India Pharma Outlook Team | Tuesday, 21 March 2023
A person in the know informed sources that Gennova Biopharmaceuticals, a subsidiary of Pune-based drugmaker Emcure, has filed data for its mRNA-based Omicron specific Covid-19 booster shot for approval to the drug regulator, despite an increase in the number of Covid-19 cases. Gennova has developed an Omicron-specific vaccine, GEMCOVAC-OM, which has been tested for safety and immunogenicity when given as a booster to participants who have already received two doses of Covishield and Covaxin, the two primary Covid-19 vaccines used in the immunization campaign.
The company has completed Phase II/III trials, and the findings have been submitted to India's Drug Controller General. (DCGI). "The trial results indicate that GEMCOVAC®-OM was found to be safe and well tolerated and no vaccine related serious adverse events were noted. Furthermore, the vaccine showed superior immune response," a business executive stated.
Gennova's vaccine will be delivered intradermally without the use of needles, using a device called Tropis created by Pharmajet instead of traditional syringes, eliminating the fear and anxiety associated with needles such as 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 completed its 3200 participant study.
"When compared to other traditional platforms, mRNA technology provides a high degree of flexibility, speed, and specificity to produce a variant-specific vaccine," Sanjay Singh, CEO of Gennova, previously told sources. The vaccine is stable at normal temperatures, stable at 2- 8 °C, and could be distributed through the existing refrigeration supply chain in Pan-India as well as lower and medium income nations. (LMICs).
"The highlight of this mRNA vaccine is its self-amplifying nature, which necessitates a low dose and has demonstrated a robust immunogenic response to combat Covid-19 disease, which is presently authorized for people over the age of 18. Because it does not require ultra-low temperature storage, the vaccine can be made accessible in the most remote areas of India, which could have been a significant barrier to 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.
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