Although Congress remains stalled on funding to combat the Zika virus, the Biomedical Advanced Research and Development Authority (BARDA) has taken steps to accelerate US preparedness and response efforts by awarding $8 million in funding to Moderna Therapeutics, a clinical stage biotechnology company, to develop a novel Zika vaccine.
BARDA is a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services (HHS). Under the agreement, BARDA will support a Phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing.
HHS said the agreement could be extended to include an additional $125 million in funding to support final testing and large scale manufacturing.
“BARDA is taking a three-pronged approach to combat Zika, developing vaccines, diagnostics, and technologies that will protect the blood supply. Today’s agreement with Moderna expands and diversifies our portfolio of candidate vaccines and improves our chances of having a vaccine to provide protection to people and halt the spread of the Zika virus,” said Dr. Richard Hatchett, acting director of BARDA.
Moderna’s vaccine uses messenger RNA (mRNA) vaccine technology.Messenger RNA are delivered to the body’s cells proteins, which then produce antigenic proteins as if the body was infected by avirus. The immune system remembers the proteins, which allows the body to recognize and destroy the pathogen in the future.
The company said it has already carried out preclinical work for the Zika mRNA vaccine through a grant from the Defense Advanced Research Projects Agency.
“We believe our mRNA vaccine technology offers potential advantages in efficacy, speed of development, and production scalability and reliability, which may position Moderna as a leader in preparing for and responding to infectious disease threats, such as Zika, that place millions of people at risk around the world,” said Stéphane Bancel, CEO of Moderna. “We feel a tremendous sense of responsibility to advance our Zika mRNA vaccine as quickly as possible, and we are thankful to BARDA for its commitment to support and help expedite our development efforts. We plan to initiate a Phase 1 study within the next several months.”
Moderna has two additional Phase 1 mRNA infectious disease vaccine studies currently underway in the United States and Europe and has dosed approximately 250 healthy human volunteers to date. Moderna expects to publish clinical data on its first Phase 1 study in 2017.
“With two mRNA infectious disease vaccines already advancing through clinical studies and a growing pipeline of vaccines, all based on the same underlying mRNA vaccine technology, we’re in the fortunate position of being able to rapidly apply learnings to inform our Zika vaccine development program,” said Michael Watson, President of Valera. “It’s clear the world needs novel, innovative approaches to address both known and future infectious disease threats. We hope to be at the forefront of advancing this innovation.”