Candidate COVID-19 Vaccine Shows ‘Promising Results’ as it Goes Into Final Phase
Moderna, the US biotech firm currently leading the global race towards a vaccine for the Sars-CoV-2, the virus which causes the COVID-19 disease, will enter the final stage of clinical human trials.
Interim Results from Phase 1
Shortly two months after they have announced positive interim data, Moderna has announced through a press release that their vaccine candidate against the novel coronavirus 2019 (COVID-19), the mRNA-1273, will move into a bigger study after announcing the publication of interim results from their Phase 1 of their study in a peer-reviewed medical journal. Moderna is the first company to conduct the first human clinical trial for a potential COVID-19 vaccine.
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The Phase 1 of the study conducted two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 microgram, 100 microgram, or 250 microgram in an open-label trial that includes 45 healthy adults, 18 to 55 years of age. As published in The New England Journal of Medicine, the preliminary report states that the mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses were observed in 100% of evaluated participants and no trial-limiting safety concerns were identified.
According to Chief Medical Officer of Moderna Tal Zaks, M.D., Ph.D., the Phase 1 data demonstrate that vaccination with mRNA-1273 elicits a robust immune response across all dose levels and clearly support the choice of 100 µg in a prime and boost regimen as the optimal dose for the Phase 3 study.
Stéphane Bancel, Chief Executive Officer of Moderna also stated that,
“These positive Phase 1 data are encouraging and represent an important step forward in the clinical development of mRNA-1273, our vaccine candidate against COVID-19, and we thank the NIH for their ongoing collaboration. The Moderna team continues to focus on starting our Phase 3 study this month and, if successful, filing a Biologics License Application (BLA),” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are committed to advancing the clinical development of mRNA-1273 as quickly and safely as possible while investing to scale up manufacturing so that we can help address this global health emergency.
With the promising results from the earlier phases, the COVE study, which is what they will call the third phase of the study, will include approximately 30,000 participants at the 100 microgram dose level in the U.S.
Moderna has just completed manufacturing the vaccine required for Phase 3 of the study and the randomized, 1:1 placebo-controlled trial will start on July 27.
New England Journal of Medicine