Efforts could boost the country’s pharmaceutical industry and ease global distribution
Genova’s candidate, known as HGCO19, is funded by the government and is being developed in conjunction with Seattle-based HDT Bio Corp. The key feature of the vaccine, Chief Executive Sanjay Singh said, is that it can be stored between 2 degrees Celsius. and 8 °C (35.6 °C to 46.4 °F), making it more manageable for easy distribution in low- and middle-income countries where storage and logistics can be a challenge. The mRNA vaccines developed by Moderna and Pfizer with BioNTech SE of Germany are to be stored at supercooled temperatures.
Developing a new vaccine could be a significant step forward for India’s pharmaceutical industry, which has large production capacity and grew largely from UK-based AstraZeneca plc’s manufacturing of drugs developed elsewhere, including a version of the COVID-19 vaccine Is.
VK Paul, who leads the health team at the National Institution for Transforming India, said, “India is setting up a significant vaccine capacity using mRNA technology platforms not only for COVID-19 vaccines, but also for pre-existing and emergent ones. tries.” A government think tank that has helped lead India’s vaccination campaign.
Unlike conventional vaccines, which use a live virus to trigger an immune response in humans, those made using the messenger ribonucleic acid, mRNA, carry genetic instructions that develop antibodies against infection. Spike proteins.
Gennova’s HGCO19 is designed to be simpler to manufacture than existing mRNA shots. Using a process called freeze-drying or lyophilization, the company will make the vaccine in powder form, making it more stable and easier to ship, in addition to being stored at moderate temperatures. The powder may be reconstituted by dissolving it with a diluent prior to vaccination.
Pfizer and BioNTech have also started a study To evaluate a lyophilized formulation for their COVID-19 vaccine, and the results are expected later this year, according to information on the company’s website.
Another distinguishing feature is that GenOVA candidates use self-amplifying mRNA instead of non-replicating mRNA. It helps to give smaller doses while having the same effect, minimizing side effects, Mr. Singh said.
The Indian drug regulator last month approved Genova’s vaccine candidate for Phase II and III trials after the shot was found to be safe and effective in an early-stage study.
The company began Phase 2 testing this month and is expected to launch Phase III by mid-October at sites across the country. Around 4,400 volunteers will be enrolled in both the phases.
Genova President Satish Mehta said the company aims to get HGCO19 approved for emergency use by Indian authorities this year and to manufacture 60 million doses by the end of December, mostly for distribution in the government immunization programme.
Genova has begun preparations to expand production capacity to become an important part of its India’s vaccination campaign for adults and children, and as a booster for other vaccines in India and in other emerging markets.
The company is also hoping to play a role in supplying the vaccines through the World Health Organization and sharing technology to make the vaccine elsewhere. WHO chief scientist Soumya Swaminathan last week visited Genova’s facility in the western Indian city of Pune to discuss the vaccine.
Some manufacturers, notably the French healthcare company Sanofi Per,
mRNAs are holding back the development of COVID-19 vaccines, given that the market is already crowded. WHO, however, wants to expand the capacity of low- and middle-income countries to produce COVID-19 vaccines, some of which will be distributed through the Covax facility.
Ms Swaminathan said Genova’s mRNA-based vaccine candidate “looks very promising in terms of immunogenicity and safety in its Phase 1 trial, although more results from Phase 2 and 3 trials are awaited.”
Shahid Jameel, one of India’s top virologists and visiting professor at Ashoka University, said, “This is a completely new platform for India and should be seen as an investment in the future.”
India has so far authorized emergency use for two locally developed COVID-19 vaccines made by Bharat Biotech International Ltd and Zydus Cadila..
Serum Institute of India is also collaborating with UK’s AstraZeneca to develop the vaccine, while Russian vaccine Sputnik V is being produced in small quantities by some Indian manufacturers.
India’s drug regulator allowed emergency use for Moderna’s vaccine in June, but the government has yet to guarantee compensation against prosecution in case of an adverse reaction, slowing its rollout.
A senior government official said that Pfizer also planned to supply an initial 50 million doses to the Indian government this year, but with the locally manufactured vaccine stock increasing, Indian policymakers are trying to provide the legal framework for this to happen. I am progressing slowly.
A Pfizer spokesperson in India said the company is working with Indian government officials to make the vaccine available for use in the country.