“The mRNA platform is disease-agnostic. We had started work on this a few years back when we collaborated with Seattle-based HDT Biotech Corporation for developing a therapeutic vaccine for cancer (human papillomavirus-induced cervical cancer in women),” said Samit Mehta, president and chief operating officer, Gennova. He added that the company planned to use the platform to make vaccines for the Zika virus, shingles, and TB.
“Vaccines and even medicines used to fight TB are not new. New research is the need of the hour and several government organisations are keen to use the mRNA technology (tech) to develop a TB vaccine. We feel there can be a multivalent approach taken to develop a TB vaccine candidate,” he said.
On the Covid-19 vaccine front, the company will submit the clinical trial protocol for Phase 2 and 3 studies to the drug regulator for approval. If things go as planned, the trials should end by the end of this year and the vaccine could be available in the market. The firm, which started with importing finished products (erythopoietin) and marketing them, has now developed several biologics product development platforms. It is also looking at developing monoclonal antibodies.
The health ministry had noted that it expected 60 million doses of Gennova’s mRNA Covid vaccine between August to December. While the Pune-based firm did not wish to offer a timeline, it indicated it is working towards meeting the commitment.
The mRNA vaccine candidate contains a short, synthetic version encoding the spike protein (antigen) of the novel coronavirus Sars-CoV-2. This interacts with the receptors of host cells. When the vaccine is injected into the body, the synthetic mRNA is taken to the muscle cells, where it instructs the cells to make numerous copies of the mRNA and copies of the antigen. This primes the body's immune system, which learns to identify the coronavirus and protect the body when attacked by the actual virus.
mRNA vaccines typically have stringent temperature requirements to remain stable. The Pfizer-BioNTech vaccine needs minus 70 degrees Celsius, while the Moderna vaccine can remain stable for six months at minus 20 degrees Celsius. However, Gennova has developed the vaccine to be stable at 2-8 degrees Celsius, making logistics easier.
Once launched, Gennova expects its vaccine to find takers – for one, it would be easier to maintain temperature integrity, and two, there would be a need for booster shots.
Satish Mehta, promoter and chief executive officer (CEO) of Emcure Group, said if latest research is any indication, there will be a need for booster doses of the Covid vaccines. “The best available vaccine will have demand,” he said.
He, however, also pointed out that manufacturing of the vaccine requires almost 43 different raw materials. The supply chain for the mRNA vaccine raw material is yet to evolve. “Some areas may need backward integration,” he added.
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