No Result
View All Result
  • MISSION STATEMENT
  • CONTACT
  • BE PART OF QUALITY JOURNALISM
  • ARCHIVE
Friday, September 22, 2023
E-Paper
Kashmir Observer
17 °c
Srinagar
  • NEWSLIVE
    • TOP STORIES
    • LOCAL
    • CITY
    • REGIONAL
    • WORLD
  • IN DEPTH
    • FEATURE
    • HEADS & TAILS
    • OPINION
      • OPINION
      • EDITORIAL
      • KO ANALYSIS
      • LETTERS TO EDITOR
    • SPECIAL REPORT
    • INTERVIEW
    • REVIEW
      • BOOKS
    • LONGFORM
  • BUSINESS
    • BUSINESS NEWS
    • MARKET
    • ENERGY
    • HORTICULTURE
    • HANDICRAFTS
    • CARS & BIKES
    • STARTUP KASHMIR
  • SPORT
    • FOOTBAL
    • CRICKET
    • ADVENTURE SPORTS
    • GOLF
    • ATHLETICS
    • SKIING
    • OTHER SPORTS
  • MEDIA
  • PEOPLE
  • CULTURE
    • KHYEN CHYEN
    • ARTS
    • CRAFTS
    • FESTIVALS
    • THEATER
    • LANGAUGE
  • TRAVEL
    • HOUSEBOATS
    • HOTELS
    • ANGLING
    • CAMPING
    • DESTINATION FOCUS
  • SOCIETY
    • EDUCATION
    • HEADS & TAILS
    • GENDER
    • YOUTH
    • CHILD WELFARE
  • LITERATURE
    • SHORT STORY
    • BOOKS
    • NARRATIVE
  • CINEMA
    • CINEMA & TV
  • ePAPERS
    • BAZAAR OBSERVER
    • YOUNG KASHMIR
    • MIZRAB
  • NEWSLIVE
    • TOP STORIES
    • LOCAL
    • CITY
    • REGIONAL
    • WORLD
  • IN DEPTH
    • FEATURE
    • HEADS & TAILS
    • OPINION
      • OPINION
      • EDITORIAL
      • KO ANALYSIS
      • LETTERS TO EDITOR
    • SPECIAL REPORT
    • INTERVIEW
    • REVIEW
      • BOOKS
    • LONGFORM
  • BUSINESS
    • BUSINESS NEWS
    • MARKET
    • ENERGY
    • HORTICULTURE
    • HANDICRAFTS
    • CARS & BIKES
    • STARTUP KASHMIR
  • SPORT
    • FOOTBAL
    • CRICKET
    • ADVENTURE SPORTS
    • GOLF
    • ATHLETICS
    • SKIING
    • OTHER SPORTS
  • MEDIA
  • PEOPLE
  • CULTURE
    • KHYEN CHYEN
    • ARTS
    • CRAFTS
    • FESTIVALS
    • THEATER
    • LANGAUGE
  • TRAVEL
    • HOUSEBOATS
    • HOTELS
    • ANGLING
    • CAMPING
    • DESTINATION FOCUS
  • SOCIETY
    • EDUCATION
    • HEADS & TAILS
    • GENDER
    • YOUTH
    • CHILD WELFARE
  • LITERATURE
    • SHORT STORY
    • BOOKS
    • NARRATIVE
  • CINEMA
    • CINEMA & TV
  • ePAPERS
    • BAZAAR OBSERVER
    • YOUNG KASHMIR
    • MIZRAB
No Result
View All Result
Kashmir Observer
No Result
View All Result
Home HEALTH

Covaxin Gets Emergency Use Approval For Kids Aged 2-18 Years

by Press Trust of India
October 12, 2021
A A
0
SHARES
8
VIEWS


New Delhi-
An expert panel of India’s Central drug authority has recommended granting emergency use authorisation to Bharat Biotech’s Covaxin for children and adolescents in the 2 to 18 years age group with certain conditions, sources said on Tuesday.

If approved by the Drugs Controller General of India (DCGI), it will be the second COVID-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.

ADVERTISEMENT

Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 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.

Read Also

LD Shocker! Probe Ordered Into Fake Doctors Entry Inside Labour Room

Challenge Of Opposition

“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 DCGI for final approval.

If approved by DCGI, it will be the second vaccine after Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D to receive EUA for use in those below 18 years.

Bharat Biotech 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, 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.

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, according to the recommendations.

So far, indigenously developed Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D has received EUA from the Drug Regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country, besides.

The DCGI on September 1 granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trial of its made in India COVID-19 vaccine on children and adolescents aged between 5 and 18 years with certain conditions.

The DCGI in July also granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.

 

Follow this link to join our WhatsApp group: Join Now

Be Part of Quality Journalism

Quality journalism takes a lot of time, money and hard work to produce and despite all the hardships we still do it. Our reporters and editors are working overtime in Kashmir and beyond to cover what you care about, break big stories, and expose injustices that can change lives. Today more people are reading Kashmir Observer than ever, but only a handful are paying while advertising revenues are falling fast.

ACT NOW
MONTHLYRs 100
YEARLYRs 1000
LIFETIMERs 10000

CLICK FOR DETAILS

ShareTweetSendShareShareSend
Previous Post

Firing Resumes in Poonch Encounter Site After 16 Hours

Next Post

Iraq: Sadr Claims Largest Bloc, Promises Nationalist Govt

Press Trust of India

Press Trust of India

Related Posts

LD Shocker! Probe Ordered Into Fake Doctors Entry Inside Labour Room
TOP STORIES

LD Shocker! Probe Ordered Into Fake Doctors Entry Inside Labour Room

Challenge Of Opposition
EDITORIAL

Challenge Of Opposition

Desh Bhagat University Fraud: Kashmiri Students Hail Action
TOP STORIES

Desh Bhagat University Fraud: Kashmiri Students Hail Action

PSA Detention Invalid If Representation Not Considered: J&K HC
TOP STORIES

PSA Detention Invalid If Representation Not Considered: J&K HC

Centre Grants 265 DNB Medical Seats To J&K
TOP STORIES

J&K Wins Praise From NITI Aayog For DNB Implementation

Police Officer Sheikh Adil Arrested In Srinagar
TOP STORIES

J&K Police DySP Sheikh Adil Arrested On Graft Charges

Next Post
Iraq: Sadr Claims Largest Bloc, Promises Nationalist Govt

Iraq: Sadr Claims Largest Bloc, Promises Nationalist Govt

Super League: Kashmir Maharaja Defeat J&K Forest 2-0

Super League: Kashmir Maharaja Defeat J&K Forest 2-0

Please login to join discussion

Pages

  • ABOUT US
  • ADVERTISE IN KO
  • ARCHIVE
  • BE PART OF QUALITY JOURNALISM
  • CONTACT
  • CONTRIBUTORS
  • INTERNSHIPS AT OBSERVER
  • JOBS@KO
  • KO – Homepage
  • MISSION STATEMENT
  • POLICIES
    • COMMENTING GUIDELINES
    • COOKIE POLICY
    • DISCLAIMER
    • PRIVACY POLICY
    • TERMS
  • Refund Policy
  • Team

SEARCH IN ARCHIVE

No Result
View All Result

FOLLOW US

About Us

The media in Kashmir, comprising a robust English and vernacular press has a particularly unenviable job to do. The problems faced by it are both universal to the conflict situations and unique to the region. Read More

Advertising

For Advertising on various Kashmir Observer platforms
contact

[email protected]
+91-194-2502327; +91-1947969705

© 1997 -2023 | KASHMIR OBSERVER LLP

No Result
View All Result
  • NEWS
    • TOP STORIES
    • LOCAL
    • CITY
    • REGIONAL
    • WORLD
  • IN DEPTH
    • FEATURE
    • HEADS & TAILS
    • OPINION
      • OPINION
      • EDITORIAL
      • KO ANALYSIS
      • LETTERS TO EDITOR
    • SPECIAL REPORT
    • INTERVIEW
    • REVIEW
      • BOOKS
    • LONGFORM
  • BUSINESS
    • BUSINESS NEWS
    • MARKET
    • ENERGY
    • HORTICULTURE
    • HANDICRAFTS
    • CARS & BIKES
    • STARTUP KASHMIR
  • SPORT
    • FOOTBAL
    • CRICKET
    • ADVENTURE SPORTS
    • GOLF
    • ATHLETICS
    • SKIING
    • OTHER SPORTS
  • MEDIA
  • PEOPLE
  • CULTURE
    • KHYEN CHYEN
    • ARTS
    • CRAFTS
    • FESTIVALS
    • THEATER
    • LANGAUGE
  • TRAVEL
    • HOUSEBOATS
    • HOTELS
    • ANGLING
    • CAMPING
    • DESTINATION FOCUS
  • SOCIETY
    • EDUCATION
    • HEADS & TAILS
    • GENDER
    • YOUTH
    • CHILD WELFARE
  • LITERATURE
    • SHORT STORY
    • BOOKS
    • NARRATIVE
  • CINEMA
    • CINEMA & TV
  • ePAPERS
    • BAZAAR OBSERVER
    • YOUNG KASHMIR
    • MIZRAB

© 1997 -2023 | KASHMIR OBSERVER LLP