Investigational Zika vaccine receives Fast Track designation
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
The US Food and Drug Administration (FDA) has granted Fast Track designation for an investigational Zika vaccine (mRNA-1893) currently being evaluated in a Phase I study for the prevention of Zika virus infection in healthy adults.
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.
Programmes with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.
“Protecting against Zika virus transmission, particularly in women during pregnancy, continues to be an area of high unmet need. 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,” said Tal Zaks, MD, PhD, Chief Medical Officer at Moderna, which manufactures the vaccine. “Our Zika program is part of Moderna’s broader commitment to improving global public health through developing mRNA vaccines to prevent the spread of infectious diseases.”
Programmes with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application
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.
Pre-clinical data published in The Journal of Infectious Diseases have shown that vaccination with mRNA-1893 protected against the transmission of the Zika virus during pregnancy in mice. mRNA-1893 is currently in a Phase I study evaluating safety, pharmacokinetics and pharmacodynamics in healthy volunteers.