DCGI nod to Covaxin for use in children above 12 years PM announces jabs for 15-18 years
New Delhi Dec 25 PTI The Drugs Controller General of India DCGI has granted emergency use authorisation to indigenously-developed Bharat Biotechs Covaxin for children above 12 years with certain conditions official said on SaturdayIt is the second vaccine to receive the regulators nod for use among those below 18 years after Zydus Cadilas needle-free COVID-19 vaccine ZyCoV-DLater in the night Prime Minister Narendra Modi announced that Covid vaccination for children between 15 and 18 years will start from January 3The Subject Expert Committee on COVID-19of the Central Drugs Standard Control Organisation CDSCO on October 11 after deliberating Bharat Biotechs emergency use authorisation EUA application had recommended granting emergency use approval to Covaxin for use in the 2-18 years age group with certain conditionsThe recommendations of the SEC were further evaluated and examined after which DCGI had sought additional data from the firm an official saidThe DCGI gave its approval Friday the official said Based on the recommendations of SEC experts and submission of additional safety data this directorate has no objection at this stage for additional indication of Whole Virion inactivated corona virus vaccine for use in age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in emergency situation with the condition to submit SmPC PI Factsheet incorporating clinical information for said age group along with pharmacovigilance risk management plan the DCGI approval order issued saidHyderabad-based Bharat Biotech which completed the phase 23 trials of Covaxin for use among those aged between 2 and 18 years had submitted the data to CDSCO for its verification and subsequent approval for emergency use authorisation EUA for the jab in the beginning of OctoberIt had presented its proposal for grant of market authorisation of its Whole Virion Inactivated coronavirus Vaccine BBV152 in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 23 clinical trial conductedReacting to the development Bharat Biotech in a statement said Covaxin is formulated uniquely such that the same dosage can be administered to adults and children Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants We have documented excellent safety and immunogenicity data readouts in children We look forward for Covaxin to provide similar levels of protection for adults and children alike The DCGI on September 1granted permission to Hyderabad-based Biological E Limited to conduct phase 23 clinical trial of its made in India COVID-19 vaccine on children and adolescents aged between 5 and 18 years with certain conditionsIn July it had granted permission to Serum Institute of India SII for conducting phase 23 trials of Covovax on children aged 2 to 17 years with certain conditions PTI PLB ZMN
New Delhi Dec 25 PTI The Drugs Controller General of India DCGI has granted emergency use authorisation to indigenously-developed Bharat Biotechs Covaxin for children above 12 years with certain conditions official said on SaturdayIt is the second vaccine to receive the regulators nod for use among those below 18 years after Zydus Cadilas needle-free COVID-19 vaccine ZyCoV-DLater in the night Prime Minister Narendra Modi announced that Covid vaccination for children between 15 and 18 years will start from January 3The Subject Expert Committee on COVID-19of the Central Drugs Standard Control Organisation CDSCO on October 11 after deliberating Bharat Biotechs emergency use authorisation EUA application had recommended granting emergency use approval to Covaxin for use in the 2-18 years age group with certain conditionsThe recommendations of the SEC were further evaluated and examined after which DCGI had sought additional data from the firm an official saidThe DCGI gave its approval Friday the official said Based on the recommendations of SEC experts and submission of additional safety data this directorate has no objection at this stage for additional indication of Whole Virion inactivated corona virus vaccine for use in age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in emergency situation with the condition to submit SmPC PI Factsheet incorporating clinical information for said age group along with pharmacovigilance risk management plan the DCGI approval order issued saidHyderabad-based Bharat Biotech which completed the phase 23 trials of Covaxin for use among those aged between 2 and 18 years had submitted the data to CDSCO for its verification and subsequent approval for emergency use authorisation EUA for the jab in the beginning of OctoberIt had presented its proposal for grant of market authorisation of its Whole Virion Inactivated coronavirus Vaccine BBV152 in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 23 clinical trial conductedReacting to the development Bharat Biotech in a statement said Covaxin is formulated uniquely such that the same dosage can be administered to adults and children Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants We have documented excellent safety and immunogenicity data readouts in children We look forward for Covaxin to provide similar levels of protection for adults and children alike The DCGI on September 1granted permission to Hyderabad-based Biological E Limited to conduct phase 23 clinical trial of its made in India COVID-19 vaccine on children and adolescents aged between 5 and 18 years with certain conditionsIn July it had granted permission to Serum Institute of India SII for conducting phase 23 trials of Covovax on children aged 2 to 17 years with certain conditions PTI PLB ZMN
