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Pfizer-BioNTech Say COVID-19 Vaccine Protection Lasts At Least Six Months, Effective Against South African Variant

Safety data from the Phase 3 study has been collected from over 12,000 COVID vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile, Pfizer and BioNTech said in a joint statement

Pfizer-BioNTech Say COVID-19 Vaccine Protection Lasts At Least Six Months, Effective Against South African Variant
Highlights
  • Small trial of volunteers aged 12-15 showed 100% efficacy in that age group
  • Vaccine was 100% effective in preventing COVID-19 cases in South Africa
  • Vaccine safety now evaluated in over 44,000 participants aged 16 and above

New York: The ongoing Phase 3 clinical trial of Pfizer/BioNTech’s coronavirus vaccine has confirmed its protection lasts at least six months after the second dose. The companies said that the vaccine remains more than 91 per cent effective against disease with any symptoms for six months. The vaccine also appeared to be fully effective against the worrying B.1.351 variant of the virus — which is the dominant strain circulating in South Africa and which researchers feared had evolved to evade the protection of vaccines.

Also Read: Pfizer, Moderna Vaccines Against COVID-19 Highly Effective Even After First Shot: US Study

The vaccine was 100 per cent effective against severe disease as defined by the US Centers for Disease Control and Prevention (CDC), and 95.3 per cent effective against severe COVID-19 as defined by the US Food and Drug Administration (FDA). Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile, Pfizer and BioNTech said in a joint statement.

On Wednesday (March 1), the companies said a small trial of volunteers aged 12 to 15 showed 100 per cent efficacy in that age group.

These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the US FDA, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

He added, “The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”

Also Read: Pfizer Says Its COVID-19 Vaccine Protects Younger Teens

The company has been studying the vaccine in more than 46,000 volunteers and has noted 927 cases of confirmed COVID-19.

From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3 per cent, it said.

According to CNN, the FDA’s definition of severe disease included a raised respiratory rate indicating respiratory distress; raised heart rate, an oxygen saturation level of 93 per cent or lower; respiratory failure severe enough to need additional oxygen or ventilation; a blood pressure drop indicating shock; significant kidney, liver or neurological dysfunction and admission to an intensive care unit or death.

In South Africa, where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100 per cent (95 per cent CI, [53.5, 100.0]). In an exploratory analysis, the nine strains were sequenced and six of the nine were confirmed to be of the B.1.351 lineage, the company said.

Also Read: Do You Still Need Both Doses If You Have Already Had The Infection? WHO Expert Answers COVID-19 Vaccination FAQs

These datas support previous results from immunogenicity studies demonstrating that BNT162b2 induced a robust neutralising antibody response to the B1.351 variant, and although lower than to the wild-type strain, it does not appear to affect the high observed efficacy against this variant, the company stated. It also noted that no serious safety concerns were observed in trial participants up to six months after the second dose.

Side effects were generally consistent with previously reported results. Vaccine safety has now been evaluated in more than 44,000 participants aged 16 years and older with more than 12,000 vaccinated participants having at least six months of follow-up after their second dose, the statement read.

Also Read: When To Take Second Dose Of The COVID-19 Vaccine, How To Register For It, Government Answers These And Other Questions

(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

26,78,24,983Cases
22,84,48,447Active
3,40,97,388Recovered
52,79,148Deaths
Coronavirus has spread to 196 countries. The total confirmed cases worldwide are 26,78,24,983 and 52,79,148 have died; 22,84,48,447 are active cases and 3,40,97,388 have recovered as on December 9, 2021 at 3:47 am.

India

3,46,66,241 9,419Cases
94,742 1,009Active
3,40,97,388 8,251Recovered
4,74,111 159Deaths
In India, there are 3,46,66,241 confirmed cases including 4,74,111 deaths. The number of active cases is 94,742 and 3,40,97,388 have recovered as on December 9, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

66,40,888 893

9,964 157

64,89,720 1,040

1,41,204 10

Kerala

51,78,892 5,038

41,615 887

50,95,263 4,039

42,014 112

Karnataka

29,99,098 399

7,284 155

29,53,565 238

38,249 6

Tamil Nadu

27,32,648 703

7,946 36

26,88,142 728

36,560 11

Andhra Pradesh

20,74,217 181

2,011 3

20,57,749 176

14,457 2

Uttar Pradesh

17,10,502 10

139 7

16,87,452 3

22,911

West Bengal

16,20,803 574

7,576 0

15,93,659 568

19,568 6

Delhi

14,41,514 65

404 28

14,16,010 36

25,100 1

Odisha

10,50,760 255

1,931 11

10,40,403 264

8,426 2

Chhattisgarh

10,07,075 37

341 9

9,93,140 27

13,594 1

Rajasthan

9,54,984 40

236 16

9,45,792 24

8,956

Gujarat

8,27,873 67

417 45

8,17,361 22

10,095

Madhya Pradesh

7,93,288 14

140 1

7,82,619 13

10,529

Haryana

7,71,904 29

223 15

7,61,626 14

10,055

Bihar

7,26,259 9

36 6

7,14,133 3

12,090

Telangana

6,77,546 205

3,871 19

6,69,673 185

4,002 1

Assam

6,18,042 134

2,541 24

6,09,374 158

6,127

Punjab

6,03,578 22

350 0

5,86,614 20

16,614 2

Jharkhand

3,49,383 16

129 7

3,44,113 23

5,141

Uttarakhand

3,44,402 17

192 3

3,36,799 14

7,411

Jammu And Kashmir

3,38,198 151

1,639 38

3,32,070 111

4,489 2

Himachal Pradesh

2,27,753 69

722 14

2,23,174 81

3,857 2

Goa

1,79,307 65

441 37

1,75,478 28

3,388

Mizoram

1,37,377 320

3,049 10

1,33,819 309

509 1

Puducherry

1,29,128 23

230 1

1,27,022 22

1,876

Manipur

1,25,429 23

325 5

1,23,119 28

1,985

Tripura

84,888 14

94 11

83,968 3

826

Meghalaya

84,631 12

240 11

82,916 23

1,475

Chandigarh

65,515 7

67 2

64,628 5

820

Arunachal Pradesh

55,298 3

29 2

54,989 5

280

Sikkim

32,390 8

200 2

31,785 6

405

Nagaland

32,143 1

116 2

31,328 3

699

Ladakh

21,749 14

230 17

21,304 31

215

Dadra And Nagar Haveli

10,683

0 0

10,679

4

Lakshadweep

10,405

11 0

10,343

51

Andaman And Nicobar Islands

7,691 1

3 0

7,559 1

129

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