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13 October 2020 SARS-Cov-2 Report José Luis Pires

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Page 1: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

13 October 2020SARS-Cov-2 ReportJosé Luis Pires

Page 2: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 2

SARS-Cov-2

➢ Symptoms of COVID-19, Flu and Cold

➢ Confirmed cases by Country

➢ Deaths by Country

➢ Total confirmed Covid-19 cases and deaths per million people

➢ Daily new confirmed Covid-19 cases and deaths per million people

➢ Number of COVID-19 cases reported weekly by WHO region

➢ Portugal

▪ Cases, Deaths and Projections – per week

➢ Ireland

▪ Cases, Deaths and Projections – per week

➢ New Jersey/US

▪ Cases, Deaths and Projections – per week

➢ Recent News

Contents

Page 3: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 3

Symptoms of:

➢ COVID-19

➢ Cold

➢ Flu

Page 4: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 4

Page 5: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 5

Coronavirus (SARS-CoV-2 / Covid-19) – Confirmed cases by countryNote: Selected Countries, sorted by # of cases

3,5823,6433,9086,3669,1199,23112,49915,63916,22020,99322,65224,80527,31733,30439,86243,35157,32657,88464,43687,91390,00190,83898,451

153,761165,880185,378187,138

295,037332,850337,147344,713359,569

620,471776,097

888,968903,730

1,318,7835,103,408

7,175,8807,804,643

0 1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 8,000,000 9,000,000

IcelandThailandEstonia

LithuaniaLuxembo…SloveniaFinlandNorway

MalaysiaCroatiaGreece

KoreaAustraliaDenmarkHungary

IrelandAustria

SingaporeSwitzerland

PortugalJapanChina

SwedenMoroccoBelgiumCanada

NetherlandsIsrael

GermanyTurkey

PhilippinesItalyUK

FranceSpain

ArgentinaRussiaBrazilIndia

US

Last Updated at 13 October 2020, 10:24 AM

by the Center for Systems Science and Engineering

at Johns Hopkins University

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21 August 202028 August 20208 Sep 202015 Sep 202022 Sep 202029 Sep 20206 Oct 202013 Oct 2020

Page 6: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 6

Coronavirus (SARS-CoV-2 / Covid-19) – Deaths by CountryNote: Selected Countries, sorted by # of cases

215,089

109,856

150,689

22,83424,186

33,12432,703

42,96536,205

6,3728,8959,6402,021

6,6549,68010,2112,6365,8944,7391,6332,0942,097 28 861 1,827 996 671 899 434 456 330 159 276 346 173 128 106 68 59 10

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100,000

150,000

200,000

250,000

Source: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

Last Updated at 13 October 2020, 10:24 AM

by the Center for Systems Science and Engineering

at Johns Hopkins University

Page 7: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 7

Total confirmed Covid-19 cases per million people

Page 8: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 8

Daily infections vs mortality per million

Page 9: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 9

Daily deaths of

patients diagnosed

with coronavirus

(7-day average)

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Page 10: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 10

Number of COVID-19 cases reported weekly by WHO Region, and global

deaths, 30 December 2019 through 11 October 2020

Source: WHO

Page 11: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 11

Number of COVID-19 cases reported weekly by WHO Region, and global

deaths, 30 December 2019 through 04 October 2020

Africa South-East AsiaWestern Pacific

Eastern MediterraneanEuropeAmerica

Page 12: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Portugal

Page 13: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 15

Covid-19 Projections – Portugal – Daily Deaths

Source: Institute for Health Metrics and Evaluation / University of Washington - https://covid19.healthdata.org/portugal?view=daily-deaths&tab=trend

Projection

Daily Deaths

1 February 2021

Projected: 91

Projections in:

• 18 September: 132

• 24 September: 106

• 2 October: 172

• 9 October: 91

Today

12 Oct 2020

14 deaths

Jan 2021

Feb 2021

Page 14: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 16

Covid-19 Projections – Portugal – Total Deaths

Source: Institute for Health Metrics and Evaluation / University of Washington - https://covid19.healthdata.org/portugal?view=daily-deaths&tab=trend

Projection

Total Deaths

1 February 2021

Projected: 7,067

Projections in:

• 18 September: 8,698

• 24 September: 11,352

• 2 October: 8,386

• 9 October: 7,067

Today

12 Oct 2020

2,094 deaths

Jan 2021

Feb 2021

Page 15: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 17

Covid-19 Projections – Portugal – Daily Infections

Source: Institute for Health Metrics and Evaluation / University of Washington - https://covid19.healthdata.org/portugal?view=daily-deaths&tab=trend

Projection

Daily Infections

1 February 2021

Projected: 4,994

Projections in:

• 18 September: 5,478

• 24 September: 6,292

• 2 October: 9,498

• 9 October: 4,994

Jan 2021

Feb 2021

Today

12 Oct 2020

1,249 infections

Page 16: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 20

Coronavirus (SARS-CoV-2 / COVID 19) – Portugal – New cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

30 2

15

1,3

55

4,3

62

5,3

16

5,3

07

3,6

21

3,4

67

1,6

09 2

,29

9

1,4

55

1,5

87

1,8

77

2,1

93

1,9

97

2,4

43

2,5

13

2,2

51

2,6

15

2,1

24

1,5

28

1,2

99

1,2

05

1,4

34

1,4

95 2

,17

1

2,4

90

3,7

25

4,5

94

5,0

27 5,5

47

7,5

13

Total Cases in Portugal: 87,913

2020.10.12

10 October: Portugal reported 1,646 cases

Page 17: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 21

Coronavirus (SARS-CoV-2 / COVID 19) – Portugal – Hospital stable/ICU per

week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

10

86 1

39

30

4

88

3

11

71 12

42

11

05

92

6

82

8

69

5

59

1

51

2

43

0

41

1

42

2

44

1 49

7

48

8

46

2

42

8

39

4

37

5

35

1

32

7

32

5

34

4 40

9 48

4

58

5

67

1

78

3

Average # of Patients stable in the Hospital per week

0 3

25

73

22

6

24

5

21

7

19

9

16

2

13

0

11

0

90

67

58 6

9

69 71 74

71

66

56

42

39

37 40

40 42

54 6

1

79

10

4 11

4

Average # of Patients in the ICU per week

Total Patients in the Hospital: 877

2020.10.12

Total Patients in the ICU: 128

2020.10.12

Page 18: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 22

Coronavirus (SARS-CoV-2 / COVID 19) – Portugal – New Active cases per

week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

30 2

13

1,3

38

4,2

19

5,1

08

4,8

96

3,0

78

2,7

50

918 1

,34

7

-715

-77

538

285

-277

789

450

479

-367

-348

-489

-340

226

400

1,0

37

1,4

01

2,5

82

3,0

22

2,9

35

2,9

35

4,4

58Active Cases in Portugal: 32,321

2020.10.12

Page 19: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 23

Coronavirus (SARS-CoV-2 / COVID 19) – Portugal – New deaths/recoveries

per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

0 0

14

105

176

209

210

189

140

92

83

98

94

69

38

13

34

50

46

29

28

21

18 22

18 23

21 2

7

45

41

52

75

# of deaths per week

0 2 3 38

32

202 333

719

360

860

2,0

87

2,1

00

1,8

60

1,5

86

1,6

74

2,7

07

1,6

90 1,9

51

1,8

90

2,4

62

1,8

48

1,7

67

1,5

27

1,1

86

1,0

77

1,1

11

1,0

68

1,1

16

1,5

27

2,0

51

2,5

60

2,9

80

# of recoveries per week

Total Deaths: 2,094

2020.10.12

Total Recoveries: 53,498

2020.10.12

Page 20: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 24

Coronavirus

(SARS-CoV-2 / COVID 19)

Portugal

12 October 2020

Page 21: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 25

Coronavirus (SARS-CoV-2 / COVID 19) ) – Loures - New cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

0 0

40

66

66

61

58

93 97 1

07

207 2

24

166

227

187

168

119

178

109

87

74

55

44 46

36

73

147

154

179

265

237

Total Cases in Loures: 3,594

2020.10.12

Page 22: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 26

Coronavirus (SARS-CoV-2 / COVID 19) ) – Lisbon - New cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

0 0

419

215

209

148

368

161

168 203 2

39

223

214 238 2

83

288

222

439

156

168

154

129

131

122 143

208

307

448

467

448 4

95

Total Cases in Lisbon: 7,460

2020.10.12

Page 23: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 27

Coronavirus (SARS-CoV-2 / COVID 19) ) – Lisbon and Tagus Valley - New

cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

5

110

418

944

1,4

26

937

659

1,0

31

516

1,1

95

993 1

,18

8

1,7

19

1,9

31

1,7

55

1,9

34

1,9

90

1,7

75 2,0

84

1,6

50

1,1

87

875

787

821

822 1

,03

1

1,1

79

1,7

69

2,2

72 2

,62

4

2,6

16 2,8

97

Total Cases in Lisbon and Tagus Valley: 43,646

2020.10.12

Page 24: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 28

Coronavirus (SARS-CoV-2 / COVID 19) – % of new cases in Lisbon and Tagus

Valley - New cases per week

30215

1,355

4,362

5,316 5,307

3,6213,467

1,609

2,299

1,4551,587

1,877

2,1931,997

2,443 2,513

2,251

2,615

2,124

1,5281,299 1,205

1,434 1,495

2,171

2,490

3,725

4,594

5,027

5,547

7,513

5 110

418

944

1,426

937

659

1,031

516

1,195993

1,188

1,7191,931

1,7551,934 1,990

1,775

2,084

1,650

1,187

875 787 821 8221,031

1,179

1,769

2,272

2,624 2,616

2,897

17%

51%

31%

22%

27%

18% 18%

30%32%

52%

68%

75%

92%88% 88%

79% 79% 79% 80%78% 78%

67%65%

57%55%

47% 47% 47%49%

52%

47%

39%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0

1000

2000

3000

4000

5000

6000

7000

8000

2 Mar -8 Mar

9 Mar -15 Mar

16 Mar -22 Mar

23 Mar -29 Mar

30 Mar -5 Apr

6 Apr -12 Apr

13 Apr -19 Apr

20 Apr -26 Apr

27 Apr -3 May

4 May -10 May

11 May- 17May

18 May- 24May

25 May- 31May

1 Jun -7 Jun

8 Jun -14 Jun

15 Jun -21 Jun

22 Jun -28 Jun

29 Jun -5 Jul

6 Jul -12 jul

13 Jul -19 Jul

20 Jul -26 Jul

27 Jul -2 Aug

3 Aug -9 Aug

10 Aug -16 Aug

17 Aug -23 Aug

24 Aug -30 Aug

31 Aug -6 Sep

7 Ssep -13 Sep

14 Sep -20 Sep

21 Sep -27 Sep

28 Sep -4 Oct

5 Oct -11 Oct

Portugal LVT %

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

Page 25: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 29

Portugal Loures

LisbonLisbon and Tagus Valley

SARS-CoV-2 / COVID 19 - New cases per week

30 21

5

1,3

55

4,3

62 5,3

16

5,3

07

3,6

21

3,4

67

1,6

09

2,2

99

1,4

55

1,5

87

1,8

77

2,1

93

1,9

97

2,4

43

2,5

13

2,2

51

2,6

15

2,1

24

1,5

28

1,2

99

1,2

05

1,4

34

1,4

95

2,1

71

2,4

90 3

,72

5 4,5

94

5,0

27

5,5

47 7

,51

3

0 0

40

66

66

61

58

93 97 10

7

20

7 22

4

16

6

22

7

18

7

16

8

11

9

17

8

10

9

87

74

55

44 46

36

73

14

7

15

4 17

9

17

9

26

5

23

7

5 11

0 41

8

94

4

1,4

26

93

7

65

9

1,0

31

51

6

1,1

95

99

3 1,1

88 1

,71

9

1,9

31

1,7

55

1,9

34

1,9

90

1,7

75

2,0

84

1,6

50

1,1

87

87

5

78

7

82

1

82

2 1,0

31

1,1

79

1,7

69 2

,27

2 2,6

24

2,6

16

2,8

97

0 0

41

9

21

5

20

9

14

8

36

8

16

1

16

8 20

3 23

9

22

3

21

4

23

8 28

3

28

8

22

2

43

9

15

6

16

8

15

4

12

9

13

1

12

2

14

3 20

8

30

7

44

8

46

7

44

8 49

5

Page 26: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Ireland

Page 27: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 32

Coronavirus (SARS-CoV-2 / COVID 19) ) – Ireland - New cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

20 1

48

737

1,7

09

2,3

79

3,0

43

4,0

33

4,0

11

2,2

44

1,4

90

1,1

16

527

379

249

112

97

65 94 127

143

122 286 5

50

557 732

707 921

1,3

14

1,9

82

2,0

84

3,0

71

4,5

10Total Cases in Ireland: 42,528

2020.10.11

Page 28: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 33

Coronavirus (SARS-CoV-2 / COVID 19) ) – Cork - New cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

0 0 0

107

135

305

380

82

54

43

145

76

49 52

4 2 0 5 5 9 9 3 9 12 17 2

9

12 2

2

45

184

296

391Total Cases in Cork: 2,583

2020.10.09

Page 29: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

New Jersey

Page 30: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 36

Coronavirus (SARS-CoV-2 / COVID 19) ) – New Jersey - New cases per week

Source: https://covid19.min-saude.pt/ponto-de-situacao-atual-em-portugal/

6 92

1,8

16

11,4

72

24,6

64

24,7

83

24,2

78

23,7

37

17,7

06

11,7

88

7,8

02

7,8

20

6,2

91

3,7

19

2,7

17

2,2

61

2,0

40

2,2

20

1,8

96

1,5

16

2,5

80

2,9

87

2,4

23

2,6

82

2,0

39

2,1

17

2,4

47

2,5

76

3,1

28

3,7

86

4,6

54

5,4

26

Total Cases in New Jersey: 213,628

2020.10.11

Page 31: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Recent News

Page 32: José Luis Pires SARS-Cov-2 Report 13 October 2020 · 2 days ago  · Morocco Belgium Canada Netherlands Israel Germany Turkey Philippines Italy UK France Spain Argentina Russia Brazil

Confidential Hovione © 2020October 2020 39

• 13 October

• Johnson & Johnson has announced the temporary pause of further dosing in all its vaccine candidate clinical trials for Covid-19 after one of the study participants reported an unexplained

illness. The ENSEMBLE trial's independent Data Safety Monitoring Board (DSMB) and the company’s internal clinical and safety physicians are currently reviewing and evaluating the

participant’s illness.

• 12 October

• AstraZeneca has received an investment of approximately $486m from the US Government to develop and supply its long-acting antibody (LAAB) cocktail, AZD7442, for Covid-19 treatment.

The company intends to supply up to 100,000 doses of the therapy beginning towards the end of 2020. In the coming weeks, AZD7442 will progress into two Phase III trials in a total of over

6,000 subjects enrolled at sites across the US and other countries.

• UK researchers are conducting a clinical trial to test the Bacillus Calmette-Guérin (BCG) vaccine, which is currently used to protect babies from tuberculosis, for its ability to protect against

Covid-19. The UK arm of the large-scale, global study is being led by the University of Exeter. Named BRACE, the trial will involve more than 10,000 healthcare staff and care home workers

across the UK, Australia, the Netherlands, Spain, and Brazil.

• Gilead Sciences has reported final results from the Phase III ACTT-1 clinical trial, where its experimental antiviral Veklury (remdesivir) demonstrated consistent, clinically meaningful

improvements when compared to placebo, in hospitalised adults with mild-moderate or severe Covid-19. Data showed that treatment with the drug led to a faster time to recovery.

• 8 October

• Eli Lilly has submitted an application to the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for LY-CoV555 monotherapy for treating higher-risk patients

with mild-to-moderate Covid-19. The company also plans to submit an EUA application to the FDA for a combination therapy of LY-CoV555 and LY-CoV016 in November this year.

• US-based biotechnology company Moderna may seek an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 vaccine candidate after 25

November. With the EUA, the FDA can authorise the use of unapproved medical products or treatments during public health emergencies.

The latest coronavirus updates and developments impacting the global

pharmaceutical supply chain…

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• 6 October

• The FDA said it has worked to make clear to Covid-19 vaccine developers what standards would have to be met to authorize use of shots. One such path is an emergency-use authorization,

or EUA, a fast-track procedure that relies on less safety and efficacy data than a full approval.

• NVIDIA is creating a supercomputer named Cambridge-1 to enable artificial intelligence (AI)-based research on Covid-19, as well as other healthcare areas. Claimed to be the UK’s most

powerful supercomputer, Cambridge-1 will be initially leveraged by GlaxoSmithKline, AstraZeneca, Guy’s and St Thomas’ NHS Foundation Trust, King’s College London and Oxford

Nanopore Technologies for pharmaceutical research.

• 1 October

• European regulators are set to start an accelerated review of a Covid-19 vaccine front-runner from the University of Oxford and AstraZeneca Plc. Trials were halted earlier this month due to

concerns about a trial participant who fell ill. However Reuters also reported that the US Food and Drug Administration had widened its investigation of the incident that led to the trial halt. US

authorities have yet to approve the restart of the trial there.

• Pfizer and BioNTech have started enrolling participants into a Phase III clinical trial of their Covid-19 vaccine candidate in South Africa. Designed to assess the safety and efficacy of the

vaccine candidate, the trial will involve nearly 800 subjects at four sites across Gauteng, Limpopo and the Western Cape. The South African Health Products Regulatory Authority (Sahpra)

granted approval for the trial on 22 September 2020.

• 30 September

• World Bank president David Malpass has said that the bank is seeking board approval for a $12bn Covid-19 vaccine financing plan to ensure enough vaccine doses are available for poor

and developing countries. In an exclusive interview with Reuters, Malpass added that the plan is to help these countries obtain and distribute vaccines early to healthcare and other essential

workers, as well as boost manufacturing worldwide.

• Moderna has reported data from the second interim analysis of Phase I clinical trial of its Covid-19 vaccine candidate, mRNA-1273, which was found to be generally well-tolerated at 25µg

and 100µg dose levels in participants aged 56-70 and above 71 years. Immune responses were found to be dose-dependent, with the 100µg dose demonstrating higher binding and

neutralising antibody titres.

The latest coronavirus updates and developments impacting the global

pharmaceutical supply chain… (cont.)

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• 29 September

• The FDA has placed partial clinical hold on Inovio Pharmaceuticals‘ planned Phase II/III clinical trial of its potential Covid-19 vaccine, INO-4800. The regulator asked the company to provide

more information on the trial, including details about the use of CELLECTRA 2000 delivery device. Inovio would respond to FDA’s queries in October, after which the agency will have up to

30 days to decide whether the trial may proceed.

• 28 September

• Ireland recorded 430 new infections on Sunday, the most in five months, with Dublin accounting for around half the cases.

• Industrial companies in China registered profits for the fourth straight month in August although the growth is lower than that of 2020.

• Despite the growth, the recovery of China from the impact of the Covid-19 pandemic remains uneven, with industrial production growing by 5.6% in August compared to the previously year.

• Johnson & Johnson (J&J) subsidiary Janssen has reported positive interim data from an ongoing Phase I/IIa clinical trial of a potential Covid-19 vaccine, JNJ-78436735. According to the

results, a single dose of the vaccine candidate showed a strong neutralising antibody response in almost all participants aged 18 years and above.

• 25 September

• The virus is continuing to mutate throughout the course of the pandemic, according to new research, with experts believing it is probably becoming more contagious. The study did not find

that mutations of the virus had made it more lethal or changed its effects.

• Ireland’s government moved to tighten restrictions in a second county and signalled more limits may follow. Travel to and from Donegal in the north-west of the country will be limited, while

restaurants will be restricted to outdoor service only. That mirrors restrictions placed on Dublin six days ago.

• US-based biotechnology firm Novavax has started the first Phase III clinical trial of its potential Covid-19 vaccine, NVX-CoV2373, in the UK. Performed with the UK Government’s Vaccines

Taskforce, the trial will investigate the safety, efficacy and immunogenicity of NVX-CoV2373. The study is designed to recruit up to 10,000 participants aged 18 to 84 years, with and without

relevant comorbidities, over the coming four to six weeks.

• The US FDA is yet to provide authorisation for AstraZeneca to resume its Covid-19 vaccine trial in the country, nearly three weeks following a pause over safety concerns. The US regulators

are still investigating an illness in one of the trial participants, even after the clinical programme restarted in the UK and other countries, according to Reuters.

• 23 September

• Fujifilm Toyama Chemical has reported that the Phase III clinical trial of Avigan (favipiravir) has met its primary endpoint of time to negative conversion of detectable SARS-CoV 2 viral RNA

in the RT-PCR assays, and to relief of symptoms, in Covid-19 patients with non-severe pneumonia in Japan. Based on the positive data, the company plans to seek approval for the drug to

treat Covid-19, expanding its current indication for influenza patients.

The latest coronavirus updates and developments impacting the global

pharmaceutical supply chain… (cont.)

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• 22 September

• An $18 billion initiative to deploy a Covid-19 vaccine around the world is moving into the next phase, with 156 countries and regions joining the program.

• Countries across Europe including the UK, Spain and France are witnessing a surge in the number of Covid-19 cases.

• Some of these countries have just started showing signs of economic revival and new lockdowns to control the recent surge in cases may have serious consequences.

• Meanwhile, the epidemic in the UK appears to be doubling every seven days, according to the government’s chief scientific advisor.

• More than 150 countries, including 64 higher income and 92 low- and middle-income economies, have joined the World Health Organization (WHO), Gavi, the Vaccine Alliance and Coalition

for Epidemic Preparedness Innovations of COVAX Facility, which aims for equitable distribution of Covid-19 vaccines. However, China and the US are missing from the list of members.

COVAX Facility intends to begin signing agreements with vaccine manufacturers and developers to potentially secure two billion doses by the end of next year.

• 21 September

• Russia has granted marketing authorisation for R-Pharm’s Covid-19 prescription drug, Coronavir, to treat outpatients with mild to moderate infection. The antiviral drug has become the first

coronavirus drug to be rolled out in pharmacies in Russia.

• Sanofi and GlaxoSmithKline (GSK) have signed an advanced purchase agreement with the European Commission (EC) to supply up to 300 million doses of their potential Covid-19 vaccine,

following regulatory approval.

• The European Medicines Agency‘s human medicines committee (CHMP) has recommended that dexamethasone can be considered a treatment option for adult and adolescent Covid-19

patients needing oxygen therapy.

• 18 September

• Moderna plans to seek emergency authorisation for the use of its Covid-19 vaccine in high-risk groups, if the vaccine shows at least 70% effectiveness, said Reuters citing the company’s

chief executive. The vaccine candidate is currently in Phase III trial, which enrolled 25,296 participants so far. An interim analysis is expected to take place in October or November.

The latest coronavirus updates and developments impacting the global

pharmaceutical supply chain… (cont.)

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• https://en.wikipedia.org/wiki/Timeline_of_the_2019%E2%80%9320_Wuhan_coronavirus_outbreak

• https://www.seattletimes.com/seattle-news/health/coronavirus-timeline-how-the-outbreak-unfolded/

• https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

• https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports

• https://www.pharmaceutical-technology.com/news/coronavirus-a-timeline-of-how-the-deadly-outbreak-evolved/

• https://www.cphi-online.com/updated-covid19-pharma-tracker-news082415.html

• https://www.dgs.pt/em-destaque.aspx

Sources