Indian Expert Panel Recommends Emergency Use Approval for Covaxin in 2 to 18 Age Group
An expert panel of India’s Central Drug Authority has recommended granting emergency use authorisation to Bharat Biotech’s Covaxin for children in the 2 to 18 years age group with certain conditions, sources said on Tuesday.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
”After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the SEC recommendations stated.
The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations stated.
After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the 2 to 18 years age group for restricted use in emergency situations subject to certain conditions, they stated.
According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet, a source said.
Besides, the firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs and Clinical Trials Rules, 2019.
Next Story:
-
Hyderabad DCC to launch awareness campaign for caste census
![Hyderabad DCC to launch awareness campaign for caste census]()
Hyderabad, November 2: Telangana Pradesh Congress Committee (TPCC) president Mahesh Kumar Goud has instructed Congress workers across the Hyderabad district to ensure efficient coordination for a successful caste census being conducted by the state government.
-
Special Buses For Devotees To Shaivite Shrines During Kartika Masam
![Special Buses For Devotees To Shaivite Shrines During Kartika Masam]()
Hyderabad, Nov 2 (Maxim News): Special buses were being arranged for the convenience of devotees to famous Shaivite shrines during the holy month of Kartika, announced Telangana State Road Transport Corporation (TGSRTC) Managing Director VC Sajjanar here on Saturday. These special buses will be run from Hyderabad to Srisailam, Vemulawada, Dharmapuri, Keesaragutta, and other temples.
-
Cruise Ship Service From Nagarjuna Sagar To Srisailam Launched
![Cruise Ship Service From Nagarjuna Sagar To Srisailam Launched]()
Nagarjuna Sagar/Hyderabad, Nov 2 (Maxim News): Tourists and nature lovers have been waiting for the boat journey from Nagarjuna Sagar to Srisailam on the first day of the month of Kartika started by the Telangana Tourism Department.
-
Man Involved In Forgery And Cheating Arrested
![Man Involved In Forgery And Cheating Arrested]()
Hyderabad, Nov 2 (Maxim News): The EOW Police of Cyberabad arrested an accused person, Udandapuram Narsimlu, R/o Shivampet Mandal, Medak district who was involved in forgery and cheating. The accused has created the fabricated and forged documents in respect of government land of Allipur village, Shivampet Mandal, Medak district and made believe the complainant as…
-
Yakutpura Fire Accident: Death Toll Surge To Three
![Yakutpura Fire Accident: Death Toll Surge To Three]()
Hyderabad, Nov 2 (Maxim News): A teenager Shruthi Gupta, who was injured during a fire accident at Chandanagar, Yakutpura last week, passed away while undergoing treatment at Gandhi Hospital early on Saturday.
Now you can get latest stories from Indtoday on Telegram everyday. Click the link to subscribe. Click to follow Indtoday Facebook page and Twitter and on Instagram. For all the latest Hyderabad News updates
