Gennova Biopharma seeks DCGI nod for its Omicron booster

Gennova Biopharma seeks DCGI nod for its Omicron booster

Gennova Biopharmaceuticals, subsidiary of Pune-based drugmaker Emcure has submitted data for its mRNA-based Omicron specific Covid-19 booster shot for authorisation to the drug regulator, amid increase in the number of Covid-19 cases, a person i the know told ET.

Gennova has developed an Omicron specific vaccine GEMCOVAC-OM which has been assessed for its safety and immunogenicity when administered as a booster in participants who have received two doses of Covishield and Covaxin, the two main Covid-19 vaccines used in the immunisation drive.

The company has conducted Phase II/III trials and results have been submitted to the drug controller General of India (DCGI). “The trial results show that GEMCOVAC®-OM was found to be safe and well tolerated and no vaccine related serious adverse events were observed. Moreover, the vaccine demonstrated superior immune response,” a top executive in the company said.

Gennova’s vaccine will be a needle free delivered intradermally using a device called Tropis developed by Pharmajet instead of traditional syringes, eliminating the fear and anxiety associated with needles like needle phobia, sharps disposal, and needle-stick injuries.

“The device has been used to administer to millions of children for polio vaccination and has demonstrated increased preference for this route of delivery, ” added the same person.

Gennova has finished its trial on 3200 participants.

“mRNA technology provides a high degree of flexibility, speed, and specificity to produce a variant-specific vaccine compared to other traditional platforms”, Sanjay Singh, CEO of Gennova had earlier told ET.The vaccine is stable at normal temperature, stable at 2- 8 °C and could be distributed through the already existing refrigeration supply chain Pan-India and in lower and middle income countries. (LMICs).

“The highlight of this mRNA vaccine is its self-amplifying nature, hence requires a low dose and has shown a robust immunogenic response to fight Covid-19 disease currently approved for people above 18 years of age. The vaccine can be made available in the most remote parts of India because it does not require ultra-low temperature storage, which could have been a major hurdle for mRNA vaccines becoming a reality in India,” the executive said.

So far the vaccines which have been currently approved used as precautionary doses are against the ancestral strain. Once approved, this will be the first booster vaccine targeting the Omicron variant. “A booster vaccine developed to target the Omicron variant is needed as the other vaccines, though can increase the antibody titers, their ability to neutralize the circulating Omicron variant of SARS-CoV-2 is limited,”said an expert.

India continues to witness an uptick in Covid-19 cases. The country saw a single-day rise of 918 fresh coronavirus cases and four deaths, while active cases rose to 6,350, according to the Union health ministry data updated on Monday.

On Sunday 1,070 fresh Covid cases were registered across the country, the highest in four months. The last time India registered over 1,000 Covid cases was on November 6, 2022.

(With inputs from health)