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With Start Of COVID Vaccination Around Corner, 70-80 Per Cent Reduction In COVAXIN Trial Participation: AIIMS Doctor

Dr Sanjay Rai, Professor of Community Medicine at AIIMS said there is not as much excitement for clinical trial as over finalisation of a COVID-19 vaccine

With Start Of COVID Vaccination Around Corner, 70-80 Per Cent Reduction In COVAXIN Trial Participation: AIIMS Doctor
Highlights
  • 1,500-2,000 participants are needed in phase 3 clinical trials of COVAXIN
  • AIIMS has been able to recruit only 200 participants for phase 3 trial
  • In phase 1, 2 trials of COVAXIN, a large volunteer participation was seen

New Delhi: With the start of COVID vaccination an immediate future in India, the phase III clinical trial for indigenously-developed Bharat Biotech’s vaccine candidate COVAXIN is witnessing a shortage of volunteer participation, with a high refusal rate 70 per cent to 80 per cent, a senior AIIMS doctor said on Wednesday (December 16). “When the clinical trial began, we wanted 100 volunteers and received over 4,500 applications. In phase II, we wanted 50 and received 4,000 applications. In phase III, now when wanted 1,500-2,000 participants, we could only recruit about 200 participants as of now. It is happening because people are thinking why to volunteer when a vaccine is coming for everyone soon,” Dr Sanjay Rai, Professor of Community Medicine at AIIMS told ANI.

Also Read: Bharat Biotech’s COVID-19 Vaccine Well Tolerated With No Serious Adverse Events: Phase 1 Trial Findings

Dr Rai said there is not much excitement for clinical trial as people are over-excited about the vaccine, and added that as per the guidelines of the Central government, in the first phase, vaccines will only be administered to priority groups.

Fact is that, even if a vaccine comes, it’ll be given to healthcare providers, frontline workers, elderly with co-morbidities first. But people think they will get vaccine soon, he added.

Also Read: Quarter Of World’s Population May Not Have Access To Coronavirus Vaccine Until 2022, Study Suggests

The government’s National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) recommended that prioritised population groups will specifically be vaccinated.

The group include–approximately one crore, healthcare workers (HCWs) healthcare providers and workers in the healthcare setting; about two crore frontline Workers (FLWs)which includes personnel from state and central police, armed forces, home guards, civil defence and disaster management volunteers, municipal workers; approximately 27 crores prioritized age group population above 50 years and persons below 50 years with associated co-morbidities.

This scenario was not seen in the phase I and phase II clinical trial. There was no refusal rate at all, Dr Rai who is a principal investigator for COVAXIN clinical trial said.

Dr Rai opined that because phase III is a double-blind clinical trial, the authorities have to inform the participants that 50 per cent would receive the vaccine and other 50 per cent would receive the placebo.

Also Read: States Receive Freezers, Ice-Lined Refrigerators For COVID-19 Vaccination: Ministry Of Health

After listening to this most of the participants refuse to participate in the clinical trial saying that vaccine is coming soon. Now we are planning to create awareness among people through advertisements, email and telephone. It is important for people to participate in the clinical trial to get a safe and efficient vaccine, he stated.

The doctor added that authorities are hoping to finish the phase III clinical trial by the end of this month (December).

Meanwhile, the Centre has prepared a detailed guideline for mass COVID vaccination. The Union Health Ministry has also directed the states to prepare for adverse events post COVID-19 vaccination as can’t be ruled out.

Till the time there is no vaccine, people have to strictly follow COVID-19 appropriate behaviour by wearing a face mask, washing or sanitising hands and maintaining social distancing.

Also Read: COVID-19 Vaccination Centre Issues Guidelines For Safe Waste Disposal Of Syringes

(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

24,36,58,646Cases
20,51,42,869Active
3,35,67,367Recovered
49,48,410Deaths
Coronavirus has spread to 195 countries. The total confirmed cases worldwide are 24,36,58,646 and 49,48,410 have died; 20,51,42,869 are active cases and 3,35,67,367 have recovered as on October 25, 2021 at 4:04 am.

India

3,41,89,774 14,306Cases
1,67,6954,899Active
3,35,67,367 18,762Recovered
4,54,712 443Deaths
In India, there are 3,41,89,774 confirmed cases including 4,54,712 deaths. The number of active cases is 1,67,695 and 3,35,67,367 have recovered as on October 25, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,02,961 1,410

27,506 128

64,35,439 1,520

1,40,016 18

Kerala

49,15,331 8,538

77,964 3,191

48,08,775 11,366

28,592 363

Karnataka

29,85,986 388

8,740 203

29,39,239 586

38,007 5

Tamil Nadu

26,95,216 1,127

13,034 246

26,46,163 1,358

36,019 15

Andhra Pradesh

20,63,577 400

5,102 120

20,44,132 516

14,343 4

Uttar Pradesh

17,10,095 13

103 9

16,87,093 4

22,899

West Bengal

15,86,455 989

7,882 151

15,59,518 828

19,055 10

Delhi

14,39,603 37

320 14

14,14,192 51

25,091

Odisha

10,38,411 447

4,185 33

10,25,917 410

8,309 4

Chhattisgarh

10,05,847 20

219 11

9,92,056 31

13,572

Rajasthan

9,54,402 2

31 1

9,45,417 3

8,954

Gujarat

8,26,418 16

164 4

8,16,167 20

10,087

Madhya Pradesh

7,92,749 9

85 6

7,82,141 3

10,523

Haryana

7,71,157 16

127 12

7,60,981 4

10,049

Bihar

7,26,058 4

38 2

7,16,359 2

9,661

Telangana

6,70,274 135

3,950 34

6,62,377 168

3,947 1

Assam

6,08,589 139

3,857 111

5,98,759 244

5,973 6

Punjab

6,02,209 20

229 2

5,85,429 22

16,551

Jharkhand

3,48,627 35

224 22

3,43,268 13

5,135

Uttarakhand

3,43,821 6

163 6

3,36,259 11

7,399 1

Jammu And Kashmir

3,31,638 72

866 4

3,26,343 68

4,429

Himachal Pradesh

2,22,638 69

1,496 82

2,17,406 149

3,736 2

Goa

1,77,886 34

545 29

1,73,983 63

3,358

Puducherry

1,27,735 61

467 10

1,25,411 49

1,857 2

Manipur

1,23,292 63

931 30

1,20,450 89

1,911 4

Mizoram

1,17,419 158

8,080 863

1,08,927 1,016

412 5

Tripura

84,389 5

98 3

83,475 8

816

Meghalaya

83,371 49

639 56

81,286 102

1,446 3

Chandigarh

65,323 2

28 1

64,475 1

820

Arunachal Pradesh

55,089

132 10

54,677 10

280

Sikkim

31,900 32

200 5

31,306 27

394

Nagaland

31,712 5

243 7

30,790 12

679

Ladakh

20,904 5

37 1

20,659 6

208

Dadra And Nagar Haveli

10,679

4 0

10,671

4

Lakshadweep

10,365

0 0

10,314

51

Andaman And Nicobar Islands

7,648

6 2

7,513 2

129

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