Gennova’s mRNA vaccine to come in powder form

• Follow

The Covid-19 vaccine HGCO19, based on the mRNA technology platform, by Gennova Biopharmaceuticals, is going to be freeze-drying based or lyophilized vaccine, according to a report in Business Standard. The technology will help in the preservation of vaccines even at higher temperatures. The majority of mRNA vaccines require stringent sub-zero temperatures to maintain a stable cold chain. The vaccine will be in powder form and before the administration, it will be mixed with diluents. The Central Drugs Standards Control Organisation (CDSCO) has given approval to the company to conduct phase 2 and 3 clinical trials for its lyophilized mRNA vaccine for injection — HGCO19. Pfizer also expects its Phase 3 trial results on the lyophilized vaccine by the end of the current week.

What is freeze drying?

Freeze-drying is a process that helps the vaccines stabilise. It is a complex process. While manufacturing the liquid product undergoes freezing, primary drying, and then secondary drying to remove the solvent.

The website of Pfizer mentions that the lyophilized formulation is a single-dose product which is prepared by filling a vaccine solution into a vial, then lyophilizing or freeze-drying the contents of the vial to a powder.

In powder form, the vaccine is more stable than in liquid form. The lyophilized formulation is designed to be able to be shipped and stored at 2-8°C. The powder is reconstituted by dissolving with diluents before vaccination.

Gennova’s mRNA remains stable at 2-8°C. India at present can handle temperature integrity of 2-8°C across the cold chain.

mRNA vaccines typically have stringent temperature requirements to remain stable; the Pfizer-BioNTech vaccine needs -70°C, while Moderna vaccine can remain stable for six months at -20°C.