Gennova's mRNA vaccine
GS Paper- 2 (Diseases)
Gennova Biopharmaceuticals’ Covid-19 jab HGCO19, based on the mRNA technology platform, will be a lyophilized vaccine or one that is based on freeze-drying. This should help store the vaccine at much higher temperatures than the stringent sub-zero temperatures required to maintain a stable cold chain for other mRNA vaccines globally.
- The lyophilized vaccine will come in a powder form and it will be mixed with diluents before administration.
- In fact, Pfizer and BioNTech have already started a phase-3 study to evaluate the lyophilized (freeze-dried) formulation of the Pfizer-BioNTech vaccine.
- Gennova has got permission for the phase-2 and 3 clinical trials for its lyophilized mRNA vaccine for injection — HGCO19 — from the subject expert committee advising the Central Drugs Standards Control Organisation (CDSCO).
- Meanwhile, its peer Pfizer expects results from the phase-3 trials using a lyophilized vaccine later this year.
- Lyophilisation or freeze-drying is a complex process that is often used to stabilise vaccines.
- During the process, solvent is removed from the liquid product in manufacturing steps which include freezing, primary drying, and then secondary drying.
- The lyophilized formulation is a single-dose product prepared by filling vaccine solution into a vial, then lyophilizing or freeze-drying the contents of the vial to a powder.
- The vaccine is more stable in a powder form than liquid, and the lyophilized formulation is designed to be able to be shipped and stored at 2-8 °C.
- Prior to vaccination, the powder is reconstituted by dissolving with diluents.