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16,000 medical staff trained in Maharashtra for vaccine drive: Rajesh Tope
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Bharat Biotech to submit additional data for vaccine s emergency approval
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India’s homegrown candidate vaccine against the novel coronavirus disease developed by the Hyderabad-based Bharat Biotech has generated a dual immune response that has raised hopes of immunity lasting six to 12 months.
The candidate vaccine named Covaxin generated anti-coronavirus antibodies and stirred immune memory cells in the vaccinated volunteers, researchers with Bharat Biotech and the Indian Council of Medical Research said in a scientific paper released on Wednesday.
The paper, describing the results of safety and immunogenicity trials in 380 volunteers in nine hospitals across the country, has also reported similar immune responses across age groups. The trials offered the candidate vaccine to volunteers aged between 12 years up to 65 years.
Serum seeks marketing nod for Covishield
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The SII application appears to be lacking the immunogenicity data from the phase-3 trials which experts say as per timelines would not have been ready by now.
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AstraZeneca-Oxford University proposal for emergency use authorisation is currently under evaluation with the UK regulator.
New Delhi: Pune-based Serum Institute of India (SII) has approached India’s drug regulator once again seeking marketing authorisation for its potential Covid-19 vaccine. The firm has submitted updated data as required by the expert panel, people in the know told ET. “SII has submitted full dose efficacy data of the UK trials and safety data from its own phase-3 trials which are ongoing in India,” said one of these people.
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