The Food and Drug Administration (FDA) has granted Fast Track designation to the vaccine candidate, mRNA-1273 (Moderna), against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
mRNA-1273 is a novel lipid nanoparticle-encapsulated mRNA vaccine that encodes for a prefusion stabilized form of the spike (S) protein of SARS-CoV-2. According to NIH scientists, the vaccine is expected to “direct the body’s cells to express the spike in its prefusion conformation to elicit an immune response.”
Moderna is expected to begin a phase 2 study of mRNA-1273 following the recently completed review of it’s Investigational New Drug (IND) application by the Food and Drug Administration (FDA). The study, which intends to enroll 600 healthy patients, will evaluate the safety, reactogenicity and immunogenicity of mRNA-1273 administered on a 2-dose vaccination schedule, given 28 days apart.
Additionally, a protocol for a phase 3 study is being finalized with the expectation that the trial could potentially begin in early summer 2020. The Company is also awaiting results from its ongoing National Institute of Allergy and Infectious Diseases (NIADH)-led phase 1 study of mRNA-1273.
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, MD, PhD, Chief Medical Officer at Moderna. “As we await the full set of clinical data from the NIAID-led phase 1 study, we are actively preparing for our phase 2 and phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
For more information visit modernatx.com.