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Johnson & Johnson Pauses Coronavirus Vaccine Trial After Volunteer Falls Ill

Pharmaceutical company Johnson & Johnson paused the advance clinical trial of ENSEMBLE, one of its coronavirus vaccines, after an unexplained illness was found in one of the volunteers

Johnson & Johnson Pauses Coronavirus Vaccine Trial After Volunteer Falls Ill
Highlights
  • Johnson & Johnson hasn’t yet revealed details about the unexplained illness
  • Phase three trial of Johnson's coronavirus vaccine started in September
  • It's one of six coronavirus vaccines being tested in the United States

Washington: Pharmaceutical company Johnson & Johnson announced on Monday (October 12) that it has paused the advance clinical trial, ENSEMBLE, of one of its vaccines after an unexplained illness was found in one of the volunteers. In a statement, the company said, “Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” ENSEMBLE being the name of the study, CNN reported.

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The injection is being developed by the Janssen vaccine arm of Johnson & Johnson. The company has not yet revealed details about the unexplained illness but has stopped trials while doctors find out if the illness was caused due to the vaccine or was a coincidence. The idea behind clinical trials is to explore the dangerous side effects of vaccination.

Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies, the company added.

The company also claimed its strong commitment to safety. All clinical trials carried out by the Janssen Pharmaceutical Company have prespecified guidelines that maintain that studies must be paused in case an unforeseen serious adverse event (SAE) is noticed in relation to the vaccine so there can be a careful review of all medical information.

We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.

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The drugmaker said,

Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.

The Dean of the Brown University School of Public Health Ashish Jha said that this pause is not immediately concerning. “This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3,” Mr Jha told CNN.

The Johnson & Johnson trial is the biggest trial of the vaccine that I know of — 60,000 people,” Mr Jha said. “Within that trial you’d expect a few pauses, he added.

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However, the drugmaker claimed that there is a “significant distinction” between a study pause and a regulatory hold on a clinical trial.

It further said that a study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol.

After AstraZeneca’s vaccine trial, this is the second Phase Three vaccine trial to be paused in the US. However, the trial has resumed there and in other countries but still remains paused in the United States while the US Food and Drug Administration investigates.

Mr Jha further said that they want the vaccine to be safe. “To me, it’s reassuring that companies are acting responsibly and pausing when they need to.”

Phase Three trial of Johnson’s vaccine started in September. It’s one of six coronavirus vaccines being tested in the US, and one of four in the most advanced stage. It requires just one dose and hence, federal officials have said they hope testing may be completed a bit faster than other vaccines, including those being made by Moderna and Pfizer, which require two doses, CNN further reported.

Also Read: COVID-19 Vaccine Roundup: Trials Of Oxford Vaccine Candidate, A Frontrunner In The Global Race, Are Paused After Unexplained Illness Occurred In A Volunteer

(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

26,58,63,058Cases
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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