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Serum Institute To Resume COVID-19 Vaccine Trials In India After Nod From Drugs Controller General Of India

According to Adar Poonawalla, CEO and Owner, Serum Institute of India, conclusions should not be drawn until the trials of the Oxford University’s COVID-19 vaccine are fully concluded so that the process of vaccine development remains unbiased

Serum Institute To Resume COVID-19 Vaccine Trials In India After Nod From Drugs Controller General Of India

New Delhi: Hours after clinical trials for AstraZeneca and Oxford University coronavirus vaccine resumed on Saturday in the UK, pharma major Serum Institute of India (SII) said it will resume the trials in India once Drugs Controller General of India (DCGI) gives it requisite permission. AstraZeneca PLC had on September 6 paused the trial of coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was also reported that the clinical trials had been put on hold in other countries including USA, UK, Brazil and South Africa.

Also Read: AstraZeneca Vaccine Trial Pause A ‘Wake-Up Call’, Says WHO

Following the developments, India’s top drugs regulator had asked SII to suspend any new recruitment in phase two and three clinical trials for COVID-9 vaccine till further orders.

The DCGI directed the pharma company to increase safety monitoring of the subjects already vaccinated with the candidate vaccine and submit its plan and report.

SII now has to submit clearance from Data and Safety Monitoring Board (DSMB), UK and DSMB India to obtain clearance from DCGI’s office before it can resume trials, officials said.

Once DCGI will give us the permission to restart the trials in India, we will resume the trials, Serum Institute of India said in its statement.

According to the reports on Saturday, clinical trials for AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

Also Read: Serum Institute To Produce COVID-19 Vaccine Candidate Developed By Oxford University, Will Be Called Covishield In India

The company said that that the “standard review process triggered a voluntary pause” to all global trials on September 6 so that independent committees and internal regulators could review the safety data.

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic, Astra Zeneca said in a statement.

Adar Poonawalla, CEO and Owner, Serum Institute of India, said no conclusions should be drawn till the trials are completed.

As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chains of events are a clear example why we should not bias the process and should respect the process till the end. Good news, UniofOxford, he said in a tweet.

India’s top drugs regulator granted permission to SII on August 2 to conduct phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

The vaccine will be manufactured by Serum Institute in India under technical collaboration with Oxford University and AstraZeneca which have developed the candidate vaccine.

Also Read: DCGI Gives Nod To Serum Institute To Hold Phase II, III COVID Vaccine Trials

(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

22,70,55,138Cases
18,97,86,461Active
3,25,98,424Recovered
46,70,253Deaths
Coronavirus has spread to 195 countries. The total confirmed cases worldwide are 22,70,55,138 and 46,70,253 have died; 18,97,86,461 are active cases and 3,25,98,424 have recovered as on September 17, 2021 at 5:36 am.

India

3,33,81,728 34,403Cases
3,39,0563,867Active
3,25,98,424 37,950Recovered
4,44,248 320Deaths
In India, there are 3,33,81,728 confirmed cases including 4,44,248 deaths. The number of active cases is 3,39,056 and 3,25,98,424 have recovered as on September 17, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

65,11,525 3,595

52,893 310

63,20,310 3,240

1,38,322 45

Kerala

44,46,228 22,182

1,86,754 4,559

42,36,309 26,563

23,165 178

Karnataka

29,65,191 1,108

16,202 282

29,11,434 808

37,555 18

Tamil Nadu

26,40,361 1,693

16,756 120

25,88,334 1,548

35,271 25

Andhra Pradesh

20,34,786 1,367

14,708 105

20,06,034 1,248

14,044 14

Uttar Pradesh

17,09,628 23

193 11

16,86,549 11

22,886 1

West Bengal

15,59,567 707

8,025 25

15,32,922 725

18,620 7

Delhi

14,38,373 28

409 5

14,12,880 22

25,084 1

Odisha

10,18,298 580

5,335 105

10,04,845 681

8,118 4

Chhattisgarh

10,04,988 31

352 2

9,91,077 29

13,559

Rajasthan

9,54,230 4

103 1

9,45,173 5

8,954

Gujarat

8,25,677 22

149 0

8,15,446 22

10,082

Madhya Pradesh

7,92,374 7

119 5

7,81,738 12

10,517

Haryana

7,70,697 9

327 8

7,60,562 17

9,808

Bihar

7,25,864 12

72 6

7,16,134 6

9,658

Telangana

6,62,785 259

5,282 43

6,53,603 301

3,900 1

Punjab

6,01,180 30

314 11

5,84,399 38

16,467 3

Assam

5,97,074 468

5,381 15

5,85,914 479

5,779 4

Jharkhand

3,48,102 6

102 8

3,42,867 14

5,133

Uttarakhand

3,43,330 20

284 12

3,35,657 32

7,389

Jammu And Kashmir

3,27,466 170

1,421 72

3,21,630 98

4,415

Himachal Pradesh

2,16,430 127

1,568 82

2,11,215 206

3,647 3

Goa

1,75,183 95

699 1

1,71,195 96

3,289

Puducherry

1,25,170 107

963 63

1,22,380 42

1,827 2

Manipur

1,17,913 216

2,614 7

1,13,478 219

1,821 4

Tripura

83,787 31

427 26

82,553 56

807 1

Meghalaya

78,958 229

1,804 140

75,784 86

1,370 3

Mizoram

76,591 1,121

13,888 85

62,449 1,202

254 4

Chandigarh

65,168 4

31 2

64,319 2

818

Arunachal Pradesh

53,990 47

536 9

53,183 56

271

Sikkim

30,802 64

775 28

29,648 36

379

Nagaland

30,763 32

505 14

29,610 44

648 2

Ladakh

20,631 6

41 1

20,383 5

207

Dadra And Nagar Haveli

10,670

5 0

10,661

4

Lakshadweep

10,353

4 0

10,298

51

Andaman And Nicobar Islands

7,595 3

15 2

7,451 1

129

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