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:
-
Adani Bribery Case: KTR Demands Telangana Govt To Cancel All Contracts
![Adani Bribery Case: KTR Demands Telangana Govt To Cancel All Contracts]()
Hyderabad, Nov 22 (Maxim News): BRS working president KT Rama Rao demanded the Congress government in Telangana to cancel its agreements with the Adani Group, worth Rs 12,400 crore, and return the Rs 100 crore donation made by the group for the Skill University. The demand follows charges of corruption and bribery against industrialist Gautam Adani…
-
Raja Singh Sparks Controversy Again: Advises Ayyappa Devotees’ To Visit Vavar Mosque
![Raja Singh Sparks Controversy Again: Advises Ayyappa Devotees’ To Visit Vavar Mosque]()
Hyderabad, Nov 22 (Maxim News): Goshamahal BJP MLA Raja Singh, sparked controversy after advising Ayyappa Swamy devotees not to visit the Vavar mosque of Hazrath Vavarswami Darga and mosque—popularly known as Vavar mosque—when traveling to the Sabarimala Temple in Kerala.
-
Telangana: DCA Cracks Down On Fake Drug Claims For Critical Illness
![Telangana: DCA Cracks Down On Fake Drug Claims For Critical Illness]()
Hyderabad, Nov 22 (Maxim News): The Drug Control Administration (DCA), Telangana State seized several drugs that were circulating in the market with misleading claims of treating Cardiovascular disorders, blood pressure, Ophthalmic diseases/disorders, fevers, and diabetes, which is in contravention of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, a DCA press release said.
-
Three Arrested For Practicing Allopathy In Telangana
![Three Arrested For Practicing Allopathy In Telangana]()
Hyderabad, Nov 22 (Maxim News): The drug inspectors of Telangana State Drug Control Administration (TSDCA) conducted raids on the premises of three quacks (unqualified medical practitioners), who were practicing allopathy, at different locations in Telangana State and seized substantial stocks of medicines worth Rs. 83,000, stored illegally for sale.
-
Like Praja Palana Forms, Now Caste Survey Applications On Road
![Like Praja Palana Forms, Now Caste Survey Applications On Road]()
Hyderabad, Nov 22 (Maxim News): The caste census survey applications have been found scattered again and this time near Tarnaka Metro station in the city on Friday. This is the second such incident being reported in the State.
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
