November 01,2020: top company official para koikena janaishe ki Bharat Biotech khan plan kuri ase tai khan COVID-19 laga vaccine toh aha sal laga 2nd quarter te olabole nimete judi tai khan Indian regulatory authorities, para approval khan paishe koile toh.aro koikena janaishe tai khan laga etia laga focus toh Phase 3 trials toh desh laga jaka khan te lobole nimete ase.
Etia company’s vaccine candidate –Covaxin khan Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV) khan milaikena inactivated Sars-Cov-2,chulaikena etu virus kuntu para COVID-19 ke dikdaar dishe. Etu virus ke ICMR lab te alag kurishe.
Bharat Biotech International Executive Director Sai Prasad para PTI ke koikena janaishe “Judi ami khan sob approvals paishe koile toh strong experimental evidence aro data khan olaikena aro efficacy nimete aro safety data nimete ami khan laga last stage trials nimete ami khan etu vaccine toh 2021 laga q2 te olabole nimete aim kuri ase.”
Etu company khan approval paa pichede Drugs Controller General of India (DCGI) Phase 3 clinical trial lobole nimete etu vaccine candidate laga efficacy ola bole nimete tai khan phase 3 laga site preparatory shuru urishe recruitment aro dosages toh November te shuru kuribo.
Etu trial lobole thaka toh 25 to 30 sites te 13-14 states te duita dosage dibo vaccine niemtwe aro placebo reciepents nimete komti hoilebi 2,000 subjects khan enrol kuribole paribo hospital hisaab te.
Vaccine laga investment uporte kotha kura samay te tai koikena janaishe “ami khan laga investment toh about Rs 350-400 crore ase etu vaccine bonabole aro nutun manufacturing facilities nimete etu te ami khan laga investment Phase 3 clinical trial aha moina te lobole nimete laga bi ase.
Tai aro bi koikena janaishe ki ‘ami khan laga etia laga focus toh sites khan te Phase 3 trial toh bhal para lobole nimete laga ase.”
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