mRNA-1893 contains an mRNA sequence encoding for the structural proteins of the Zika virus and is designed to cause cells to secrete virus-like particles, mimicking the response of the cell after natural infection.
mRNA-1893 is indicated for avoiding transmission of the Zika disease from a mother to an unborn child
August 19, 2019: Moderna Inc. announced that the Food and Drug Administration had approved its potential vaccine for the Zika virus for a fast track to approval.
- Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.
- Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.
Clinical Trial NCT04064905: Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Healthy Flavivirus Seropositive and Seronegative Adults (Recruiting)
- This clinical study will evaluate the safety, tolerability, and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive adults ages 18-49
- Primary outcome measures include frequency and grade of adverse events
- Secondary outcome measures include geometric mean titers of neutralizing antibodies against Zika virus