It is the first specific BA.2 vaccine announced to enter animal testing, with BA.2 being a subvariant of Omicron first identified in late December. The company will also test the vaccine against Omicron: noting the long shelf-life 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 targeted at low- and middle-income countries with limited access to existing options.
The company has a platform designed for use in settings with limited medical resources and with the possibility of “massive scaling up” of manufacturing and deployment using existing technologies and facilities in the world. whole world. He also claims that the platform is “at least as fast to develop and as programmable as mRNA platform vaccines.”
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Similar to mRNA vaccines, DNA vaccines cause an individual’s cells to produce an antigenic protein: DNA instructs cells to produce mRNA coding for the antigen (the same mRNA sequence as major brands of vaccines manufacture).
Unlike mRNA vaccines, DNA vaccines are stable at room temperature, making them easier to store and transport than mRNA vaccines, especially in areas of the world that lack the transport infrastructure. and storage of the required cold chain.
The technology can also be scaled up quickly as it can utilize the existing basic plasmid DNA manufacturing capacity that already exists in the world.
“Because our vaccine is extremely simple – just plasmid DNA in a common buffer, the manufacturing process is much simpler than for mRNA or viral vector vaccines,”a company spokesperson told us.
“In fact, making plasmids is usually the first of many steps used to produce mRNA or other vaccines, whereas in our case it’s the only step. And we feel there’s a capacity sufficient filler/finisher in the world to support this part of the deal.
“Storing and shipping at room temperature makes it easier to get doses from manufacturers around the world to where they are needed most. We are working with multiple manufacturing partners in different countries to make this even more convenient, and aim to ultimately to have strategically placed facilities in operation around the world.
Alvea is also working with partners and advisors to identify and resolve complex technical, logistical, regulatory and commercial issues that have slowed the distribution of other vaccines in low-income countries.
The company hopes to be able to file for regulatory approval in early summer.