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Table 2 Harm-benefit profile of the Moderna and Pfizer-BioNTech vaccines by sex and age category

From: Increased risk of myocarditis and pericarditis and reduced likelihood of severe clinical outcomes associated with COVID-19 vaccination: a cohort study in Lombardy, Italy

Men receiving the Moderna vaccine

Harms

Age categories

Benefits

No exposurea

Exposurea

Rate differencec

Number needed to harm (95% CI)e

Number needed to treat (95% CI)e

Rate difference

Exposureb

No exposureb

# casesc

Incidence ratec

# casesc

Incidence ratec

Incidence rated

# casesd

Incidence rated

# casesd

12

5.8

1

33.1

27.3

36,680

(10,854 to − 26,596)

12–15 years

20,008

(9980 to − 3,529,828)

50.0

35.0

2

84.9

155

32

16.3

6

154.9

138.6

7213

(3807 to 68,776)

16–19 years

9471

(7513 to 12,852)

105.6

11.2

1

116.8

182

70

14.2

14

94.8

80.6

12,414

(7675 to − 32,468)

20–29 years

6764

(5790 to 8130)

147.9

41.8

16

189.7

693

203

5.9

14

23.7

17.8

56,106

(33,025 to 186,428)

 + 30 years

911

(890 to 933)

1097.7

206.9

389

1304.6

27,939

Women receiving the Moderna vaccine

Harms

Age categories

Benefits

No exposurea

Exposurea

Rate differencec

Number needed to harm (95% CI)e

Number needed to treat

(95% CI)e

Rate difference

Exposureb

No exposureb

# casesc

Incidence ratec

# casesc

Incidence ratec

Incidence rated

# casesd

Incidence rated

# casesd

3

1.5

0

0.0

–

–

12–15 years

27,522

(11,049 to − 56,054)

36.3

38.0

2

74.3

127

8

4.4

1

29.9

25.5

39,184

(11,882 to − 30,193)

16–19 years

7285

(5907 to 9506)

137.3

12.8

1

150.0

216

18

3.9

3

25.2

21.3

46,920

(20,044 to − 137,646)

20–29 years

4279

(3809 to 4980)

233.7

43.9

14

277.6

908

117

3.1

4

6.5

3.3

298,908

(102,754 to − 328,839)

 + 30 years

1,265

(1228 to 1305)

790.2

216.9

454

1007.1

22,328

Men receiving the Pfizer-BioNTech vaccine

Harms

Age categories

Benefits

No exposurea

Exposurea

Rate differencec

Number needed to harm (95% CI)e

Number needed to treat (95% CI)e

Rate difference

Exposureb

No exposureb

# casesc

Incidence ratec

# casesc

Incidence ratec

Incidence rated

# casesd

Incidence rated

# casesd

12

5.8

9

46.4

40.6

24,633

(14,069 to 98,9123)

12–15 years

16,543

(12,395 to 24,863)

60.5

24.5

10

84.9

155

32

16.3

8

36.1

19.7

50,633

(22,046 to − 170,561)

16–19 years

11,741

(9294 to 15,929)

85.2

31.6

18

116.8

182

70

14.2

13

25.4

11.2

89,592

(39,448 to − 330,251)

20–29 years

6,395

(5770 to 7174)

156.4

33.3

49

189.7

693

203

5.9

24

7.0

1.1

890,332

(246,731 to − 553,403)

 + 30 years

925

(910 to 940)

1081.1

223.5

2,556

1304.6

27,939

Women receiving the Pfizer-BioNTech vaccine

Harms

 

Benefits

No exposurea

Exposurea

Rate difference

Number needed to harm (95% CI)e

Age categories

Number needed to treat (95% CI)e

Rate differencec

Exposureb

No exposureb

# casesc

Incidence ratec

# casesc

Incidence ratec

Incidence rated

# casesd

Incidence rated

# casesd

3

1.5

0

0.0

–

–

12–15 years

18,560

(13,691 to 28,810)

53.9

20.4

8

74.3

127

8

4.4

2

9.5

5.1

196,329

(53,937 to − 119,175)

16–19 years

10,413

(8071 to 14,658)

96.0

54.0

30

150.0

216

18

3.9

4

8.3

4.4

227,298

(78,616 to − 254,842)

20–29 years

4254

(3906 to 4668)

235.1

42.5

63

277.6

908

117

3.1

17

4.4

1.3

772,323

(287,274 to − 1,121,831)

 + 30 years

1214

(1192 to 1237)

823.5

183.6

2416

1007.1

22,328

  1. The entire cohort of 9,184,146 vaccine recipients on December 27, 2020 was included in this analysis
  2. aThe observation time for each cohort member was partitioned into two exposure categories to assess the risk of vaccine harm. Starting from the date of administration of each vaccine dose and continuing for 28 days, the exposure period was identified and defined as exposure to the vaccine. The remaining periods (i.e. those uncovered by vaccine exposure) were defined as no exposure to the risk of vaccine harm
  3. bTime of observation for each cohort member was partitioned into two categories of exposure to the benefits of vaccine. The first was from the 14 days after the first vaccine dose and November 30, 2021. The remaining time periods (i.e. those uncovered by vaccine exposure) were defined as no exposure to vaccine protection
  4. cThe first episode of hospital admission with a diagnosis of myocarditis was defined as an outcome event. The incidence rate of myocarditis was calculated as the ratio between the number of outcomes occurring during the period of interest (i.e. exposure or no exposure to the risk of vaccine harm), and the number of person-months accumulating during that period and expressed as the number of cases every million person-months at risk
  5. dThe first episode of hospital admission, including patients in intensive care units, or deaths attributed to COVID-19 was defined as an outcome event. The incidence rate of severe COVID-19 disease was calculated as the ratio between the number of outcomes occurring during the period of interest (i.e. exposure or no exposure to vaccine protection) and the number of person-months accumulating during that period), and expressed as the number of cases per million person-months at risk
  6. eThe upper limit of confidence interval has sometimes negative values. Following Altman [29], a negative value of NNT indicates that the vaccine has a harmful effect, a confidence interval spanning from a positive to a negative value of lower and upper limits, respectively, suggests that the study did not offer statistical evidence that vaccination avoids severe COVID-19 outcomes (i.e. NNT was not significantly different from the null in that sex and age category). Analogously, a negative value of NNH indicates that the vaccine doesn’t have a harmful effect, an interval between lower and upper limits which includes the null, suggests that the study did not offer statistical evidence that the vaccine generates myocarditis (i.e., that NNH was not significantly different from the null in that sex and age category)
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BMC Infectious Diseases

ISSN: 1471-2334

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