Human dosing begins for first US coronavirus vaccine
pharmafile | March 17, 2020 | News story | Manufacturing and Production, Research and Development | Moderna, Vaccine, coronavirus, pharma
The race to develop a vaccine against the ongoing outbreak of novel coronavirus has stepped up with the news that biotech firm Moderna has dosed its first patient in clinical trials of its own mRNA vaccine.
The candidate, known as mRNA-1273, was developed by Moderna in partnership with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), which is sponsoring the current clinical trial.
It is to be evaluated in three dosages: 25, 100, 250 μg, delivered in two doses 28 days apart. In total, 45 healthy participants will; be administered with the vaccine in order to test its safety and efficacy, with a follow-up of 12 months.
“This study is the first step in the clinical development of an mRNA vaccine against SARS-CoV-2, and we expect it to provide important information about safety and immunogenicity. We are actively preparing for a potential Phase 2 study under our own IND,” remarked Dr Tal Zaks, Chief Medical Officer at Moderna. “We are grateful to NIH for their ongoing collaboration and to CEPI for funding the initial manufacturing of mRNA-1273 and are proud to be included with the many companies, worldwide health agencies and NGOs working on a possible response to the novel coronavirus outbreak.”
Moderna confirmed it is “actively preparing” a larger Phase 2 trial of the vaccine, and plans to work with the FDA and other government and non-government organisations to this end.
Matt Fellows
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