In the US, clinical stage biotech Moderna has bagged fast track designation for its mRNA vaccine candidate (mRNA-1273) against novel coronavirus (SARS-CoV-2).
Fast track status is designed to accelerate the development and review of therapies and vaccines for serious conditions that might fulfil an unmet medical need.
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, chief medical officer at the firm.
“As we await the full set of clinical data from the NIAID-led Phase I study, we are actively preparing for our Phase II and Phase III clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
Moderna said it has already received initial feedback from the US Food and Drug Administration on the design of the planned Phase II study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
The company plans to enrol 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above, who will be assigned to receive placebo, a 50?g or a 250?g dose at both vaccinations.