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India Approves Oxford’s, Bharat Biotech’s COVID-19 Vaccines For Restricted Emergency Use

Oxford-AstraZeneca’s coronavirus vaccine Covishield and Bharat Biotech’s Covaxin are country’s first vaccines to receive regulatory approval for emergency use to fight the COVID-19 pandemic

India Approves Oxford's, Bharat Biotech's COVID-19 Vaccines For Restricted Emergency Use
Highlights
  • Covishield and Covaxin have to be administered in two doses
  • Bother vaccines have to be stored at 2-8° C: Dr V G Somani
  • Pfizer had also applied for regulatory approval for its vaccine in December

New Delhi: India’s drugs regulator on Sunday approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, paving the way for a massive inoculation drive. The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). “After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” DCGI Dr V G Somani told the media here.

Also Read: A Scoring System To Ensure High Risk Individuals Get Immunised First, Says AIIMS Director As India Approve COVID-19 Vaccines For Emergency Use

This paves the way for the roll out of at least two vaccines in India in the coming days.

Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C, he said.

The Serum Institute of India, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield, while Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

Prime Minister Narendra Modi termed the approval a decisive turning point in India’s fight against coronavirus.

DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators,” he tweeted.

It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion, he said in another tweet.

He also saluted the frontline workers who have been leading the country’s fight against the virus.

Serum Institute of India’s CEO Adar Poonawalla tweeted,

COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks.

In his media statement, Dr Somani also said Cadila Healthcare has been granted the permission to conduct the Phase III clinical trial of its vaccine candidate in India.

Pune-based SII’s shot is a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield), encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University.

The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42 per cent, Dr Somani said.

Also Read: All Set For Roll-Out, Just Waiting For COVID-19 Vaccine To Arrive In Delhi: Minister Satyendar Jain

Further, Serum Institute was granted permission to conduct Phase-2/3 clinical trials on 1,00 participants within the country, he said.

The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies. The clinical trial ongoing within the country by the firm will continue. Bharat Biotech has developed a Whole Virion Inactivated Coronavirus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country & globally. The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters, he said. All these data have been shared by the firm with CDSCO, he said. On Covaxin, Somani said,

The Phase 1 and Phase 2 clinical trials were conducted on approx 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response, he said. The Phase 3 efficacy trial was initiated in India on 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date, Somani said.

The SEC has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue, he said.

SII had applied to the DCGI for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its Covaxin on December 7.

In terms of safety, Covishield was well tolerated…majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe and can be used effectively for prevention of COVID-19 in the targeted population, the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.

Pfizer had also applied for regulatory approval for its vaccine on December 4 but not much progress has been made on it after that.

Also Read: India Rehearses For Massive Coronavirus Vaccination Drive; Vardhan Assures People On Safety Of 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

23,96,06,768Cases
20,13,42,617Active
3,33,82,100Recovered
48,82,051Deaths
Coronavirus has spread to 195 countries. The total confirmed cases worldwide are 23,96,06,768 and 48,82,051 have died; 20,13,42,617 are active cases and 3,33,82,100 have recovered as on October 15, 2021 at 4:15 am.

India

3,40,37,592 16,862Cases
2,03,6782,908Active
3,33,82,100 19,391Recovered
4,51,814 379Deaths
In India, there are 3,40,37,592 confirmed cases including 4,51,814 deaths. The number of active cases is 2,03,678 and 3,33,82,100 have recovered as on October 15, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

65,86,280 2,384

33,157 6

64,13,418 2,343

1,39,705 35

Kerala

48,29,944 9,246

96,421 1,802

47,06,856 10,952

26,667 96

Karnataka

29,82,399 310

9,607 43

29,34,870 347

37,922 6

Tamil Nadu

26,83,396 1,259

15,451 199

26,32,092 1,438

35,853 20

Andhra Pradesh

20,59,122 540

6,588 27

20,38,248 557

14,286 10

Uttar Pradesh

17,10,008 12

135 4

16,86,976 16

22,897

West Bengal

15,79,012 530

7,576 81

15,52,491 601

18,945 10

Delhi

14,39,311 28

337 1

14,13,885 29

25,089

Odisha

10,33,809 521

4,890 38

10,20,645 477

8,274 6

Chhattisgarh

10,05,614 16

203 4

9,91,841 20

13,570

Rajasthan

9,54,382 8

42 6

9,45,386 2

8,954

Gujarat

8,26,244 34

215 20

8,15,943 14

10,086

Madhya Pradesh

7,92,669 12

111 1

7,82,035 11

10,523

Haryana

7,71,035 16

105 158

7,60,881

10,049 174

Bihar

7,26,016 8

42 6

7,16,313 2

9,661

Telangana

6,68,618 168

4,171 40

6,60,512 207

3,935 1

Assam

6,05,847 207

3,646 157

5,96,263 362

5,938 2

Punjab

6,01,971 33

234 11

5,85,199 16

16,538 6

Jharkhand

3,48,406 11

130 4

3,43,141 7

5,135

Uttarakhand

3,43,729 28

175 22

3,36,157 6

7,397

Jammu And Kashmir

3,30,834 93

935 11

3,25,473 104

4,426

Himachal Pradesh

2,21,113 182

1,387 5

2,16,011 173

3,715 4

Goa

1,77,356 68

679 27

1,73,342 39

3,335 2

Puducherry

1,27,259 49

647 4

1,24,763 53

1,849

Manipur

1,22,432 69

1,444 15

1,19,099 84

1,889

Mizoram

1,10,719 901

13,601 435

96,744 1,332

374 4

Tripura

84,295 4

110 8

83,369 12

816

Meghalaya

82,734 87

892 31

80,411 115

1,431 3

Chandigarh

65,295 10

32 5

64,443 15

820

Arunachal Pradesh

54,958 4

202 22

54,476 26

280

Sikkim

31,722 6

224 1

31,108 7

390

Nagaland

31,516 9

230 8

30,613 17

673

Ladakh

20,867 6

44 2

20,615 4

208

Dadra And Nagar Haveli

10,675

3 1

10,668 1

4

Lakshadweep

10,365

2 0

10,312

51

Andaman And Nicobar Islands

7,640 3

10 1

7,501 2

129

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