Connect with us

Coronavirus Vaccine

Expert Panel Recommends COVID Vaccine Covaxin In 2-18 Age Group

Bharat Biotech had completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 and 18 years and the data was submitted to the Central Drugs Standard Control Organisation (CDSCO)

Expert Panel Recommends COVID Vaccine Covaxin In 2-18 Age Group
Highlights
  • The Subject Expert Committee on COVID-19 examined phase2/3 data of Covaxin
  • The committee has recommended emergency use authorisation for 2-18-year-old
  • Drugs Controller General of India will take the final call on EUA

New Delhi: 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 (October 12). 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 (October 11).

Also Read: First Covid Vaccine For Children Above 12 Approved In India

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.

Also Read: Zydus Cadila’s COVID Vaccine To Be Inoculated Through An Applicator: Dr VK Paul

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol have been working towards a clean and healthy India since 2014 via Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ populationindigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (WaterSanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity,  that is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and the country can become a Swasth or healthy India. 

World

26,27,61,966Cases
22,35,18,265Active
3,40,28,506Recovered
52,15,195Deaths
Coronavirus has spread to 196 countries. The total confirmed cases worldwide are 26,27,61,966 and 52,15,195 have died; 22,35,18,265 are active cases and 3,40,28,506 have recovered as on December 1, 2021 at 3:56 am.

India

3,45,96,776 8,954Cases
99,0231,520Active
3,40,28,506 10,207Recovered
4,69,247 267Deaths
In India, there are 3,45,96,776 confirmed cases including 4,69,247 deaths. The number of active cases is 99,023 and 3,40,28,506 have recovered as on December 1, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,35,658 678

11,226 299

64,83,435 942

1,40,997 35

Kerala

51,41,814 4,723

44,314 824

50,57,368 5,370

40,132 177

Karnataka

29,96,148 291

6,445 462

29,51,492 745

38,211 8

Tamil Nadu

27,26,917 720

8,244 47

26,82,192 758

36,481 9

Andhra Pradesh

20,72,909 184

2,149 47

20,56,318 134

14,442 3

Uttar Pradesh

17,10,399 12

89 3

16,87,399 8

22,911 1

West Bengal

16,16,083 705

7,731 2

15,88,866 694

19,486 13

Delhi

14,40,934 34

287 2

14,15,549 32

25,098

Odisha

10,49,108 228

2,188 23

10,38,509 203

8,411 2

Chhattisgarh

10,06,813 34

318 0

9,92,902 34

13,593

Rajasthan

9,54,785 15

193 6

9,45,637 9

8,955

Gujarat

8,27,475 40

275 13

8,17,108 27

10,092

Madhya Pradesh

7,93,170 20

119 7

7,82,523 27

10,528

Haryana

7,71,709 17

163 2

7,61,492 19

10,054

Bihar

7,26,223 4

36 3

7,16,524 7

9,663

Telangana

6,75,994 196

3,591 10

6,68,411 184

3,992 2

Assam

6,16,852 144

2,625 30

6,08,124 109

6,103 5

Punjab

6,03,279 21

325 4

5,86,352 22

16,602 3

Jharkhand

3,49,244 12

98 3

3,44,006 9

5,140

Uttarakhand

3,44,255 28

141 9

3,36,706 19

7,408

Jammu And Kashmir

3,36,852 171

1,625 1

3,30,751 172

4,476

Himachal Pradesh

2,27,195 102

834 10

2,22,513 91

3,848 1

Goa

1,78,928 38

284 8

1,75,260 30

3,384

Mizoram

1,35,175 365

3,751 54

1,30,927 415

497 4

Puducherry

1,28,924 31

284 12

1,26,768 43

1,872

Manipur

1,25,205 36

649 6

1,22,579 40

1,977 2

Tripura

84,805 14

81 3

83,900 10

824 1

Meghalaya

84,480 19

294 9

82,713 9

1,473 1

Chandigarh

65,465 9

65 7

64,580 2

820

Arunachal Pradesh

55,276 3

35 0

54,961 3

280

Sikkim

32,242 9

124 3

31,715 6

403

Nagaland

32,122 13

133 7

31,293 20

696

Ladakh

21,578 38

276 26

21,088 12

214

Dadra And Nagar Haveli

10,683

1 0

10,678

4

Lakshadweep

10,394

24 0

10,319

51

Andaman And Nicobar Islands

7,683

6 2

7,548 2

129

Coronavirus Outbreak: Full CoverageTesting CentresFAQs

Highlights From The 12-Hour Telethon

Leaving No One Behind

Mental Health

Environment

Join Us