India could have its first homegrown variant-specific Covid vaccine against Omicron in the next couple of months. Developed by Pune based Gennova Biopharmaceuticals using the messenger or mRNA-technology platform, the laboratory-generated vaccine to combat the fast spreading Omicron variant will be tested for efficacy and immuno genicity soon. Gennova received the required regulatory permission to develop the variant specific vaccine recently, and has already started manufacturing it for humant rials.
The company has, meanwhile, also submitted Phase 2 trial data for over 3,000 subjects pertaining to its two-dose mRNA vaccine against the Delta variant. It is close to completing Phase 3 trials and has started manufacturing the vaccine “at risk” so that vials can be rolled out in sufficient quantities if and when the formulation 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.
Dr VK Paul, chief of the national Covid-19 task force, said 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 underdevelopment 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.
Evidence from global studies suggests a mix-and-match combination - for example, using a viral vector or non mRNA vaccine, and an mRNA vaccine - produces good levels of antibodies against Covid in comparison to using the same vaccine. At present, the government has allowed the same vaccine as the first two doses for the precaution dose. It awaits real-world local data
to assess whether mix-and match vaccines could elicit a better immune response.