In the wake of the rising cases of Omicron variant of novel coronavirus, the Union government is in discussion with Pune-based Gennova Biopharmaceuticals Ltd to consider its mRNA vaccine for booster dose.
Gennova’s messenger RNA or mRNA vaccine is in the late-stage trial. It has completed phase 2 studies and has progressed well in the third phase, News18 reported.
“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),” the report said quoting a senior government health ministry official.
The Department of Biotechnology had earlier provided seed funding for the development of Gennova's novel self-amplifying mRNA-based vaccine candidate for COVID-19. In collaboration with HDT Biotech Corporation, USA, Gennova has developed an mRNA vaccine candidate (HGCO19), with demonstrated safety, immunogenicity, neutralisation antibody activity in the rodent and non-human primate models, the report said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The company now plans to initiate trials for booster dose and for use among children after completing the ongoing trials, said the report said quoting the above mentioned official. He further added that “the discussions over the booster dose have already begun with the DCGI. We have hinted that they can start trials on boosters soon…”
Reportedly, Gennova’s vaccine could be a “big opportunity for India” as global studies show mRNA works as good boosters.
Prime Minister Narendra Modi on December 25 announced that a third dose would be given to those who have been vaccinated twice but are over 60 and suffer from comorbidities.
In a press conference on December 24, ICMR Director General Balram Bhargava said discussions are going on to look at different aspects of booster dose."There is a COVID working group, which has debated on it several times that those recommendations to the subcommittee of the National Technical Advisory Group of immunisation following which it goes to the main technical advisory group of immunisation and then to NEGVAC which will then be accepted by the Ministry of Health," he said. "So, deliberations are going on and we are reviewing all the scientific data from across the world as well as from India. We are deliberating and we are formulating our policy," he said.