Hyderabad-based Biological E’s Corbevax vaccine clinical trial study in children has 624 children aged 5 years to 18 years, according to the Clinical Trial Registry of India at ten trial sites across the country.
According to the Clinical Trial Registry of India at ten trial sites across the country – Three in Karnataka. The three trial sites in Karnataka are KLES Dr Prabhakar Kore Hospital and Medical Research Centre in Belagavi, Cheluvamba Hospital attached to Mysore Medical College and Research Institute, JSS Medical College and Hospital in Mysuru.
Principal Investigator Dr Niranjana S Mahantshetti of the Department of Paediatrics, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi, told to Deccan herald that , “We have not completed the trial yet. So far, we have had no problems in terms of side effects. We don’t know about the immunogenicity or the antibody levels yet. We have 55 subjects, out of which 24 completed both doses. Most kids already had Covid antibodies and such children can’t be part of the trial.”
CORBEVAX is a recombinant protein subunit vaccine against the novel coronavirus and has been given emergency use authorisation (EUA) for children aged 12-18 years and adults from 18-80 yrs. The vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius.
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Biological E had begun the manufacturing CORBEVAX for stockpiling after approval, based on the favourable clinical evidence and review by experts. Multiple Biological E. Limited facilities in Hyderabad are currently producing and will continue to produce the vaccine. The group will leverage its robust pan India presence and partner with the State Governments, hospitals and Medical institutions to leave no stone unturned in facilitating the uninterrupted supply of the COVID-19 vaccine. To date, 30 crore vaccines have been produced as part of the commitment made to the Government of India. Biospectrum Deccan Herald