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India Wants Pfizer To Do Local Study Before Approval: Official

According to Vinod K. Paul, who heads a government panel on vaccine strategy, the pre-condition for any vaccine to be implemented in India is a bridging trial

India Wants Pfizer To Do Local Study Before Approval: Official
Highlights
  • Pfizer had applied for emergency use of its COVID-19 vaccine in India
  • A bridging trial is required before implementation of any vaccine in India
  • Bridging trials determine safety and immunogenicity of a vaccine

New Delhi: Any vaccine maker, including Pfizer Inc that has sought emergency-use authorisation for its COVID-19 shot in India, must conduct an additional local study to be considered for the country’s immunisation programme, a senior government official told Reuters. Serum Institute of India, the local manufacturer of the vaccine developed by AstraZeneca Plc and Oxford University, did a months long local study on more than 1,500 people before seeking and receiving emergency approval on Jan. 3. India, which has reached 10.5 million coronavirus infections – the second highest in the world after the United States – has also approved a homegrown vaccine made by Bharat Biotech ahead of its inoculation campaign which starts on Saturday (January 16).

Also Read: India Gears Up For Mega COVID Vaccination Drive, A Look At Vaccination Process On Ground

Local media have reported that Pfizer had sought to import and distribute its vaccine in India without doing local trials. In early December, it was the first company to seek emergency-use approval in the world’s second-most populous country but has not attended subsequent meetings called by India’s Central Drugs Standard Control Organization, according to minutes of the deliberations released on the drugs regulator’s website.

As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial, Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview in his office near the parliament building.

Also Read: Bharat Biotech Dispatches COVID-19 Vaccine Covaxin To 11 Cities, Donates 16.5 Lakh Doses To Government

The government has already distributed 16.5 million doses of the two approved vaccines to states, with a plan to deliver 600 million jabs to the most vulnerable people in the next six to eight months. Serum Institute has stockpiled 50 million doses of the AstraZeneca vaccine and says it will raise its monthly output to much more than that now the approval has come.

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens whose genetic makeup can be different from people in western nations. There are, however, provisions under India’s New Drugs and Clinical Trial Rules, 2019, to waive such trials in certain conditions.

A Pfizer spokeswomen had no immediate comment.

Also Read: COVID-19 Outbreak Explained: Can COVID-19 Vaccines Fight Against Virus Mutations?

The Pfizer vaccine, developed in partnership with Germany’s BioNTech SE, is already being administered to people in countries such as the United States and Britain. It was not immediately clear if any other countries had asked for similar smaller local trials before approving vaccines developed and tested abroad.

Dr Paul said Indian officials have had discussions with Pfizer and Moderna Inc – both U.S. companies have reported more than 90 per cent efficacy for their vaccines – to make the shots in India given its large pharmaceutical capacity. India is the world’s biggest vaccine maker.

Dr Paul, a paediatrician who had taught at the state-run All India Institute of Medical Sciences, also said Russia’s Sputnik V, which is now undergoing last-stage trials in India after completing a Phase 2 study there, will soon apply for emergency-use approval in the country.

No vaccine maker will be given indemnity by the government should something go wrong, Dr Paul said. Serum Institute had written to the government seeking indemnity. AstraZeneca has said it has received such indemnity in many other countries.

Also Read: Russian COVID-19 Vaccine Sputnik V Meets Primary Safety Endpoint In Phase-2 Clinical Trials In India

(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

26,43,68,460Cases
22,50,84,762Active
3,40,45,666Recovered
52,38,032Deaths
Coronavirus has spread to 196 countries. The total confirmed cases worldwide are 26,43,68,460 and 52,38,032 have died; 22,50,84,762 are active cases and 3,40,45,666 have recovered as on December 3, 2021 at 1:36 pm.

India

3,46,15,757 9,216Cases
99,976 213Active
3,40,45,666 8,612Recovered
4,70,115 391Deaths
In India, there are 3,46,15,757 confirmed cases including 4,70,115 deaths. The number of active cases is 99,976 and 3,40,45,666 have recovered as on December 3, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,37,221 796

10,882 180

64,85,290 952

1,41,049 24

Kerala

51,51,919 4,700

45,030 252

50,66,034 4,128

40,855 320

Karnataka

29,96,833 363

6,772 169

29,51,845 191

38,216 3

Tamil Nadu

27,28,350 715

8,155 45

26,83,691 748

36,504 12

Andhra Pradesh

20,73,252 159

2,138 11

20,56,670 169

14,444 1

Uttar Pradesh

17,10,417 12

93 1

16,87,413 11

22,911

West Bengal

16,17,408 657

7,690 22

15,90,208 667

19,510 12

Delhi

14,41,190 217

307 21

14,15,785 196

25,098

Odisha

10,49,597 252

2,211 26

10,38,971 276

8,415 2

Chhattisgarh

10,06,870 37

328 12

9,92,949 25

13,593

Rajasthan

9,54,827 21

213 10

9,45,659 11

8,955

Gujarat

8,27,570 50

318 25

8,17,158 24

10,094 1

Madhya Pradesh

7,93,199 12

128 4

7,82,543 8

10,528

Haryana

7,71,760 27

178 9

7,61,528 18

10,054

Bihar

7,26,230 5

32 0

7,16,534 4

9,664 1

Telangana

6,76,376 189

3,680 50

6,68,701 137

3,995 2

Assam

6,17,163 124

2,535 77

6,08,517 198

6,111 3

Punjab

6,03,352 32

344 13

5,86,402 18

16,606 1

Jharkhand

3,49,271 15

95 1

3,44,035 13

5,141 1

Uttarakhand

3,44,325 22

182 4

3,36,735 18

7,408

Jammu And Kashmir

3,37,263 177

1,697 10

3,31,089 167

4,477

Himachal Pradesh

2,27,354 85

835 29

2,22,669 113

3,850 1

Goa

1,79,046 56

367 40

1,75,295 16

3,384

Mizoram

1,35,765 315

3,717 55

1,31,545 368

503 2

Puducherry

1,28,998 33

299 10

1,26,826 23

1,873

Manipur

1,25,269 33

663 4

1,22,627 28

1,979 1

Tripura

84,835 15

94 6

83,916 8

825 1

Meghalaya

84,534 24

296 2

82,764 25

1,474 1

Chandigarh

65,475 4

65 1

64,590 5

820

Arunachal Pradesh

55,285 6

36 1

54,969 5

280

Sikkim

32,267 15

137 10

31,727 5

403

Nagaland

32,128 3

128 5

31,302 6

698 2

Ladakh

21,642 41

306 21

21,122 20

214

Dadra And Nagar Haveli

10,683

0 1

10,679 1

4

Lakshadweep

10,397 1

18 8

10,328 9

51

Andaman And Nicobar Islands

7,686 3

7 2

7,550 1

129

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