The vaccine was well tolerated by the participants, according to a press release, and created a “robust” immune response.
“These Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response at all dose levels and clearly supports the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study. “said Tal Zaks, the medical director of Moderna. “We hope to begin our Phase 3 study of mRNA-1273 this month to demonstrate the ability of our vaccine to significantly reduce the risk of COVID-19 disease.”
The vaccine was administered 28 days apart at three dose levels in 45 healthy adult participants aged 18 to 55 years. Results were reported through day 57, with no serious side effects. The data indicates that the vaccine “induced rapid and strong immune responses” against the virus, according to the press release.
The study was led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
“This positive Phase 1 data is encouraging and represents an important step forward in the clinical development of mRNA-1273, our candidate for the COVID-19 vaccine, and we thank the NIH for their continued collaboration. The Moderna team continues to focus on starting our Phase 3 study this month and, if successful, presenting a BLA, “said Stéphane Bancel, CEO of Moderna.” We are committed to advancing the clinical development of mRNA-1273 from the As quickly and safely as possible as we invest to expand manufacturing so that we can help address this global health emergency. “
According to the press release, in the cases where the vaccine had side effects, most of the participants felt fatigue, chills, headache and myalgia, all of which were transient and of mild or moderate intensity. Some participants also reported pain at the injection site.
Phase 2 of the study is a placebo-controlled dose confirmation study evaluating the safety, reactogenicity, and immunogenicity of two mRNA-1273 vaccines administered 28 days apart, according to the press release.
For Phase 3, which has been reviewed by the United States Food and Drug Administration, a 1: 1 randomized, placebo-controlled trial is planned to include approximately 30,000 participants.
The positive news about the vaccine comes when the southern and western states are seeing large numbers of new cases of coronavirus. In Massachusetts, new cases have remained lower than the increase in cases seen in April and early May.
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