The government is in discussion with Pune-based Gennova Biopharmaceuticals to consider its mRNA vaccine for booster dose, News18.com has learnt. A subsidiary of Pune-based drugmaker Emcure, Gennova’s Messenger RNA or mRNA vaccine is in the late-stage trial where it has completed phase 2 studies and has progressed well in the third phase.
“By the end of January, next year, the company is hoping to complete the trial and apply for gaining emergency use authorisation from the drug controller general of India (DCGI),” a senior government official at the Ministry of Health and Family Welfare, told News18.com.
He said the company plans to initiate trials for booster dose and for use among children as soon as they conclude the ongoing trials.
“The discussions over the booster dose have already begun with the DCGI. We have hinted that they can start trials on boosters soon…”
The officer, who is privy to the development, said, “This vaccine could be a big opportunity for India as global studies show mRNA works as good boosters.”
In fact, top vaccine expert Dr Gagandeep Kang, in an interview to News18.com, had urged the Narendra Modi government to figure out a way to bring mRNA vaccines to India, saying data shows it to be the best booster shot against Covid-19.
Dr Kang, also a Professor of Microbiology at Christian Medical College in Vellore, pointed that India can also wait for its own mRNA platform by Gennova Biopharmaceuticals.
India did not give up on the demand for signing indemnity bonds with the US drugmakers Pfizer and Moderna – the makers of mRNA-based vaccines, which have been supplied across the globe, mostly to the developed world.
The COV-BOOST study, published in TheLancet, found that a full or half dose of Pfizer or a full dose of Moderna gave a strong boost to both antibody and T-cell levels, regardless of whether the person initially received Pfizer or AstraZeneca – known as Covishield in India.
While available mRNA vaccines require ultra-cold storage of around -70 degree Celsius, Gennova’s technology is much easier to store and transport as it requires temperature of around 2-8 degree Celsius — the usual temperature that every other vaccine would need.
“The company was already in discussion with the government on the pricing of their vaccine considering it’s a different technology and they have innovated in stabilising the vaccine on room temperature.”
However, now, as more than 80% of the population have already taken their first dose, the government’s interest is sharply inclined towards booster shots and vaccines for children.
mRNA technology involves injecting a small part of the virus’s genetic code (RNA) to stimulate the recipient’s immune response. It contains instructions for human cells to make proteins that mimic part of the novel coronavirus, spurring the immune system into action. No actual virus is contained in the vaccines.
Top mRNA vaccines available across countries are Pfizer-BioNtech and Moderna’s shots.