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Indigenous COVID-19 Vaccine, Covaxin’s Phase 2 Data Published In Lancet; Vaccine Safe, Induced High Neutralising Antibody

In the phase 2 trial, the Bharat Biotech-ICMR’s COVID-19 vaccine showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial

Indigenous COVID-19 Vaccine, Covaxin's Phase 2 Data Published In Lancet; Vaccine Safe, Induced High Neutralising Antibody
Highlights
  • COVID-19 Covaxin has already got emergency use license in India
  • Phase 1 trial of Covaxin induced high neutralising antibody responses
  • Less participants reported adverse events in the phase 2 trial than phase 1

New Delhi: British medical journal The Lancet on Tuesday (March 9) published the phase 2 results of the “Made in India” COVID-19 vaccine, Covaxin, stating that the vaccine has better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial. No severe or life-threatening adverse events were reported, it added. Report named as Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial and 3-month follow-up of a double-blind, randomised phase 1 trial published the assessment.

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

The reactogenicity assessments reported in this study were substantially better in the phase 2 trial than the phase 1 trial and other trials with a placebo group. Additionally, the proportion of participants reporting adverse events in the phase 2 trial were lower than in the phase 1 trial, Lancet report says.

Describing the outcome in terms of adverse effect, Lancet said “Most common adverse event in the phase 2 trial was pain at the injection site, followed by headache, fatigue, and fever. No severe or life-threatening (i.e., grade 4 and 5) solicited adverse events were reported. No significant differences in safety were observed between the two groups.”

According to the journal, the phase 1 trial, BBV152 induced high neutralising antibody responses that remained elevated in all participants at 3 months after the second vaccination.

In the phase 2 trial, the Bharat Biotech vaccine showed better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with the phase 1 trial, it said.

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

No cases of COVID-19 were reported in either group of the phase 2 trial, whereas one case of symptomatic COVID-19 was reported in the Algel-only control group of the phase 1 trial. According to the report, “To ensure generalisability of the results, this study included participants from diverse geographic locations, enrolling 380 participants across nine hospitals across nine states in India. Based on follow-up data from the phase 1 trial, despite a marginal expected decline in neutralising antibody titres at day 104, BBV152 has shown the potential to provide durable humoral and cell-mediated immune responses.”

In phase 2, the first dose administered on day 0 and the second dose on day 28.

Also Read: Phase 3 Clinical Trials Of COVID-19 Vaccine, Covaxin Shows 81 Per Cent Efficacy, Says Bharat Biotech

Bharat Biotech earlier released results of Phase 3 clinical trials of its coronavirus vaccine Covaxin, with the drug demonstrating 81 per cent interim efficacy against COVID-19.

The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its phase III clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research (ICMR), the biotech company said in a release.

The company said the phase III study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with co-morbidities.

The primary endpoint of phase III clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline, it stated.

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

(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

26,21,50,955Cases
22,29,25,306Active
3,40,18,299Recovered
52,07,350Deaths
Coronavirus has spread to 196 countries. The total confirmed cases worldwide are 26,21,50,955 and 52,07,350 have died; 22,29,25,306 are active cases and 3,40,18,299 have recovered as on November 30, 2021 at 3:50 am.

India

3,45,87,822 6,990Cases
1,00,5433,316Active
3,40,18,299 10,116Recovered
4,68,980 190Deaths
In India, there are 3,45,87,822 confirmed cases including 4,68,980 deaths. The number of active cases is 1,00,543 and 3,40,18,299 have recovered as on November 30, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,34,980 536

11,525 338

64,82,493 853

1,40,962 21

Kerala

51,37,091 3,382

45,138 2,514

50,51,998 5,779

39,955 117

Karnataka

29,95,857 257

6,907 47

29,50,747 205

38,203 5

Tamil Nadu

27,26,197 730

8,291 46

26,81,434 767

36,472 9

Andhra Pradesh

20,72,725 101

2,102 38

20,56,184 138

14,439 1

Uttar Pradesh

17,10,387 5

86 3

16,87,391 2

22,910

West Bengal

16,15,378 511

7,733 71

15,88,172 571

19,473 11

Delhi

14,40,900 34

285 3

14,15,517 36

25,098 1

Odisha

10,48,880 197

2,165 26

10,38,306 221

8,409 2

Chhattisgarh

10,06,779 16

318 12

9,92,868 28

13,593

Rajasthan

9,54,770 12

187 12

9,45,628 24

8,955

Gujarat

8,27,435 27

262 22

8,17,081 49

10,092

Madhya Pradesh

7,93,150 12

126 4

7,82,496 8

10,528

Haryana

7,71,692 16

165 3

7,61,473 19

10,054

Bihar

7,26,219 2

39 2

7,16,517 4

9,663

Telangana

6,75,798 184

3,581 46

6,68,227 137

3,990 1

Assam

6,16,708 140

2,595 96

6,08,015 230

6,098 6

Punjab

6,03,258 18

329 11

5,86,330 26

16,599 3

Jharkhand

3,49,232 11

95 2

3,43,997 9

5,140

Uttarakhand

3,44,227 8

132 44

3,36,687 51

7,408 1

Jammu And Kashmir

3,36,681 150

1,626 32

3,30,579 181

4,476 1

Himachal Pradesh

2,27,093 90

824 29

2,22,422 61

3,847

Goa

1,78,890 24

276 3

1,75,230 19

3,384 2

Mizoram

1,34,810 437

3,805 95

1,30,512 531

493 1

Puducherry

1,28,893 12

296 16

1,26,725 28

1,872

Manipur

1,25,169 17

655 30

1,22,539 43

1,975 4

Tripura

84,791 4

78 8

83,890 10

823 2

Meghalaya

84,461 17

285 16

82,704 32

1,472 1

Chandigarh

65,456 8

58 4

64,578 4

820

Arunachal Pradesh

55,273 4

35 2

54,958 2

280

Sikkim

32,233 5

121 6

31,709 11

403

Nagaland

32,109 9

140 5

31,273 4

696

Ladakh

21,540 12

250 18

21,076 29

214 1

Dadra And Nagar Haveli

10,683

1 0

10,678

4

Lakshadweep

10,394

24 4

10,319 4

51

Andaman And Nicobar Islands

7,683 2

8 2

7,546

129

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