A vaccine being developed by the Pune-based Gennova has become India’s first homemade mRNA candidate to get permission for human clinical trial, the government said today. The mRNA vaccines do not use the conventional model to produce immune response.
“mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus,” a government statement read.
The mRNA vaccines are considered safe as they are “non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms”.
The vaccines developed by American companies Pfizer and Moderna, which are said to have over 90 percent efficacy, use the mRNA model.
AstraZeneca-Oxford’s Covishield vaccine, which has shown an efficacy of 70 percent and is being manufactured by the Serum Institute of India, uses the 50-year-old ‘adenovirus vector-based antigen’ platform.
The company has developed the vaccine candidate in collaborating with HDT Biotech Corporation, a US firm.
“HGCO19 (the code name for the vaccine) has already demonstrated safety, immunogenicity, neutralization antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19,” the statement read.
While the mRNA vaccines developed by the US companies require sub-zero temperature to remain stable, “HGCO19” is stable at 2-8 degrees Celsius for two months, the Centre said.
If approved, the new vaccine could prove to be more effective in the Indian conditions as it remains stable in normal refrigerator temperature and eliminates the need to develop cold storage infrastructure in remote parts of the country.
Three COVID-19 vaccine candidates, developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India’s drug regulator, the Union health ministry said earlier this week.
On Thursday, the requests for emergency use of vaccines being manufactured by the Serum institute and Bharat Biotech were not cleared by a committee of health experts. Both companies have been asked to submit more data at the next meeting, the date of which has not yet been decided.
The Centre and states have been preparing a detailed plan for vaccine distribution. Last month, Prime Minister Narendra Modi held a meeting with the chief ministers of all the states. Sources said prioritising inoculation of frontline health workers and the elderly was discussed in the meeting.