Search For "immunogenicity data"
SEC recommends Dr Reddy's to submit additional data for EUA of Sputnik V C
Updated : 5 years, 5 months ago IST
New Delhi [India], February 24 (ANI): The Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Committee (SEC) has recommended additional immunogenicity data from Dr Reddy's Laboratories which applied to the national drugs regulator seeking emergency use approval for Sputnik
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Pfizer showed no plans to generate safety data in Indian population for CO
Updated : 5 years, 5 months ago IST
New Delhi [India] February 5 (ANI): The subject expert panel of Drugs Controller General of India did not recommend granting emergency use authorisation to Pfizer's COVID-19 vaccine noting that the firm has not proposed plans to generate safety and immunogenicity data concerning Indian popu
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Emergency use of vaccine is based on safety, immunogenicity data, says ICM
Updated : 5 years, 6 months ago IST
New Delhi [India], January 5 (ANI): The Indian Council of Medical Research (ICMR) director Dr Balram Bhargava on Tuesday said that in a pandemic situation, restricted emergency use of the vaccine is considered based on phase 2 safety and immunogenicity clinical trial data while phase thre
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Submit previous trial data for Covaxin before rolling out phase III: Drug
Updated : 5 years, 9 months ago IST
New Delhi [India], October 10 (ANI): The expert panel at Central Drugs Standard Control Organisation (CDSCO) has asked drug maker Bharat Biotech to submit safety and immunogenicity data from ongoing phase II trial in order to conduct phase III clinical trial of indigenous COVID-19 vaccine, C
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