Bharat Biotech Submits Clinical Trial Data of Covaxin in Children to CDSC
3 years, 2 months ago

Bharat Biotech Submits Clinical Trial Data of Covaxin in Children to CDSC

News 18  

Bharat Biotech, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children under 18 years of age, has submitted the data to the Central Drugs Standard Control Organisation for its verification and subsequent approval for Emergency Use Authorisation for the jab, company sources said on Wednesday. ?Covaxin clinical trial data of 2-18 years age group has been submitted to CDSCO?This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase 1,2 and 3 clinical trials in adults,? Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella, had said on September 21 that the Paediatric Covaxin completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on. As part of the Phase II/III trial, the two-dose Covaxin was administered with 28 days apart.

History of this topic

The right way to counter a poor Covaxin safety study
4 months, 3 weeks ago
BHU study: Over 30 per cent of Covaxin recipients report adverse events
7 months, 1 week ago
‘Safety is primary focus’: Covaxin-developer amid reports on AstraZeneca vaccine
7 months, 3 weeks ago
Nasal vaccine at govt centres in Delhi from Feb 15
1 year, 10 months ago
COVID-19: Mansukh Mandaviya launches world's 1st Made-in-India nasal vaccine iNCOVACC
1 year, 10 months ago
First Indian intranasal Covid vaccine by Bharat Biotech to be launched on Jan 26
1 year, 11 months ago
DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose
1 year, 11 months ago
Covid: 250 million Corbevax, Covaxin in stock, ready for dispatch
1 year, 11 months ago
Biological E, Bharat Biotech have stockpile of 250 million COVID vaccine doses
1 year, 11 months ago
Nasal vaccines to roll out in private hospitals soon
2 years ago
Bharat Biotech’s nasal vaccine to be available as booster dose
2 years ago
COVID-19: Centre approves Bharat Biotech's intranasal vaccine, to be available on CoWIN
2 years ago
Indian Army issues advisory on Covid, asks defence personnel to take safety measures
2 years ago
SII Seeks Drug Regulator's Nod for Market Authorisation of Covovax Vaccine as Covid-19 Booster Dose
2 years ago
World’s first intra-nasal vaccine for COVID gets CDSCO nod for restricted use
2 years ago
CDSCO nod for Bharat Biotech’s COVID-19 intranasal vaccine under restricted use
2 years ago
Bharat Biotech’s nasal covid vax gets CDSCO’s nod as heterologous booster
2 years ago
Bharat Biotech misstated Covaxin trial data
2 years ago
Govt, Bharat Biotech Deny ‘Shortcut’ in Covaxin Trials: What's the Controversy?
2 years, 1 month ago
50 million doses of Covaxin set to expire early 2023 due to poor offtake
2 years, 1 month ago
COVID: 50 million Covaxin doses set to expire early 2023 due to poor off take
2 years, 1 month ago
COVID-19: Delhi High Court Closes Plea Challenging Centre's Permission For Clinical Trials Of Covaxin Among 2-18 Yrs Old
2 years, 3 months ago
Bharat Biotech’s intra-nasal COVID vaccine gets emergency use approval
2 years, 3 months ago
COVID-19 intranasal vaccine Phase III trials over, proven safe, says Bharat Biotech
2 years, 4 months ago
Corbevax Likely to be Available As Covid Booster Dose at Vaccination Centres from Friday
2 years, 4 months ago
Corbevax as Covid booster for adults from August 12. Check details
2 years, 4 months ago
Corbevax approved as precaution dose for adults vaccinated with Covaxin, Covishield
2 years, 4 months ago
Corbevax approved as booster for those jabbed with Covishield, Covaxin: Report
2 years, 4 months ago
Corbevax approved as precaution dose for adults vaccinated with Covaxin, Covishield
2 years, 4 months ago
In A First, Biological E's Corbevax Approved As Covid Booster for Covishield, Covaxin Recipients
2 years, 4 months ago
Corbevax approved as precaution dose for adults vaccinated with Covaxin, Covishield
2 years, 4 months ago
Govt Nod for Corbevax as Booster for Adults Vaccinated with Covishield, Covaxin Soon
2 years, 4 months ago
Adults may get different vaccine as booster shot instead of Covishield, Covaxin
2 years, 4 months ago
India supplied 23.9 crore COVID-19 vaccine doses to 101 countries, UN entities: Centre
2 years, 5 months ago
India's Covid Vaccinations Hit 200 Crore Mark in Big Milestone for 7-Phase Drive Under Modi's Leadership
2 years, 5 months ago
India's cumulative Covid-19 vaccination nears 200 crore
2 years, 5 months ago
Free COVID-19 booster shots for all adults for 75 days from July 15 at government centres
2 years, 5 months ago
NTAGI Panel Recommends Use of Covid Vaccines Corbevax, Covaxin for Kids Aged 5-12 Years
2 years, 5 months ago
Corbevax, Covaxin vacines get nod for use among 5-12 years olds; details here
2 years, 5 months ago
Serum Institute gets govt nod to export 32.4 lakh doses of Covovax vaccine to US
2 years, 5 months ago
Serum Institute’s Covovax approved by DCGI for children aged 7 to 12 years
2 years, 5 months ago
Allowing Corbevax as booster for those vaccinated with Coivishield, Covaxin likely to be considered by NTAGI
2 years, 5 months ago
Govt Panel Recommends Emergency Approval for SII's Covovax for 7-11 Year Olds
2 years, 6 months ago
Over 42 lakh deaths in India prevented by COVID-19 vaccines in 2021: Lancet study
2 years, 6 months ago
Bharat Biotech Nasal Covid Vaccine's Phase 3 Trials Completed
2 years, 6 months ago
COVID-19: Nasal vaccine's phase 3 trial completed, informs Bharat Biotech chief
2 years, 6 months ago
Covaxin demonstrates robust safety and immunogenicity in children 2-18 years: Bharat Biotech
2 years, 6 months ago
Covaxin safe, well-tolerated in 2-18 years age-group, announces Bharat Biotech
2 years, 6 months ago
NTAGI to Review Covaxin, Corbevax Data for 6-12 Yrs Thursday, Discuss Reducing Booster Dose Gap
2 years, 6 months ago
Corbevax Gets DCGI Approval As Covid-19 Vaccine Booster Dose For 18 Years And Above
2 years, 6 months ago

Discover Related