Gaithersburg-based Emergent Biosolutions on Wednesday said it signed a second agreement in a week that will bring manufacturing of a coronavirus vaccine candidate to Baltimore.
The new agreement is with Vaxart, a San Francisco-based biotechnology company that is developing an experimental oral vaccine candidate that would be administered by tablet.
Emergent Biosolutions will use contract development and manufacturing services to move the treatment toward trials in human patients. The development services will begin immediately at its Gaithersburg location.
Manufacturing of drug substance will take place at Emergent’s facility in Baltimore’s Bayview. Emergent said that it will be able to produce material that can enable Vaxart to start Phase 1 clinical trials — which are an initial study conducted in humans to determine effectiveness and efficacy — by the second half of 2020.
In January, Vaxart started a program to apply its vaccine platform, called VAAST, to a vaccine for coronavirus.
“We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the roll-out of a large vaccination campaign, and Emergent is a great partner to help in this endeavor,” Vaxart CEO Wouter Latour said in a statement.
Efforts to develop a vaccine for coronavirus have accelerated since COVID-19 emerged in Wuhan, China, earlier this year and caused a global pandemic that has led countries including the U.S. to enact unprecedented social distancing measures that shutter schools and businesses. The genetic sequence for the novel coronavirus was shared by Chinese scientists, leading companies to respond to the public health crisis.
Health officials have said development of a vaccine is moving quickly, and the first clinical trial for a vaccine from NIH and Massachusetts-based Moderna began this week. But officials have said development of a treatment that is usable remains 12 to 18 months away. Per regulations, multiple phases of trials are required before a vaccine is approved for use by the U.S. Food and Drug Administration, and officials have warned that putting a vaccine out too quickly risks the danger of infecting more people.
Emergent is bringing its expertise in development and manufacturing of new treatments to the effort. Last week the company signed a separate agreement with Novavax to develop and manufacture a vaccine candidate after the fellow Gaithersburg biotech company received $4 million in new funding.
The Bayview facility, which was doubled in size in 2017, is one of three centers that the U.S. Department of Health and Human Services has designated as a Center for Innovation in Advanced Development and Manufacturing that can be put into action during a public health threats. The company said the center has capacity to develop “tens to hundreds of millions of doses” of a vaccine annually.-30-