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.

What

  1. The lyophilized vaccine will come in a powder form and it will be mixed with diluents before administration.
  2. In fact, Pfizer and BioNTech have already started a phase-3 study to evaluate the lyophilized (freeze-dried) formulation of the Pfizer-BioNTech vaccine.
  3. 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).
  4. Meanwhile, its peer Pfizer expects results from the phase-3 trials using a lyophilized vaccine later this year.
  5. Lyophilisation or freeze-drying is a complex process that is often used to stabilise vaccines.
  6. During the process, solvent is removed from the liquid product in manufacturing steps which include freezing, primary drying, and then secondary drying.
  7. 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.
  8. 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.
  9. Prior to vaccination, the powder is reconstituted by dissolving with diluents.