An investigational messenger RNA (mRNA) vaccine to prevent Zika virus infection has been granted Fast Track designation by the Food and Drug Administration.
The mRNA-1893 vaccine (Moderna, Inc.) contains an mRNA sequence encoding for the structural proteins of Zika virus. It is designed to cause cells to secrete virus-like particles, mimicking the response of the cell after natural infection.
The novel vaccine is currently being studied in a randomized, placebo-controlled phase 1 trial in healthy flavivirus seropositive and seronegative adults 18 to 49 years old. The primary outcomes of the study include frequency and grade of adverse events; geometric mean titers of neutralizing antibodies against Zika virus are being measured as a secondary outcome. A preclinical trial in mice found that vaccination with mRNA-1893 protected against congenital Zika virus transmission.
“Protecting against Zika virus transmission, particularly in women during pregnancy, continues to be an area of high unmet need,” said Tal Zaks, MD, PhD, chief medical officer at Moderna. “Fast Track designation supports our belief in the clinical potential of mRNA-1893 and the importance of developing an effective vaccine that can be rapidly developed and deployed.”
The designation allows the Company to benefit from early and frequent communication with the FDA and rolling submission of the market application.
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