Were everything to go to plan, India’s very own m-RNA (messenger-RNA) vaccine could be ready by March. Pune-based Gennova Biopharmaceutical’s novel m-RNA vaccine candidate was approved for funding as early as July by the Department of Biotechnology (DBT). However, being a biological product that requires genetic manipulation, it needs to be cleared by the Review Committee on Genetic Manipulation (RCGM), a DBT body, before it can approach the Drug Controller General of India (DCGI) for human trials.
Sanjay Singh, CEO, Gennova Biopharmaceuticals, said he was unperturbed. “Very soon, we will have news to share on our progress. The world needs a billion doses and encouraging as the Pfizer results are , they have only committed to 60 million doses,” he told The Hindu . He said that were everything go to plan, India could be ready with efficacy results from its own m-RNA vaccine by March.
On Monday, Pfizer-BioNTECH, announced in a news release that their m-RNA vaccine candidate had shown “90% protection” in a sample of volunteers who were part of an ongoing Phase-3 trial.
India’s regulatory agencies were treating m-RNA vaccine candidates with “caution”, said a person involved in evaluating India’s COVID-19 vaccine candidates, who declined to be named, adding, “The preclinical data has already been evaluated and it looks promising. But because the m-RNA platform is novel, there are no approved commercial vaccines of the type anywhere, there have been concerns over its stability, and there is more caution on this technology. But Pfizer’s announcement could give a significant boost [to the m-RNA platform].”
An m-RNA or simply “RNA vaccine” uses the genetic sequence of a portion of the virus that can be injected into the body. Once taken in by the body’s cells, the hope is that it makes an antigen to which the immunity machinery can manufacture antibodies. In this way, the adverse reactions that can result from the traditional approach of introducing an actual virus, or a piece of it, can be avoided. Another advantage of m-RNA vaccines is that they can be made in large quantities quicker than traditional vaccines as they don’t need to be cultured in chicken or mammalian cells.
Though Pfizer’s early results have been regarded as promising by experts, it also signals confidence in the m-RNA approach by other vaccine candidates such as Moderna, which is also being tested in people and is expected to announce results within weeks.
A challenge, as outlined by the Pfizer-BioNTech vaccine, is storage. M-RNA vaccines require extremely cold temperatures (less than minus 50 degrees C) that make them challenging to distribute in most of the world.
The evaluator cited earlier said that Gennova’s technology used an approach that increased the vaccine candidate’s stability and enabled it to be stored between 2-8 degrees C, a more manageable temperature range and amenable to local conditions. Dr. Singh, however, did not confirm this.
Gennova’s vaccine has been developed in collaboration with HDT Biotech Corporation, Seattle, U.S. The mRNA vaccine candidate (HGCO19) had demonstrated “safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models” and the company was working aggressively to ensure “first human injection by the end of the year”, subject to Indian regulatory approvals, the Ministry of Science & Technology had said in press release in July.