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Bharat Biotech Seeks Emergency Use Authorisation For Indigenously Developed COVID-19 Vaccine Covaxin

Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and is currently in Phase 3 trials

Bharat Biotech Seeks Emergency Use Authorisation For Indigenously Developed COVID-19 Vaccine Covaxin
Highlights
  • Final approval is granted after completion of trials, analysis of full data
  • Phase-3 trial of Covaxin is going on in around 25 places in India
  • SII sought the nod for Oxford COVID-19 vaccine, Covishield, on December 6

New Delhi: After Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, official sources said. Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The Hyderabad-based firm is conducting phase-3 clinical trial of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow. The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.

Also Read: Department Of Biotechnology’s Expert Committee Tracking Developments Related To COVID-19 Vaccine: Official

The most common adverse event was transient pain at the injection site, a source said. The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials.

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India (SII) and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9, a source said.

Also Read: Serum Institute Likely To Supply COVID Vaccine At Rs. 250 Per Dose: Report

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

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. 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 highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. 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 become a Swasth or healthy India. The campaign will continue to cover issues like air pollutionwaste managementplastic banmanual scavenging and sanitation workers and menstrual hygiene

World

26,43,68,460Cases
22,50,84,762Active
3,40,45,666Recovered
52,38,032Deaths
Coronavirus has spread to 196 countries. The total confirmed cases worldwide are 26,43,68,460 and 52,38,032 have died; 22,50,84,762 are active cases and 3,40,45,666 have recovered as on December 3, 2021 at 1:36 pm.

India

3,46,15,757 9,216Cases
99,976 213Active
3,40,45,666 8,612Recovered
4,70,115 391Deaths
In India, there are 3,46,15,757 confirmed cases including 4,70,115 deaths. The number of active cases is 99,976 and 3,40,45,666 have recovered as on December 3, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,37,221 796

10,882 180

64,85,290 952

1,41,049 24

Kerala

51,51,919 4,700

45,030 252

50,66,034 4,128

40,855 320

Karnataka

29,96,833 363

6,772 169

29,51,845 191

38,216 3

Tamil Nadu

27,28,350 715

8,155 45

26,83,691 748

36,504 12

Andhra Pradesh

20,73,252 159

2,138 11

20,56,670 169

14,444 1

Uttar Pradesh

17,10,417 12

93 1

16,87,413 11

22,911

West Bengal

16,17,408 657

7,690 22

15,90,208 667

19,510 12

Delhi

14,41,190 217

307 21

14,15,785 196

25,098

Odisha

10,49,597 252

2,211 26

10,38,971 276

8,415 2

Chhattisgarh

10,06,870 37

328 12

9,92,949 25

13,593

Rajasthan

9,54,827 21

213 10

9,45,659 11

8,955

Gujarat

8,27,570 50

318 25

8,17,158 24

10,094 1

Madhya Pradesh

7,93,199 12

128 4

7,82,543 8

10,528

Haryana

7,71,760 27

178 9

7,61,528 18

10,054

Bihar

7,26,230 5

32 0

7,16,534 4

9,664 1

Telangana

6,76,376 189

3,680 50

6,68,701 137

3,995 2

Assam

6,17,163 124

2,535 77

6,08,517 198

6,111 3

Punjab

6,03,352 32

344 13

5,86,402 18

16,606 1

Jharkhand

3,49,271 15

95 1

3,44,035 13

5,141 1

Uttarakhand

3,44,325 22

182 4

3,36,735 18

7,408

Jammu And Kashmir

3,37,263 177

1,697 10

3,31,089 167

4,477

Himachal Pradesh

2,27,354 85

835 29

2,22,669 113

3,850 1

Goa

1,79,046 56

367 40

1,75,295 16

3,384

Mizoram

1,35,765 315

3,717 55

1,31,545 368

503 2

Puducherry

1,28,998 33

299 10

1,26,826 23

1,873

Manipur

1,25,269 33

663 4

1,22,627 28

1,979 1

Tripura

84,835 15

94 6

83,916 8

825 1

Meghalaya

84,534 24

296 2

82,764 25

1,474 1

Chandigarh

65,475 4

65 1

64,590 5

820

Arunachal Pradesh

55,285 6

36 1

54,969 5

280

Sikkim

32,267 15

137 10

31,727 5

403

Nagaland

32,128 3

128 5

31,302 6

698 2

Ladakh

21,642 41

306 21

21,122 20

214

Dadra And Nagar Haveli

10,683

0 1

10,679 1

4

Lakshadweep

10,397 1

18 8

10,328 9

51

Andaman And Nicobar Islands

7,686 3

7 2

7,550 1

129

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