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Explainer: How Worried Should We Be About Reports Of Blood Clots And Astrazeneca’s Vaccine?

According to experts, the vaccines developed by Pfizer and Moderna have been linked with increased risk of anaphylaxis, but they are still recommended because benefits outweigh the risks of the side effect, which can be treated

Explainer: How Worried Should We Be About Reports Of Blood Clots And Astrazeneca's Vaccine?

Frankfurt/Paris: Europe’s medicines watchdog concluded on Thursday (March 18) that AstraZeneca’s coronavirus vaccine still far outweighed any risks after investigating reports of rare blood clotting disorders but said it would add a warning to the product leaflet. “A causal link with the vaccine is not proven, but is possible and deserves further analysis,” the European Medicines Agency (EMA) said. The World Health Organization has previously also said there was no proven link and that the benefits far outweighed any risks.

Also Read: More Private Facilities Being Allowed As COVID Vaccination Centres In Delhi, 3 States: Government

At least 13 EU member states including Germany, France and Italy have suspended use of the shot pending the outcome of EMA’s probe. Here’s what we know so far:

What Has Happened?

More than 45 million shots by various manufacturers have been administered across the EU and the European Economic Area since vaccinations started almost three months ago. The AstraZeneca vaccine was given to 5 million people in the EU.

EMA said it had reviewed seven cases of blood clots in multiple blood vessels, called disseminated intravascular coagulation (DIC) and 18 cases of cerebral venous sinus thrombosis (CVST) in people who had received the AstraZeneca shot, most of whom were women.

In Germany, eight people have been diagnosed with CVST within about two weeks of vaccination among the 1.6 million recipients of the shot as of Wednesday, according to the health ministry. Normally 1 to 1.4 cases would have been expected during that time, the ministry added.

Germany’s vaccine authority Paul Ehrlich Institute (PEI) has said the majority of the cases were young to middle-aged women and that there had been three deaths.

What Have Other Countries And Astrazeneca Said?

In Britain, where more than 11 million doses of the AstraZeneca vaccine have been administered, the medicines regulator said on Thursday it was investigating five cases of CVST among recipients but it reiterated that the benefits of the shot far outweighed any possible risks.

Canada has said health experts are sure all COVID-19 vaccines being administered in the country are safe, including AstraZeneca’s.

AstraZeneca said on Sunday a review of safety data of more than 17 million people vaccinated in the United Kingdom and European Union with its vaccine had shown no evidence of an increased risk of blood clots.

Also Read: 100-Year-Old Woman Gets First Dose Of COVID-19 Vaccine In Delhi

What Was The Ema Investigating?

EMA investigators checked if the frequency of incidences was higher in the vaccinated population than normal background rates.

The normal frequency is drawn from public health statistics or insurance records. This would be combined with a medical analysis of each case and insight from scientific literature.

EMA’s head of safety monitoring, Peter Arlett, said on Tuesday the rarity of CVST meant the watchdog would have to rely more heavily on case-by-case analysis rather than on statistical data.

A spokeswomen for Germany’s vaccine authority, which is part of the investigation, said prior to the safety review that EMA would not rule on causality.

Instead, EMA would assess the likelihood of an increased risk of the condition and weigh that against the benefits of fighting COVID-19.

For example, the vaccines developed by Pfizer and Moderna have been linked with increased risk of anaphylaxis, but they are still recommended because benefits outweigh the risks of the side effect, which can be treated.

Also Read: Oxford-Astrazeneca Coronavirus Vaccine Is ‘Safe And Effective’: European Medicines Agency

What Did The Clinical Trials Show?

AstraZeneca and European regulators have said that concerns about blood coagulation disorders did not emerge during human trials.

Safety monitoring after approval is key because extremely rare side-effects, or those affecting only a small subset of the population, are near impossible to identify during clinical trials, according to Germany’s PEI.

Are There Precedents Of Vaccine Safety Scares?

In Japan, a governmental recommendation for use of human papillomavirus (HPV) vaccine to prevent cervical cancer has been suspended since June 2013, due to media reports of an alleged pain syndrome. This has drawn criticism from the WHO.

A study published in The Lancet Public Health last year concluded a continued suspension would lead to thousands of cancer deaths over the next decades.

In Ukraine, deep mistrust of vaccines has allowed measles to grow into an epidemic. Vaccine hesitancy there is rooted in corruption and mistrust of authority but also in a temporary government suspension in 2008, when a 17-year-old boy died shortly after receiving a measles-rubella vaccine.

Also Read: India Surpasses Single Day Record With Over 3 Million Vaccinations In One Day

(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

24,06,78,961Cases
20,23,40,977Active
3,34,39,331Recovered
48,98,653Deaths
Coronavirus has spread to 195 countries. The total confirmed cases worldwide are 24,06,78,961 and 48,98,653 have died; 20,23,40,977 are active cases and 3,34,39,331 have recovered as on October 18, 2021 at 4:17 am.

India

3,40,81,315 13,596Cases
1,89,6946,152Active
3,34,39,331 19,582Recovered
4,52,290 166Deaths
In India, there are 3,40,81,315 confirmed cases including 4,52,290 deaths. The number of active cases is 1,89,694 and 3,34,39,331 have recovered as on October 18, 2021 at 2:30 am.

State Details

State Cases Active Recovered Deaths
Maharashtra

65,91,697 1,715

32,230 994

64,19,678 2,680

1,39,789 29

Kerala

48,54,321 7,555

88,186 3,292

47,39,270 10,773

26,865 74

Karnataka

29,83,459 326

9,479 58

29,36,039 380

37,941 4

Tamil Nadu

26,87,092 1,218

14,814 208

26,36,379 1,411

35,899 15

Andhra Pradesh

20,60,472 432

6,034 159

20,40,131 586

14,307 5

Uttar Pradesh

17,10,028 9

119 10

16,87,011 19

22,898

West Bengal

15,80,530 624

7,421 24

15,54,132 634

18,977 14

Delhi

14,39,390 32

320 6

14,13,981 38

25,089

Odisha

10,35,077 443

4,542 68

10,22,250 508

8,285 3

Chhattisgarh

10,05,654 16

183 2

9,91,901 14

13,570

Rajasthan

9,54,390 2

42 2

9,45,394 4

8,954

Gujarat

8,26,290 10

207 6

8,15,997 16

10,086

Madhya Pradesh

7,92,684 5

84 12

7,82,077 17

10,523

Haryana

7,71,076 15

123 9

7,60,904 6

10,049

Bihar

7,26,026 5

48 4

7,16,317 1

9,661

Telangana

6,68,955 122

3,924 55

6,61,093 176

3,938 1

Assam

6,06,468 205

3,436 46

5,97,082 245

5,950 6

Punjab

6,02,035 27

227 8

5,85,264 16

16,544 3

Jharkhand

3,48,430 7

122 1

3,43,173 8

5,135

Uttarakhand

3,43,756 9

178 1

3,36,181 8

7,397

Jammu And Kashmir

3,31,062 95

843 12

3,25,793 107

4,426

Himachal Pradesh

2,21,437 131

1,303 5

2,16,414 125

3,720 1

Goa

1,77,522 60

604 6

1,73,572 62

3,346 4

Puducherry

1,27,396 52

585 13

1,24,961 64

1,850 1

Manipur

1,22,737 104

1,422 0

1,19,418 102

1,897 2

Mizoram

1,12,848 249

11,633 1,143

1,00,829 1,389

386 3

Tripura

84,321 16

104 4

83,401 12

816

Meghalaya

82,953 55

845 32

80,673 86

1,435 1

Chandigarh

65,302 3

25 3

64,457 6

820

Arunachal Pradesh

54,987 7

140 30

54,567 37

280

Sikkim

31,749 4

174 8

31,184 12

391

Nagaland

31,611 40

248 12

30,689 28

674

Ladakh

20,878 2

36 10

20,634 12

208

Dadra And Nagar Haveli

10,676 1

4 1

10,668

4

Lakshadweep

10,365

0 0

10,314

51

Andaman And Nicobar Islands

7,641

9 0

7,503

129

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