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DCGI Issues Guidelines For Pharma Giants Manufacturing COVID-19 Vaccine, Mandates Atleast 50 Per Cent Efficacy

The Drugs Controller General of India (DCGI) has said that a COVID-19 vaccine candidate should have at least 50 per cent of efficacy in the Phase-III clinical trial for it to be widely deployed

DCGI Issues Guidelines For Pharma Giants Manufacturing COVID-19 Vaccine, Mandates Atleast 50 Per Cent Efficacy
Highlights
  • The 3 important things for a vaccine are safety, immunogenicity, efficacy
  • Even WHO says that a vaccine needs to have over 50% efficacy: Dr Bhargava
  • We are aiming for 100% efficacy but may get 50-100%: Dr Balram Bhargava

New Delhi: The Drugs Controller General of India (DCGI) has issued a new set of guidelines, focusing on safety, immunogenicity and efficacy parameters for pharma giants who are developing COVID-19 vaccines. The DCGI has said that a COVID-19 vaccine candidate should have at least 50 per cent of efficacy in the Phase-III clinical trial for it to be widely deployed and adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) needs to be generated.

Also Read: Coronavirus Explainer: What Is COVAX Initiative?

The comprehensive draft regulator guideline for the development of a vaccine with special consideration for the COVID-19 vaccine provides guidance to the vaccine developers to ensure that — vaccines are well-characterised and manufactured consistently.

The guidance reads that considering the urgent need for a safe and effective vaccine for prevention of COVID-19, clinical development programs of the COVID-19 vaccine may proceed through an adaptive and seamless approach including data to inform the potential risk of vaccine-associated ERD will be needed.

The document has highlighted that the use of COVID-19 preventive vaccines in pregnancy and in women of childbearing potential is an important consideration for vaccination programs.

There are three things for a vaccine–(i) the safety, (ii) immunogenicity, and (iii) the efficacy. Even, WHO says that if we can get more than 50 per cent efficacy that is an accepted vaccine. For respiratory viruses, we never get 100 per cent efficacy. We are aiming for 100 per cent efficacy but may get 50-100 per cent, Dr Balram Bhargava, ICMR, Director-General said on Tuesday while responding to a query on the efficacy of COVID-19 vaccine.

Also Read: 30 COVID-19 Vaccine Candidates Under Development: Union Minister Harsh Vardhan

Dr Bhargava answered in view of the draft guidelines published by the Central Drugs Standard Control Organisation (CDSCO) for the development of a vaccine with special consideration for the COVID-19 vaccine.

The draft guidelines further say that the pharma companies for a statistical final analysis plan finalised before closing the trial database and unblinking treatment assignments (if these were blinded).

This should include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required.

If a trial fails to meet the predefined criteria for superiority and/or non-inferiority with respect to any of the antigenic components, the possible reasons for the result and the clinical implications of it should be carefully considered before proceeding with clinical development or licensure, noted the guidance.

Safety assessments throughout clinical development and all pregnancies in study participants for which the date of conception is prior to vaccination or within 30 days after vaccination should be followed for pregnancy outcomes, including pregnancy loss, stillbirth, and congenital anomalies, it said.

Also Read: Nine Months Into The COVID-19 Pandemic, Which Vaccine Candidates Are In The Final Stages Of Trial? 

COVID-19 vaccine trials should periodically monitor for unfavorable imbalances between vaccine and control groups in COVID-19 disease outcomes, in particular for cases of moderate to severe COVID-19 that may be a signal for vaccine-associated ERD. Studies should include pre-specified criteria for halting based on signals of potential vaccine-associated ERD.

It has also recommended the pharmaceutical companies to use an independent data safety monitoring board (DSMB) for vaccine-associated ERD and other safety signal monitoring, especially during later-stage development.

Also Read: Coronavirus Explained: What Are The Phases In The Clinical Trials Of The COVID-19 Vaccine?

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.) 

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World

26,58,63,058Cases
22,65,37,591Active
3,40,69,608Recovered
52,55,859Deaths
Coronavirus has spread to 196 countries. The total confirmed cases worldwide are 26,58,63,058 and 52,55,859 have died; 22,65,37,591 are active cases and 3,40,69,608 have recovered as on December 6, 2021 at 5:12 am.

India

3,46,41,561 8,306Cases
98,416739Active
3,40,69,608 8,834Recovered
4,73,537 211Deaths
In India, there are 3,46,41,561 confirmed cases including 4,73,537 deaths. The number of active cases is 98,416 and 3,40,69,608 have recovered as on December 6, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,38,778 707

10,826 23

64,86,782 677

1,41,170 7

Kerala

51,65,921 4,450

44,110 317

50,80,211 4,606

41,600 161

Karnataka

29,98,099 456

7,161 120

29,52,708 330

38,230 6

Tamil Nadu

27,30,516 724

8,041 29

26,85,946 743

36,529 10

Andhra Pradesh

20,73,730 154

2,122 27

20,57,156 177

14,452 4

Uttar Pradesh

17,10,475 24

134 18

16,87,430 6

22,911

West Bengal

16,19,257 620

7,639 17

15,92,074 627

19,544 10

Delhi

14,41,358 63

370 48

14,15,890 15

25,098

Odisha

10,50,249 189

2,154 25

10,39,673 212

8,422 2

Chhattisgarh

10,06,967 25

330 4

9,93,044 21

13,593

Rajasthan

9,54,891 17

221 8

9,45,715 9

8,955

Gujarat

8,27,707 48

349 23

8,17,263 24

10,095 1

Madhya Pradesh

7,93,241 9

133 9

7,82,580 18

10,528

Haryana

7,71,819 22

185 5

7,61,580 17

10,054

Bihar

7,26,237 6

26 4

7,14,121 2

12,090

Telangana

6,76,943 156

3,787 8

6,69,157 147

3,999 1

Assam

6,17,576 101

2,490 61

6,08,966 158

6,120 4

Punjab

6,03,488 37

361 14

5,86,519 23

16,608

Jharkhand

3,49,342 25

127 12

3,44,074 13

5,141

Uttarakhand

3,44,353 8

174 1

3,36,768 7

7,411

Jammu And Kashmir

3,37,807 161

1,706 25

3,31,620 184

4,481 2

Himachal Pradesh

2,27,518 35

755 45

2,22,911 80

3,852

Goa

1,79,174 49

412 18

1,75,375 31

3,387

Mizoram

1,36,454 92

3,101 454

1,32,846 544

507 2

Puducherry

1,29,085 29

280 14

1,26,930 43

1,875

Manipur

1,25,360 32

353 9

1,23,025 40

1,982 1

Tripura

84,858 5

90 1

83,943 6

825

Meghalaya

84,583 9

244 2

82,864 11

1,475

Chandigarh

65,488 7

58 2

64,610 9

820

Arunachal Pradesh

55,293 5

36 4

54,977 1

280

Sikkim

32,369 10

215 2

31,749 8

405

Nagaland

32,136

117 9

31,320 9

699

Ladakh

21,714 31

295 3

21,204 34

215

Dadra And Nagar Haveli

10,683

0 0

10,679

4

Lakshadweep

10,404

10 0

10,343

51

Andaman And Nicobar Islands

7,688

4 2

7,555 2

129

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