Policy & Regulation
US FDA grants Moderna's mRNA-1893 fast track designation
21 August 2019 -

The United States Food and Drug Administration (FDA) has granted fast track designation to United States-based Moderna for its investigational Zika vaccine, mRNA-1893, it was reported yesterday.

Presently, the mRNA-1893 vaccine is being evaluated in a phase one study to prevent Zika virus infection in healthy adults. The product included an mRNA sequence that encodes for the structural proteins of Zika virus. It is designed to help cells to secrete virus-like particles, helping to mimic the response of the cell after natural infection.

The phase 1 trial is evaluating the safety, pharmacokinetics and pharmacodynamics of the product in healthy volunteers. The company's randomised, observer-blind, placebo-controlled and dose-ranging study has been framed to evaluate the safety, tolerability and immunogenicity of mRNA-1893 in healthy flavivirus seropositive and seronegative adults aged between 18 and 49 years.