Gennova submits phase 2 trial data of mRNA vaccine for DGCI approval

Gennova mRNA vaccine: Gennova Biopharmaceuticals, a Pune-based pharmaceutical company, has submitted phase 2 trial data of its mRNA COVID-19 vaccine for approval. The Drugs Controller General of India's (DCGI) Subject Expert Committee (SEC) is expected to review the data soon.

Gennova Biopharmaceuticals has also completed the recruitment of phase 3 clinical trial data. The pharma company has also developed the mRNA vaccine for the Omicron variant of COVID-19 that will be tested on humans for efficacy & immunogenicity soon. 

Gennova Biopharmaceuticals is a subsidiary of Pune-based drugmaker Emcure.

Gennova Biopharmaceuticals has also developed the mRNA vaccine for the #Omicron variant that will be tested on humans for efficacy & immunogenicity soon: Official sources

— ANI (@ANI) January 17, 2022

Gennova mRNA vaccine Trials

• Gennova had started Phase-2 and Phase-3 clinical trials of its mRNA-based vaccine- HGCO19-across 35 centres in India last year. 

• The phase 2 study was conducted on 400 healthy subjects. The Phase III study will enroll 4000 healthy subjects who are 18 years and above and up to 80 years.

• The company scaled up recruitment in its phase 2 and 3 trials and added more centres to enable the same. The phase 3 trials of the mRNA vaccine will be conducted at 22-24 sites across the country. 

• The phase 1 trial of Gennova's mRNA vaccine had started during the second wave of the COVID-19 pandemic. At that time, the company had faced challenges in recruiting clinical trial participants as people were worried about coming to hospitals.

• The company also had exclusion criteria of seronegative volunteers, who have not been exposed to the virus yet. The company was then doing the trials in only two centres, as a result of which they faced a lot of challenges and it also took a lot of time to complete the trial.

About Gennova's mRNA Vaccine

The mRNA vaccine will be using Covishield as a comparator in its phase 3 trials, which is expected to speed up the trial process. The early vaccines were tested against placebo in phase 3 trials. 

The mRNA vaccine may be the first vaccine to be introduced in India specifically designed against the Delta and Omicron variant of COVID-19.

The vaccine has been developed by Gennova with cooperation from the US-based HDT Biotech Corporation.

Benefits of the vaccine 

The Gennova mRNA vaccine uses the self-amplifying RNA that would allow more doses to be produced per batch.

The vaccine can be redesigned to fight the emerging variants of COVID-19. This feature is possible easily with mRNA platforms. 

The vaccine can be stored at 2–8-degree Celcius, which makes its storage and distribution easy. 

Efficacy of the vaccine

Gennova had earlier submitted the interim Phase-1 clinical trial data to CDSCO, where it was tested for safety and immunogenicity. The company will also publish the data in a scientific journal.

The phase 1 trials of the vaccine involved 120 individuals in the age group of 18-70 years. The animal trials of the vaccine had previously shown its “neutralising antibody response", which was comparable with antibody levels measured in patients recovering from Covid-19. 

Booster dose 

Gennova is now looking at the possibility of conducting separate trials to test its mRNA vaccine both for booster dose to other vaccines and for use on children. 

According to Samit Mehta, chief operating officer of Emcure and director on the Board of Gennova , "The global data supports mNRA vaccines as booster dose and for that matter pediatric use given their safety track record and immunogenicity."

Background 

Gennova has received Rs 125 crore from the Indian government as seed capital and conducting trials. The government has also committed to source at least 60 million vaccine doses from the company. 

One of Emcure's plant in Pune had been repurposed to manufacture the mRNA COVID vaccine with a capacity to make up to 200 million doses, which can be scaled up to 1 billion doses.

The centre is aiming to fully vaccinate all its adult population in India over the next few months.