Moderna, Inc has received US FDA Fast Track designation for its investigational Zika vaccine based on its messenger RNA (mRNA) technology.
The US Food and Drug Administration (FDA) has been granted to mRNA-1893, a vaccine intended to treat Zika currently in Phase I clinical studies.
The Fast Track designation is designed to speed up development and review of therapies and vaccines needed to fill an unmet medical need.
“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,” chief medical officer Tal Zaks said in a statement.
mRNA vaccines offer several advantages over traditional vaccines, Moderna explained to Bioprocess Insider.
One of these is the ability to mimic many aspects of natural viral infections. “mRNA enters cells and is used to produce viral antigen proteins from within the cell that include natural, post-translational modifications. This mimics the process by which natural viral infections occur, where information from viral genomes is used to produce viral proteins from within a cell. This can potentially enhance the immune response, including improved B and T cell responses.”
Furthermore, such vaccines utilize the multiplexing of mRNA to produce more compelling product profiles.
“Multiple mRNAs encoding for multiple viral proteins can be included in a single vaccine, permitting production of complex multimeric antigens that are much more difficult to achieve with traditional technologies,” the firm said.
“As an example, our CMV vaccine (mRNA-1647) contains six mRNAs, five of which encode five different proteins that combine to form a pentameric protein complex that is a potentially critical antigen for immune protection against CMV.”
Another advantage is the capital efficiency and speed from shared manufacturing processes and infrastructure, the firm told us.
“Traditional vaccines require product-dedicated production processes, facilities, and operators. Our mRNA vaccines are produced in a manufacturing process that is sufficiently consistent across our pipeline to allow us to use a single facility to produce all of our mRNA vaccines.”
As such, the firm opened a 200,000 square foot manufacturing facility in Norwood, Massachusetts in July 2018, to support development and production of mRNA therapies.
“The new site also houses the company’s Personalized Cancer Vaccine (PCV) Unit for individualized supply batches of mRNA for potential personalized cancer vaccines,” said Moderna.
“By making this direct investment in PCV next-generation manufacturing, the company can reduce the time it takes to manufacture a dedicated cancer vaccine for individual patients in clinical trials. The Norwood site enables the Company to leverage the potential of our mRNA platform, control our supply chain, and provide the necessary scale and flexibility to support the development of high-quality mRNA medicines.”
Related news: Moderna begins making mRNA cancer vaccine from MA plant