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Russian COVID-19 Vaccine Safe, Induces Antibody Response In Small Trials: Lancet Study

According to the results of Russia’s ‘Sputnik V’ COVID-19 vaccine candidate published in The Lancet journal, most common adverse effects of the vaccine were pain at the injection site, hyperthermia, headache, asthenia (weakness or lack of energy), and muscle and joint pain

Russian COVID-19 Vaccine Safe, Induces Antibody Response In Small Trials: Lancet Study
Highlights
  • Russia approved 'Sputnik V' COVID-19 vaccine candidate last month
  • Sputnik V uses adenovirus which usually causes the common cold
  • Sputnik V trials took place in two hospitals in Russia

Moscow: Russia’s ‘Sputnik V’ COVID-19 vaccine, approved in the country last month, produced antibody response in all participants with no serious adverse events in small human trials, according to the first peer-reviewed results of the preventive published in The Lancet journal on Friday. Results from early-phase non-randomised vaccine trials in a total of 76 people show that two formulations of the vaccine have a good safety profile detected over 42 days, and induce antibody responses in all participants within 21 days.

Also Read: Russia Becomes First Country To Approve A COVID-19 Vaccine, Says President Putin

Secondary outcomes from the trial suggest the vaccine, approved last month by Russia, also produces a T cell response within 28 days, the researchers said. The two-part vaccine includes recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S), which have been modified to express the SARS-CoV-2 spike protein.

The adenoviruses, which usually cause the common cold, are also weakened so that they cannot replicate in human cells and cannot cause disease, according to the researchers. These vaccines aim to stimulate both arms of the immune system — antibody and T cell responses — so they attack the virus when it is circulating in the body, and also attack cells infected by SARS-CoV-2.

When adenovirus vaccines enter people’s cells, they deliver the SARS-CoV-2 spike protein genetic code, which causes cells to produce the spike protein. This helps teach the immune system to recognise and attack the SARS-CoV-2 virus. To form a powerful immune response against SARS-CoV-2, it is important that a booster vaccination is provided, said study lead author Denis Logunov, from Gamaleya National Research Centre for Epidemiology and Microbiology, Russia.

The trials took place in two hospitals in Russia, and were open-label and non-randomised, meaning that participants knew that they were receiving the vaccine and were not assigned by chance to different treatment groups. The trials involved healthy adults aged 18-60 years, who self-isolated as soon as they were registered, and remained in hospital for the first 28 days of the trial from when they were first vaccinated.

Also Read: Minimal SARS-CoV-2 Diversity Suggests Global Vaccine Is Feasible: Study

In the phase 1 of each trial, participants received one component of the two-part vaccine — four groups of nine participants were given the frozen or freeze-dried rAd26-S or rAd5-S component. In the phase 2, which began no earlier than five days after the phase 1 trial began, participants received the full two-part vaccine.

There were 20 participants each in the frozen and freeze-dried vaccine groups, the Lancet study noted. To compare post-vaccination immunity with natural immunity formed by infection with SARS-CoV-2, the authors obtained convalescent plasma from 4,817 people who had recovered from mild or moderate COVID-19, they said. Both vaccine formulations were safe over the 42-day study period and well tolerated, according to the study. The most common adverse events were pain at the injection site, hyperthermia, headache, asthenia (weakness or lack of energy), and muscle and joint pain.

The authors note that these adverse effects are also seen with other vaccines, particularly those based on recombinant viral vectors. Responding to the findings, Naor Bar-Zeev from Johns Hopkins Bloomberg School of Public Health, US, who was not involved in the study said the trial results are encouraging but small on scale.

The immunogenicity bodes well, although nothing can be inferred on immunogenicity in older age groups, and clinical efficacy for any COVID-19 vaccine has not yet been shown. Showing safety will be crucial with COVID-19 vaccines, not only for vaccine acceptance but also for trust in vaccination broadly, Professor Bar-zeev said.

The authors note some limitations to their study, including that it had a short follow-up (42 days), it was a small study, some parts of the phase 1 trials included only male volunteers, and there was no placebo or control vaccine. In addition, they note that despite planning to recruit healthy volunteers aged 18-60 years, in general, their study included fairly young volunteers (in their 20s and 30s, on average).

They say that more research is needed to evaluate the vaccine in different populations, including older age groups, individuals with underlying medical conditions, and people in at-risk groups. Explaining the next steps of their research, Professor Alexander Gintsburg, from Gamaleya National Research Centre for Epidemiology and Microbiology said the phase 3 clinical trial of the vaccine has been approved on August 26, 2020.

It is planned to include 40,000 volunteers from different age and risk groups, and will be undertaken with constant monitoring of volunteers through an online application, Professor Gintsburg added.

Also Read: Serum Institute Of India Partners With The Gates Foundation For Manufacturing 100 Million Doses Of COVID-19 Vaccine

(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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