Currently, 12 lakh booster doses of GemCOVAC-OM are accessible at the Central Drugs Laboratory (CDL), Kasauli, which is in charge of national regulations for indigenously produced vaccines for the domestic market.
Digital Desk: The Drugs Controller General of India (DCGI) granted emergency use authorization to Pune-based Gennova Biopharmaceuticals on Tuesday for its mRNA COVID-19 booster vaccine, GEMCOVAC-OM, against the Omicron strain of SARS-CoV2. "In the country, a booster dose against SARS-CoV2 is still required." Original vaccinations were ineffective against the Omicron lineage. "An updated vaccine is required, and yes, we anticipate sufficient market demand for the precautionary dose," Dr Sanjay Singh, CEO of Pune-based Gennova Biopharmaceuticals Ltd, said today.
The debut is scheduled for two to three weeks in New Delhi, where pricing and estimated demand will be announced. Currently, 12 lakh booster doses of GemCOVAC-OM are accessible at the Central Drugs Laboratory (CDL), Kasauli, which is in charge of national regulations for indigenously produced vaccines for the domestic market.
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More than 220 crore doses of Covid vaccine have been provided in the country so far, and according to government figures, approximately 24% of the fully vaccinated population in the country had gotten booster shots as of April this year. According to the Union Ministry of Health and Welfare, active Covid cases now account for 0.01 percent of total infections. Dr Singh is undeterred by the stream of questions presented at a virtual media conference on the importance of a booster dose in such a setting, with Covid lying low and a tepid adoption of boosters across the country. "In phase 3 clinical trials conducted at 20 centres across 13 cities in India, GEMCOVAC-OM demonstrated robust immune responses." GEMCOVAC-OM was administered to roughly 3,000 people in Phase II/III trials, and the vaccine was shown to be safe and well tolerated. The current vaccinations approved for use as precautionary/booster doses are meant to protect against the ancestral strain of SARS-CoV-2. Although they will raise antibody titers, their potential to neutralise the circulating SARS-CoV-2 Omicron form is limited. Developing antibodies and memory immune responses unique to the Omicron variety might minimise the likelihood of infection and hospitalisation, as well as avoid subsequent pandemic waves. "The Made-in-India GEMCOVAC-OM addresses this gap specifically," he stated.
"We are the third company, after top US biotech firms Moderna and Pfizer, to develop an mRNA COVID-19 booster vaccine - the first in India - against the highly transmissible Omicron variant," Dr Singh added.
Those above the age of 18 can receive the vaccine as a booster dose. Individuals who have gotten two doses of either Covaxin or Covishield can receive this safely. The vaccine is lyophilized (freeze-dried) and stable at 2-8 °C.
"There is an acceptance that COVID-19 will persist and mutate, and that we must be prepared with vaccines to deal with emerging variants." "The mRNA platform, which was developed in collaboration with the Department of Biotechnology, Government of India, allows for a quick turnaround for vaccine development for any future variants of concern, if any," he added. "Gennova has successfully developed India's first Omicron-variant vaccine within a few months," stated Samit Mehta, COO of Gennova Biopharmaceuticals Limited. Given the global accessibility issues for the COVID-19 vaccines, we are pleased to provide a vaccination based on cutting-edge technology, the mRNA."
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