• India’s first mRNA-based Omicron-specific booster vaccine has been authorized

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    India’s first mRNA-based Omicron-specific booster vaccine has been authorized

    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."