Expert panel recommends emergency use approval for Covaxin in 2 to 18 age group
New Delhi, Oct 12: 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 recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.
The company 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 2/3 clinical trial conducted.
The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26, the sources said.
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.
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Poll affidavit: Modi's assets total Rs 3 crore, mostly fixed deposits
Varanasi (UP), May 14: Prime Minister Narendra Modi possesses assets amounting to a little over Rs 3 crore, most of it in bank fixed deposits, according to his election affidavit.
As required, Modi submitted the affidavit while filing his nomination papers Tuesday as an election candidate from the Varanasi parliamentary constituency, a seat he has held twice earlier.
According to the affidavit displayed on the Election Commission website, his movable assets are worth Rs 3,02,06,889. Most of this amount is in the form of fixed deposits with the State Bank of India that total over 2.85 crore.
Other assets include four gold rings weighing 45 grams valued at Rs 2.67 lakh, cash in hand totalling Rs 52,920, National Savings Certificates worth Rs 9.12 lakh and income tax deduction of Rs 3.33 lakh for the past financial year.
Under “immovable assets”, the affidavit says "Nil". Typically, land and houses fall under this category.
Jashodaben is mentioned as Modi’s spouse. On assets held by her, the document says "Not known". The two live apart.
No criminal case is pending against Modi, nor has he been convicted of any crime, according to the document. There are no liabilities due to the government.
The prime minister is described as a resident of Ahmedabad, and his profession as public life and political activity.
He did his SSC in 1967, got a BA degree from Delhi University in 1978 and an MA from Gujarat University in 1983.
In the 2019 Lok Sabha elections, Modi had declared assets worth Rs 2.5 crore including a residential plot in Gujarat's Gandhinagar, fixed deposits of Rs 1.27 crore and Rs 38,750 cash in hand.
In the 2014 Lok Sabha elections, he disclosed total assets of Rs 1.65 crore.
The PM has a website and is on Facebook, microblogging site X, YouTube, Instagram and WhatsApp, according to the affidavit.
