It is the first announced BA.2-specific vaccine to enter animal testing, with BA.2 being a subvariant of Omicron first identified at the end of December. The company will also test the vaccine against Omicron: noting the shelf-stable advantages of the DNA vaccine against Omicron-specific mRNA vaccines also in development.
With the technology stable at room temperature for more than three months, the vaccine will be aimed at low and middle-income countries with limited access to existing options.
The company boasts a platform designed for use in medical-resource limited settings and with the ability for ‘massive scale-up’ of manufacturing and deployment using existing technologies and facilities around the world. It also claims that the platform is ‘at least as fast to develop and as programable as mRNA platform vaccines’.
Pandemic prepardness toolkit
Similar to mRNA vaccines, DNA vaccines cause an individuals cells to produce an antigen protein: DNA instructs cells to produce an antigen-coding mRNA (the same mRNA sequence leading vaccine brands are manufacturing).
Unlike mRNA vaccines, DNA vaccines are stable at room temperature, making them easier to store and transport than mRNA vaccines, particularly in parts of the world that lack the required cold-chain transport and storage infrastructure.
The technology can also be scaled rapidly in that it can use existing commodity plasmid DNA manufacturing capacity that already exists around the world.
"Because our vaccine is extremely simple - just plasmid DNA in a common buffer, the manufacturing process is much more straightforward than for mRNA or viral vector vaccines," a spokesperson for the company told us.
"In fact, plasmid manufacturing is commonly the first of many steps used to produce mRNA or other vaccines, whereas in our case it's the only step. And we estimate that there is sufficient fill/finish capacity around the world to support that part of the process.
"Room temperature storage and shipping makes it easier to get doses from manufacturers all over the world to the places that need them most. We are working with multiple manufacturing partners in different countries to make this even more convenient, and ultimately aim to have strategically placed facilities in operation around the globe."
Alvea is also working with partners and advisors to identify and address the complex technical, logistical, regulatory, and commercial issues that have slowed the distribution of other vaccines in low-income countries.
The company hopes to be in a position to file for regulatory approval early this summer.
