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

March 5, 2021 0 Comments



Covaxin 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

11,56,01,068Cases

4,76,65,788Active

6,53,67,084Recovered

25,68,196Deaths

Coronavirus has spread to 192 countries. The total confirmed cases worldwide are 11,56,01,068 and 25,68,196 have died; 4,76,65,788 are active cases and 6,53,67,084 have recovered as on March 5, 2021 at 3:39 am.

India

1,11,73,761 16838Cases

1,76,319 2906Active

1,08,39,894 13819Recovered

1,57,548 113Deaths

In India, there are 1,11,73,761 confirmed cases including 1,57,548 deaths. The number of active cases is 1,76,319 and 1,08,39,894 have recovered as on March 5, 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

21,88,183 8,998

86,359 2,803

20,49,484 6,135

52,340 60

DistrictCases

Kannur357

Kasaragod333

Palakkad224

Malappuram119

Kollam118

Thrissur106

Thiruvananthapuram104

Pathanamthitta98

Kozhikode90

Alappuzha76

Kottayam73

Ernakulam60

Idukki40

Wayanad36

10,69,660 2,616

44,734 1,554

10,20,671 4,156

4,255 14

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

9,53,136 571

6,147 71

9,34,639 496

12,350 4

DistrictCases

Kurnool795

Krishna557

Guntur511

Anantapur428

East Godavari356

Chittoor319

Sri Potti Sriramulu Nell*296

Y.S.R.205

West Godavari199

Srikakulam183

Prakasam104

Visakhapatnam103

Vizianagaram23

8,90,317 102

871 45

8,82,275 56

7,171 1

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

8,53,449 482

3,978 12

8,36,963 490

12,508 4

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

6,40,182 261

1,701 117

6,27,566 143

10,915 1

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

6,03,907 119

2,029 4

5,93,149 114

8,729 1

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

5,75,921 209

3,236 9

5,62,412 217

10,273 1

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

3,37,529 81

774 10

3,34,838 71

1,917

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

3,20,928 156

1,509 39

3,16,631 116

2,788 1

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

3,13,534 235

2,990 29

3,06,693 203

3,851 3

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

2,99,572 166

1,963 15

2,95,970 149

1,639 2

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

2,71,725 480

2,749 111

2,64,564 369

4,412

DistrictCases

Gurugram2,950

Faridabad867

Sonipat404

Rohtak145

Palwal120

Jhajjar114

Karnal104

Hisar98

Ambala93

Panipat78

Nuh68

Bhiwani60

Rewari56

Kurukshetra55

Sirsa50

Kaithal48

Mahendragarh47

CharkiDadri43

Panchkula39

Fatehabad38

Jind38

Yamunanagar19

2,71,659 294

1,615 145

2,66,992 149

3,052

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

2,63,290 440

3,308 211

2,56,116 228

3,866 1

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

2,62,668 40

348 1

2,60,777 40

1,543 1

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

2,17,613 20

1,626 5

2,14,894 15

1,093

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

1,85,381 1,071

6,264 671

1,73,230 385

5,887 15

DistrictCases

Anantnag395

Srinagar300

Kulgam295

Baramulla271

Shopian255

Kupwara231

Bandipora175

Udhampur155

Ramban151

Jammu138

Budgam110

Pulwama108

Kathua53

Rajouri39

Ganderbal37

Poonch35

Doda27

Reasi26

Samba25

Kishtwar10

Mirpur0

Muzaffarabad0

1,26,772 79

883 8

1,23,930 70

1,959 1

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

1,20,129 61

486 13

1,18,552 47

1,091 1

DistrictCases

Dehradun370

Nainital323

Tehri Garhwal110

Haridwar94

Udam Singh Nagar83

Almora71

Champawat45

Pithoragarh43

Chamoli36

PauriGarhwal36

Bageshwar31

Rudraprayag30

Uttar Kashi24

97,234 100

542 79

95,000 21

1,692

DistrictCases

Hamirpur117

Kangra105

Una41

Solan32

Chamba29

Bilaspur21

Mandi21

Sirmaur11

Shimla10

Kullu4

Kinnaur2

Lahaul And Spiti0

58,942 65

540 45

57,406 20

996

DistrictCases

South Goa69

North Goa57

55,212 69

639 29

53,775 38

798 2

DistrictCases

Pondicherry111

Mahe4

Karaikal2

Yanam0

39,794 17

166 2

38,959 19

669

DistrictCases

Dhalai196

Sepahijala174

Gomati74

South Tripura53

Unakoti49

West Tripura45

Khowai24

North Tripura14

33,424 2

32 1

33,001 3

391

DistrictCases

Churachandpur32

Kangpokpi26

Imphal West21

Thoubal18

Imphal East10

Tengnoupal9

Bishnupur7

Senapati6

Chandel5

Kamjong5

Ukhrul4

Jiribam3

Pherzawl3

Kakching2

Tamenglong2

Noney1

29,283

32 0

28,878

373

DistrictCases

Chandigarh313

22,040 78

545 42

21,140 36

355

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

16,838

2 0

16,780

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

13,966

13 1

13,805 1

148

DistrictCases

Dimapur20

Mon8

Kohima7

Kiphire3

Tuensang3

Peren2

Phek1

Longleng0

Mokokchung0

Wokha0

Zunheboto0

12,210 5

15 3

12,104 2

91

DistrictCases

Kargil77

LehLadakh43

9,824 3

43 1

9,651 2

130

DistrictCases

East District3

South District3

North District0

West District0

6,154 4

32 3

5,987 1

135

DistrictCases

South Andamans33

Nicobars1

North And Middle Andaman1

5,024 2

9 1

4,953 1

62

DistrictCases

Kolasib11

Aizawl10

Mamit8

Lawngtlai2

Lunglei2

Saitual1

Champhai0

Hnahthial0

Khawzawl0

Saiha0

Serchhip0

4,428 1

18 1

4,400 2

10

DistrictCases

Dadra And Nagar Haveli20

3,408

6 0

3,400

2

DistrictCases

Lakshadweep District0

425 11

115 13

309 24

1





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