First human trial for coronavirus vaccine

Biotech News: Moderna, a clinical stage biotechnology company, announced that the first adult has been dosed in the Phase I study of the company’s mRNA vaccine against the novel coronavirus (SARS-CoV-2).

The Phase I study is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 (25, 100, 250 μg) administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein.

“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,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna.

On January 11, 2020, the Chinese authorities shared the genetic sequence of the novel coronavirus. On January 13, 2020 the VRC and Moderna’s infectious disease research team finalised the sequence for the SARS-CoV-2 vaccine and Moderna mobilised toward clinical manufacture. The first clinical batch was completed on February 7, 2020 and underwent analytical testing; it was shipped on February 24, 2020 from Moderna and delivered to NIH from the Company’s manufacturing facility in 42 days from sequence selection.

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Next Steps for mRNA-1273

The Company is actively preparing for a potential Phase II study under its own IND to build on data from the ongoing Phase I study being conducted by the NIH. In order to continue to progress this potential vaccine during the ongoing global public health emergency, Moderna intends to work with the FDA and other government and non-government organisations to be ready for a Phase II and any subsequent trials, which are anticipated to include a larger number of subjects and which will seek to generate additional safety and immunogenicity data.

Manufacture of the mRNA-1273 material for the potential Phase II trial, which could begin in a few months, is underway. Moderna continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective.

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