The Pune firm recently submitted Phase 2 trial data of over 3,000 subjects of their two-dose mRNA vaccine developed on the delta variant, and is close to completing Phase 3 trials, sources told TOI. It has started manufacturing the vaccine “at risk” and can roll out “sufficient” quantities once it gets the regulatory nod. India’s drug regulator is expected to review the data this week and take a decision regarding the approval soon, official sources said.
Pune-based Gennova has developed the mRNA vaccine for the Omicron variant in the laboratory, which will be tested for human use for efficacy and immunogenicity soon, sources told TOI.
Dr VK Paul, chief of the national Covid-19 task force, told TOI that the development of the mRNA platform was a significant scientific feat for the country. The thermo-stable vaccine (using the existing cold chain infrastructure) and the platform could be useful for Covid once deployed, and even beyond, he said. The Omicron-specific vaccine under development is also exciting while the quick-switch platform would come into play as and when mutant strains emerge, he said.
“The drug regulator will study and take a decision on whether an approval can be given (to Gennova),” Dr NK Arora, chairman of India’s technical advisory group on Covid vaccination, said.
Bharat Biotech recently claimed that a booster shot of its Covaxin would neutralise the Omicron variant, but it is understood that the data is yet to be studied by the regulator. Globally, too, Moderna, Janssen, Sinopharm, Gamaleya, Novavax and AstraZeneca are being tested to check their efficacy against Omicron, while many others are in development. Pfizer said its mRNA vaccine that targets the Omicron variant would be ready in March.
A safe and effective vaccine using the next-generation mRNA platform could be an important option for boosting the immunity of health workers and the vulnerable population, as well as to widen the vaccine basket for the country’s Covid immunisation programme.
Gennova, a subsidiary of Emcure Pharmaceuticals, is also progressing on a paediatric vaccine for the age group 5 to 17 years, and has submitted the stipulated protocol to conduct trials. The mRNA vaccine technology is synthetic in nature and has the potential to reduce the speed of vaccine development timeline, Gennova Biopharm CEO Dr Sanjay Singh told TOI. The same tech platform, so-called ‘pandemic-ready’, can be utilised and scaled up quickly as the virus mutates.