NEW DELHI: India’s apex drug regulator on Tuesday approved the phase 2 and 3 clinical trials of Covid vaccine candidate by Pune-based Gennova, which has shown very encouraging results in the early-stage trials.
Importantly, this mRNA-based vaccine will likely be compared with Covishiled, and not placebo while the trials will include about 4,400 participants at 22-24 sites across the country. Also, it may be the first vaccine to be introduced in India specifically designed against the delta variant of SARS CoV 2--the most dominant strain of the virus in India and elsewhere.
“This will be the first time that a vaccine in India will be compared with another one in a clinical trial and not placebo which will mark for a head-to-head comparison between the two vaccines,” a source in the Central Drugs Standard Control Organisation said.
The vaccine by Gennova has been developed with cooperation from the US-based HDT Biotech Corporation and has many benefits.
One of these include the fact that it uses the self-amplifying RNA that would allow more doses to be produced per batch, while the other advantage is the option to redesign the vaccine to emerging variants, a feature possible easily with mRNA platforms.
Additionally, it can be stored at 2–8-degree Celcius, which makes the vaccine’s storage and distribution easy.
Over the last few months, the company has received funding of about Rs 125 crore from the department of biotechnology of the Union government for preclinical and clinical development while the project has been closely monitored by its subject expert committee.
The government, looking to fully vaccinate all the adult population in India over the next few months is hoping to procure at least 6 crore doses of this vaccine by the year-end, provided that it proves its protective efficacy against coronavirus in the late-stage trials.
The first stage of the clinical trial of the vaccine saw it being tested on about 120 individuals in the age group of 18-70 years while animal trials of the vaccine had previously shown that its “neutralising antibody response… was comparable” with antibody levels measured in patients recovering from Covid-19.
The manufacturer of the vaccine had, last month, sought at risk production support from the Union ministry of health and family welfare—just like a Rs 1,500 crore support was granted to Bio E for its Covid19 vaccine.
The officials in the ministry told this newspaper that the government had given in-principle approval to the proposal but it will be easier to support the firm if the early data from the efficacy trials, about to begin now, are as promising.