Interim Phase 3 Results Of COVID-19 Vaccine Covaxin ‘Encouraging’, More Data Needed: AIIMS Director

Interim Phase 3 Results Of COVID-19 Vaccine Covaxin ‘Encouraging’, More Data Needed: AIIMS Director

Covaxin is one of the two COVID-19 vaccines to have got emergency use license in India and is being used in India’s vaccination programme
Interim Phase 3 Results Of COVID-19 Vaccine Covaxin ‘Encouraging’, More Data Needed: AIIMS DirectorCovaxin is a COVID-19 vaccine developed by Bharat Biotech International Limited (BBIL) in partnership with the Indian Council of Medical Research (ICMR)
Highlights
  • Phase 3 trial of Covaxin was started in mid-November, 2020 across 25 sites
  • Clinical trial of Covaxin involves 25,800 participants aged between 18-98
  • Interim efficacy data is based on 43 participants who got COVID-19

New Delhi: Phase 3 results of the indigenous COVID-19 vaccine Covaxin, developed by Bharat Biotech International Limited (BBIL) in partnership with Indian Council of Medical Research (ICMR), has shown an interim vaccine efficacy of 81 per cent in preventing COVID-19, revealed Bharat Biotech on March 3. The phase 3 trial was initiated in mid-November 2020, covering a total of 25,800 individuals across 25 sites. Covaxin is one of the two COVID-19 vaccines to have got emergency use license in India. Covaxin was cleared by the Drug Controller General of India (DCGI) in early January on the basis of Phase I and II data that confirmed its safety and immunogenicity. NDTV spoke to AIIMS Director Dr Randeep Guleria, who himself has got both the doses of Covaxin, to understand the interim analysis better.

Also Read: COVID-19 Vaccines And Dosage: WHO’s Soumya Swaminathan Answers FAQs On Vaccines

Dr Guleria called the interim data encouraging but said the trials will continue as more data is needed for final analysis. He explained,

We already had data from phase 1 and phase 2 which showed good neutralising antibodies and there was also enough data to suggest safety but one wanted to look at the efficacy data. However, one should keep in mind that this is the interim result because they need to have 130-140 odd COVID positive cases to analyse the data. This is the interim result of 43 subjects who got COVID and they looked at how many of them were in the placebo arm (people who are not given vaccine) as compared to those in the vaccine arm.

Also Read: ‘Let Us Make India COVID-19 Free’, Says PM Modi After Taking First Shot Of Coronavirus Vaccine

Covaxin’s Phase III trials, which began in November last year, involved 25,800 participants aged between 18 and 98 across 25 sites. Over 2,000 participants (2,433) were over 60-year-old and 4,533 participants had co-morbidities. The trial is being called the largest clinical trial ever conducted in India. Elaborating on the need for additional data, Dr Guleria said,

In terms of people who are enrolled in the trial, this is the largest trial conducted in the country on Indian subjects. But really to see the efficacy, you want to have a sufficient number of people who get infected with COVID-19 and then you don’t know which group has got the vaccine and which has got the placebo. When you have a sufficient number of people who have got infected which can give you a statistically significant number which is calculated before the trial was done and the sample size was calculated then you can say that yes, this is the efficacy which is based on a good number which is significant and currently the data is interim.

Also Read: Who All Above The Age Of 45 Are Eligible For COVID-19 Vaccine? Here’s All You Need To Know

Dr Guleria explained that after 43 individuals from over 25,000 participants got COVID-19, the code was broken to see who got the vaccine and who got the placebo.

In the placebo arm, there were 36 people who got the COVID-19 infection, whereas, in the vaccine arm there were only 7. Based on that, the calculation showed that the vaccine efficacy is around 81 per cent. But we will need to have around 130 people who get the infection and then we again break the code and see how many of them are in the vaccine arm and how many are in the placebo arm to get real efficacy data, but the interim result is very encouraging and I think that should be a big boost to the vaccination programme in our country.

Dr Guleria confirmed that phase 3 trials will continue as the final analysis is planned for 130 cases. An interim analysis is done to ensure you are going in the right direction and the vaccine is effective, he added.

Dr Guleria also suggested vaccine developers to put the interim data in the public domain and get it peer-reviewed. He said,

Everyone can look at it critically both in terms of what was the protection, how much did it (vaccine) protect from a severe infection, did it give some protection even from mild infection or not getting the infection at all and what was the morality benefit that it had. There are a lot of secondary endpoints which can also be looked at as far as data is concerned.

Also Read: COVID-19: WHO Chief Scientist Says India Exhibited Capacity To Innovate, Manufacture Vaccines

Dr Guleria noted that another positive thing about Covaxin trials is that it covers the elderly and people with comorbidities. He said,

Many of the vaccines which were initially out excluded those with comorbidities and the elderly age group because they were not sure about the safety and they wanted to see efficacy in a group where the immune response would be robust enough. Again, this is something which is very encouraging and as we get more data out, it will also be useful to see what was the protection in those over the age of 60, in those who had comorbidities and was it the same as compared to those who are less than 60 or in the younger age group and those who do not have comorbidities.

Going forward, Dr Guleria recommends focusing on two things – firstly, eliminating vaccine hesitancy and reassuring citizens that the data is encouraging and they should get vaccinated; secondly, continue the trials to see the final efficacy which may go up as more and more people get the infection.

The interim result is very encouraging and I think it should put all sorts of doubts at rest and we should really look forward in terms of promoting this vaccine also in a big way as far as our national vaccine programme is concerned. We need to vaccinate a large number of people in our country to be able to prevent the pandemic from progressing further, said Dr Guleria.

Also Read: COVID-19 Explained: Here’s How You Can Register For The COVID-19 Vaccine On The Co-WIN Portal

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

14,20,88,128Cases
5,77,81,440Active
8,12,77,323Recovered
30,29,365Deaths
Coronavirus has spread to 192 countries. The total confirmed cases worldwide are 14,20,88,128 and 30,29,365 have died; 5,77,81,440 are active cases and 8,12,77,323 have recovered as on April 20, 2021 at 3:53 am.

India

1,53,21,089 259170Cases
20,31,977 102648Active
1,31,08,582 154761Recovered
1,80,530 1761Deaths
In India, there are 1,53,21,089 confirmed cases including 1,80,530 deaths. The number of active cases is 20,31,977 and 1,31,08,582 have recovered as on April 20, 2021 at 2:30 am.

State & District Details

State Cases Active Recovered Deaths
DistrictCases
Mumbai45,478
Thane13,660
Pune9,920
Mumbai Suburban5,363
Aurangabad1,974
Nashik1,575
Raigad1,462
Palghar1,421
Solapur1,291
Jalgaon1,039
Akola757
Nagpur692
Kolhapur646
Satara629
Ratnagiri350
Amravati291
Dhule228
Hingoli208
Jalna201
Ahmednagar190
Nanded176
Yavatmal150
Sangli145
Latur139
Osmanabad125
Sindhudurg114
Buldhana88
Parbhani78
gondia69
Beed54
Nandurbar42
Gadchiroli42
Bhandara41
Chandrapur32
Washim13
Wardha11

38,98,262 58,924

6,78,198 6,161

31,59,240 52,412

60,824 351

DistrictCases
Kannur357
Kasaragod333
Palakkad224
Malappuram119
Kollam118
Thrissur106
Thiruvananthapuram104
Pathanamthitta98
Kozhikode90
Alappuzha76
Kottayam73
Ernakulam60
Idukki40
Wayanad36

12,53,068 13,644

1,03,327 9,318

11,44,791 4,305

4,950 21

DistrictCases
Udupi1,176
Kalaburagi669
Yadgir538
Bengaluru Urban529
Raichur369
Mandya346
Belagavi337
Bidar219
Hassan205
Davangere204
Vijayapura201
Dakshina Kannada179
Chikkaballapura149
Mysuru107
Bagalkote103
Uttara Kannada95
Shivamogga67
Dharwad61
Ballari60
Gadag45
Bengaluru Rural40
Tumakuru36
Kolar29
Haveri24
Chikkamagaluru19
Chitradurga14
Koppal5
Kodagu4
Ramanagara3
Chamarajanagara0

11,76,850 15,785

1,42,103 8,541

10,21,250 7,098

13,497 146

DistrictCases
Chennai23,324
Chengalpattu1,314
Thiruvallur774
Villupuram509
Kanchipuram503
Tiruvannamalai496
Cuddalore477
Ariyalur444
Tirunelveli433
Tuticorin333
Kallakurichi324
Madurai322
Salem258
Coimbatore188
Virudhunagar185
Dindigul175
Perambalur133
Ranipet133
Thanjavur130
Theni129
Tiruchirappalli119
Ramanathapuram119
Tiruppur116
Kanniyakumari110
Tenkasi103
Nagapattinam99
Karur88
Namakkal83
Erode75
Vellore71
Thiruvarur67
Pudukkottai53
Sivaganga46
Tirupathur45
Krishnagiri43
The Nilgiris17
Dharmapuri15

10,02,392 10,941

75,116 4,725

9,14,119 6,172

13,157 44

DistrictCases
Kurnool795
Krishna557
Guntur511
Anantapur428
East Godavari356
Chittoor319
Sri Potti Sriramulu Nell*296
Y.S.R.205
West Godavari199
Srikakulam183
Prakasam104
Visakhapatnam103
Vizianagaram23

9,68,000 5,963

48,053 3,367

9,12,510 2,569

7,437 27

DistrictCases
Gautam Buddha Nagar1,119
Agra933
Ghaziabad794
Meerut504
Lucknow386
Saharanpur298
Kanpur Nagar286
Moradabad252
Varanasi243
Hapur225
Aligarh215
Basti214
Amethi206
Rampur203
Jaunpur194
Firozabad190
Barabanki168
Gorakhpur166
Bulandshahr166
Siddharth Nagar159
Ghazipur159
Bijnor157
Deoria143
Azamgarh138
Sant Kabeer Nagar132
Mathura129
Ayodhya120
Muzaffarnagar117
Sambhal116
Sultanpur97
Ambedkar Nagar92
Maharajganj85
Amroha80
Rae Bareli78
Bahraich73
Kheri72
Kannauj69
Baghpat68
Kushi Nagar67
Bhadohi60
Ballia60
Gonda59
Etah52
Hardoi49
Balrampur49
Mau48
Mainpuri46
Etawah46
Hathras43
Unnao42
Jalaun41
Jhansi41
Shamli40
Chandauli38
Auraiya37
Farrukhabad36
Sitapur32
Prayagraj30
Banda27
Shahjahanpur25
Shravasti23
Budaun23
Mirzapur22
Bareilly17
Kasganj16
Pratapgarh15
Pilibhit15
Sonbhadra10
Kaushambi6
Kanpur Dehat4
Chitrakoot4
Lalitpur3
Hamirpur3
Mahoba3
Fatehpur3

8,79,831 28,211

2,08,523 17,066

6,61,311 10,978

9,997 167

DistrictCases
North West5,463
Central4,817
West4,768
New Delhi3,405
North3,059
East2,472
South East2,446
South West2,391
South2,329
North East1,914
Shahdara1,580

8,77,146 23,686

76,887 1,946

7,87,898 21,500

12,361 240

DistrictCases
Kolkata2,777
Howrah1,435
24 Paraganas North1,031
Hooghly604
24 Paraganas South281
Maldah235
Dinajpur Uttar216
Coochbehar210
Birbhum206
Medinipur West159
Medinipur East153
Nadia139
Purba Bardhaman130
Murshidabad125
Bankura116
Darjeeling97
Jalpaiguri88
Paschim Bardhaman70
Purulia66
Dinajpur Dakshin50
Alipurduar39
Kalimpong18
Jhargram9

6,68,353 8,426

53,418 3,780

6,04,329 4,608

10,606 38

DistrictCases
Bilaspur100
Korba100
Mungeli87
Baloda Bazar85
Jashpur77
Janjgir-Champa56
Mahasamund54
Rajnandgaon52
Kabirdham52
Raigarh47
Raipur46
Balod41
Korea39
Durg31
Bemetara21
Kanker19
Balrampur17
Surguja14
Gariyaband10
Surajpur9
Dhamtari6
Bijapur2
Bastar2
Dantewada0
Kondagaon0
Narayanpur0
Sukma0

5,58,674 13,834

1,29,000 981

4,23,591 12,678

6,083 175

DistrictCases
Jaipur2,177
Jodhpur1,748
Udaipur724
Bharatpur563
Kota503
Nagaur500
Ajmer379
Dungarpur374
Pali352
Jhalawar329
Bhilwara250
Sikar231
Chittorgarh188
Tonk171
Jalore164
Rajsamand140
Sirohi130
Bikaner112
Banswara91
Alwar90
Churu81
Jhunjhunu64
Dausa61
Dholpur60
Baran59
Jaisalmer53
Barmer34
Hanumangarh31
SawaiMadhopur26
Karauli17
Pratapgarh14
Ganganagar8
Bundi5

4,26,584 11,967

76,641 9,506

3,46,739 2,408

3,204 53

DistrictCases
Indore3,839
Bhopal1,880
Ujjain799
Burhanpur351
Neemuch319
Jabalpur276
East Nimar266
Sagar228
Gwalior211
Khargone196
Dewas140
Dhar132
Mandsaur112
Morena109
Bhind87
Raisen71
Barwani60
Ratlam51
Rewa39
Shajapur39
Hoshangabad37
Vidisha37
Chhatarpur35
Betul35
Rajgarh31
Dindori29
Sheopur26
Damoh26
Satna24
Anuppur22
Panna20
Tikamgarh18
Sidhi17
Narsinghpur17
Chhindwara16
Agar Malwa15
Mandla15
Shivpuri15
Jhabua14
Shandol14
Singrauli13
Ashoknagar13
Datia12
Sehore12
Umaria10
Balaghat9
Guna8
Harda4
Alirajpur3
Katni3
Seoni2
Niwari0

4,20,977 12,897

74,558 5,982

3,41,783 6,836

4,636 79

DistrictCases
Ahmadabad17,125
Surat2,311
Vadodara1,555
Gandhinagar410
Mahesana159
Banas Kantha147
Bhavnagar146
Rajkot135
Arvalli134
Mahisagar125
Anand107
PanchMahals107
Patan105
SabarKantha101
Kachchh99
Kheda98
Jamnagar63
Bharuch56
Botad55
Surendranagar55
Valsad47
GirSomnath45
Dohad43
Chhotaudepur37
Naysari35
Junagadh31
Narmada25
DevbhumiDwarka22
Amreli16
Porbandar11
Tapi6
Dang5
Morbi4

4,15,972 11,403

68,754 7,107

3,41,724 4,179

5,494 117

DistrictCases
Ganjam581
Jajapur322
Khordha238
Baleshwar190
Kendrapara164
Cuttack155
Bhadrak137
Balangir129
Puri103
Sundargarh102
Jagatsinghapur91
Nayagarh86
Mayurbhanj73
Nuapada69
Gajapati61
Dhenkanal36
Boudh34
Kendujhar34
Deogarh33
Kalahandi33
Sonepur29
Kandhamal28
Anugul26
Malkangiri20
Bargarh16
Koraput16
Sambalpur16
Jharsuguda8
Nabarangpur2
Rayagada2

3,72,703 4,445

23,118 2,938

3,47,637 1,503

1,948 4

DistrictCases
Gurugram2,950
Faridabad867
Sonipat404
Rohtak145
Palwal120
Jhajjar114
Karnal104
Hisar98
Ambala93
Panipat78
Nuh68
Bhiwani60
Rewari56
Kurukshetra55
Sirsa50
Kaithal48
Mahendragarh47
CharkiDadri43
Panchkula39
Fatehabad38
Jind38
Yamunanagar19

3,63,813 6,842

45,363 3,146

3,15,002 3,663

3,448 33

DistrictCases
Hyderabad2,475
Ranga Reddy183
Suryapet87
Jagitial77
Nizamabad76
MedchalMalkajgiri75
Mancherial43
YadadriBhuvanagiri40
Jogulamba Gadwal40
Vikarabad40
Nalgonda33
Warangal Urban32
Mahabubnagar30
Sangareddy26
Khammam26
Adilabad22
Nirmal21
Karimnagar17
RajannaSircilla16
Medak11
Kamareddy11
Mahabubabad10
Jayashankar Bhupalapally9
Nagarkurnool8
Kumuram Bheem Asifabad8
Jangoan8
Siddipet7
Peddapalli5
Bhadradri Kothagudem5
Warangal Rural4
Mulugu3
Narayanpet3
Wanaparthy1

3,61,359 5,926

42,853 3,699

3,16,650 2,209

1,856 18

DistrictCases
Patna279
Bhagalpur266
Rohtas256
Khagaria253
Begusarai243
Madhubani199
Munger188
Jehanabad178
Katihar175
Darbhanga143
Samastipur139
Siwan139
PurbiChamparan138
Purnia135
Banka134
Buxar134
Nalanda123
Gopalganj123
Nawada122
Sheikhpura118
Gaya115
Kaimur (bhabua)105
Bhojpur103
Saran101
Muzaffarpur96
Saharsa88
Supaul87
Vaishali87
Madhepura82
Kishanganj75
Aurangabad75
Sitamarhi73
Lakhisarai72
Araria68
Pashchim Champaran57
Arwal52
Jamui47
Sheohar20

3,31,604 7,487

49,528 4,827

2,80,286 2,619

1,790 41

DistrictCases
Amritsar485
Jalandhar297
Ludhiana293
Tarn Taran163
Gurdaspur154
Hoshiarpur140
S.A.S Nagar137
Patiala132
Sangrur107
Shahid Bhagat Singh Nagar (Nawanshahr)99
Pathankot86
Rupnagar (Ropar)74
Faridkot74
Sri Muktsar Sahib71
Moga65
Bathinda60
Fatehgarh Sahib57
Fazilka53
Firozepur50
Kapurthala44
Mansa31
Barnala25

3,04,660 4,622

35,311 1,121

2,61,364 3,418

7,985 83

DistrictCases
Kamrup Metro276
Golaghat203
Nagaon143
Hojai89
Dima Hasao86
Karimganj85
Tinsukia84
Cachar80
Dibrugarh61
Hailakandi57
Lakhimpur57
Marigaon50
Dhemaji47
Kamrup42
Kokrajhar37
Dhubri30
Charaideo29
Barpeta28
Udalguri28
Sonitpur27
Jorhat24
Nalbari23
Darrang20
Sivasagar20
Goalpara19
Biswanath16
Baksa14
KarbiAnglong13
Bongaigaon12
Chirang6
West KarbiAnglong5
South SalmaraMancachar4
Majuli2

2,25,822 1,367

7,663 1,048

2,17,017 312

1,142 7

DistrictCases
East Singhbum170
Ranchi148
Hazaribagh110
Garhwa80
Ramgarh75
Koderma58
Simdega48
Dhanbad32
Gumla28
Palamu27
West Singhbhum21
SaraikelaKharsawan20
Giridih19
Bokaro16
Latehar14
Khunti10
Lohardaga8
Deoghar5
Dumka5
Pakur4
Jamtara2
Godda2
Chatra1
Sahebganj0

1,67,235 4,290

30,477 2,467

1,35,256 1,777

1,502 46

DistrictCases
Anantnag395
Srinagar300
Kulgam295
Baramulla271
Shopian255
Kupwara231
Bandipora175
Udhampur155
Ramban151
Jammu138
Budgam110
Pulwama108
Kathua53
Rajouri39
Ganderbal37
Poonch35
Doda27
Reasi26
Samba25
Kishtwar10
Mirpur0
Muzaffarabad0

1,48,208 1,516

12,164 697

1,33,981 813

2,063 6

DistrictCases
Dehradun370
Nainital323
Tehri Garhwal110
Haridwar94
Udam Singh Nagar83
Almora71
Champawat45
Pithoragarh43
Chamoli36
PauriGarhwal36
Bageshwar31
Rudraprayag30
Uttar Kashi24

1,26,193 2,160

18,864 1,571

1,05,437 565

1,892 24

DistrictCases
Hamirpur117
Kangra105
Una41
Solan32
Chamba29
Bilaspur21
Mandi21
Sirmaur11
Shimla10
Kullu4
Kinnaur2
Lahaul And Spiti0

78,070 1,695

9,783 1,087

67,084 595

1,203 13

DistrictCases
South Goa69
North Goa57

68,152 940

7,547 495

59,705 428

900 17

DistrictCases
Pondicherry111
Mahe4
Karaikal2
Yanam0

48,336 565

4,692 224

42,931 336

713 5

DistrictCases
Chandigarh313

34,546 612

3,804 179

30,325 429

417 4

DistrictCases
Dhalai196
Sepahijala174
Gomati74
South Tripura53
Unakoti49
West Tripura45
Khowai24
North Tripura14

34,094 60

506 44

33,194 16

394

DistrictCases
Churachandpur32
Kangpokpi26
Imphal West21
Thoubal18
Imphal East10
Tengnoupal9
Bishnupur7
Senapati6
Chandel5
Kamjong5
Ukhrul4
Jiribam3
Pherzawl3
Kakching2
Tamenglong2
Noney1

29,775 54

296 41

29,102 12

377 1

DistrictCases
Changlang31
Papum Pare8
Lohit3
Namsai2
West Siang1
East Siang1
Upper Siang1
Tawang1
PakkeKessang1
West Kameng0
Upper Subansiri0
Tirap0
Siang0
Shi Yomi0
Anjaw0
Lower Subansiri0
Lower Dibang Valley0
Longding0
Leparada0
KurungKumey0
KraDaadi0
Kamle0
East Kameng0
Dibang Valley0
Lower Siang0

17,052 65

176 54

16,820 11

56

DistrictCases
East Khasi Hills22
West Garo Hills5
South West Garo Hills4
North Garo Hills1
West Jaintia Hills1
West Khasi Hills1
East Garo Hills0
East Jaintia Hills0
Ribhoi0
South Garo Hills0
South West Khasi Hills0

14,979 108

754 74

14,071 33

154 1

DistrictCases
Dimapur20
Mon8
Kohima7
Kiphire3
Tuensang3
Peren2
Phek1
Longleng0
Mokokchung0
Wokha0
Zunheboto0

12,568 13

189 13

12,285

94

DistrictCases
Kargil77
LehLadakh43

12,306 175

1,699 52

10,474 123

133

DistrictCases
East District3
South District3
North District0
West District0

6,705 9

404 5

6,165 4

136

DistrictCases
South Andamans33
Nicobars1
North And Middle Andaman1

5,421 31

145 19

5,212 12

64

DistrictCases
Dadra And Nagar Haveli20

5,102 299

1,136 213

3,962 86

4

DistrictCases
Kolasib11
Aizawl10
Mamit8
Lawngtlai2
Lunglei2
Saitual1
Champhai0
Hnahthial0
Khawzawl0
Saiha0
Serchhip0

4,995 91

437 54

4,546 37

12

DistrictCases
Lakshadweep District0

1,282 117

490 100

791 17

1

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