Vaccine Information: Moderna COVID-19 Vaccine (Page 3 of 6)

5.2 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.

5.3 Limitations of Vaccine Effectiveness

The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multi-inflammatory Syndrome (MIS) in adults, and hospitalized or fatal cases of COVID-19 following vaccination with the Moderna COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to ModernaTX, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and ModernaTX, Inc.

In clinical studies, the adverse reactions in participants 18 years of age and older were pain at the injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site (14.7%), and erythema at the injection site (10.0%).

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Overall, 15,419 participants aged 18 years and older received at least one dose of Moderna COVID- 19 Vaccine in three clinical trials (NCT04283461, NCT04405076, and NCT04470427).

The safety of Moderna COVID-19 Vaccine was evaluated in an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,351 participants 18 years of age and older who received at least one dose of Moderna COVID-19 Vaccine (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18 to 64 years of age and 7,520 (24.8%) of participants were 65 years of age and older. Overall, 52.7% were male, 47.3% were female, 20.5% were Hispanic or Latino, 79.2% were White,10.2% were African American, 4.6% were Asian, 0.8% were American Indian or Alaska Native, 0.2% were Native Hawaiian or Pacific Islander, 2.1% were Other, and 2.1% were Multiracial. Demographic characteristics were similar among participants who received Moderna COVID-19 Vaccine and those who received placebo.

Solicited Adverse Reactions

Data on solicited local and systemic adverse reactions and use of antipyretic medication were collected using standardized diary cards for 7 days following each injection (i.e., day of vaccination and the next 6 days) among participants receiving Moderna COVID-19 Vaccine (n=15,179) and participants receiving placebo (n=15,163) with at least 1 documented dose. Solicited adverse reactions were reported more frequently among vaccine participants than placebo participants.

The reported number and percentage of the solicited local and systemic adverse reactions by age group and dose by subject are presented in Table 1 and Table 2, respectively.

Table 1: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Within 7 Days* After Each Dose in Participants 18-64 Years (Solicited Safety Set, Dose 1 and Dose 2)
Moderna COVID-19 Vaccine Placebo a
Dose 1 (N=11,406) n (%) Dose 2 (N=10,985) n (%) Dose 1 (N=11,407) n (%) Dose 2 (N=10,918) n (%)
* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary). a Placebo was a saline solution. b Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily activity. c Grade 3 swelling and erythema: Defined as >100 mm / >10 cm. d Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity. e Grade 4 fatigue, arthralgia: Defined as requires emergency room visit or hospitalization. f Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity. g Grade 3 chills: Defined as prevents daily activity and requires medical intervention. h Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration. i Grade 3 fever: Defined as ≥39.0 – ≤40.0°C / ≥102.1 – ≤104.0°F. j Grade 4 fever: Defined as >40.0°C / >104.0°F.

Local Adverse Reactions

Pain

9,908

(86.9)

9,873

(89.9)

2,177

(19.1)

2,040

(18.7)

Pain, Grade 3 b

366

(3.2)

506

(4.6)

23

(0.2)

22

(0.2)

Axillary swelling/tenderness

1,322

(11.6)

1,775

(16.2)

567

(5.0)

470

(4.3)

Axillary swelling/tenderness, Grade 3 b

37

(0.3)

46

(0.4)

13

(0.1)

11

(0.1)

Swelling (hardness)

≥25 mm

767

(6.7)

1,389

(12.6)

34

(0.3)

36

(0.3)

Swelling (hardness), Grade 3 c

62

(0.5)

182

(1.7)

3

(<0.1)

4

(<0.1)

Erythema (redness)

≥25 mm

344

(3.0)

982

(8.9)

47

(0.4)

43

(0.4)

Erythema (redness), Grade 3 c

34

(0.3)

210

(1.9)

11

(<0.1)

12

(0.1)

Systemic Adverse Reactions

Fatigue

4,384

(38.4)

7,430

(67.6)

3,282

(28.8)

2,687

(24.6)

Fatigue, Grade 3 d

120

(1.1)

1,174

(10.7)

83

(0.7)

86

(0.8)

Fatigue, Grade 4 e

1

(<0.1)

0

(0)

0

(0)

0

(0)

Headache

4,030

(35.3)

6,898

(62.8)

3,304

(29.0)

2,760

(25.3)

Headache, Grade 3 f

219

(1.9)

553

(5.0)

162

(1.4)

129

(1.2)

Myalgia

2,699

(23.7)

6,769

(61.6)

1,628

(14.3)

1,411

(12.9)

Myalgia, Grade 3 d

73

(0.6)

1,113

(10.1)

38

(0.3)

42

(0.4)

Arthralgia

1,893

(16.6)

4,993

(45.5)

1,327

(11.6)

1,172

(10.7)

Arthralgia, Grade 3 d

47

(0.4)

647

(5.9)

29

(0.3)

37

(0.3)

Arthralgia, Grade 4 e

1

(<0.1)

0

(0)

0

(0)

0

(0)

Chills

1,051

(9.2)

5,341

(48.6)

730

(6.4)

658

(6.0)

Chills, Grade 3 g

17

(0.1)

164

(1.5)

8

(<0.1)

15

(0.1)

Nausea/vomiting

1,068

(9.4)

2,348

(21.4)

908

(8.0)

801

(7.3)

Nausea/vomiting,

Grade 3 h

6

(<0.1)

10

(<0.1)

8

(<0.1)

8

(<0.1)

Fever

105

(0.9)

1,908

(17.4)

37

(0.3)

39

(0.4)

Fever, Grade 3 i

10

(<0.1)

184

(1.7)

1

(<0.1)

2

(<0.1)

Fever, Grade 4 j

4

(<0.1)

12

(0.1)

4

(<0.1)

2

(<0.1)

Use of antipyretic or pain medication

2,656

(23.3)

6,292

(57.3)

1,523

(13.4)

1,248

(11.4)

Table 2: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Within 7 Days* After Each Dose in Participants 65 Years and Older (Solicited Safety Set, Dose 1 and Dose 2)
Moderna COVID-19 Vaccine Placebo a
Dose 1 (N=3,762) n (%) Dose 2 (N=3,692) n (%) Dose 1 (N=3,748) n (%) Dose 2 (N=3,648) n (%)
* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary). a Placebo was a saline solution. b Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily activity. c Grade 3 swelling and erythema: Defined as >100 mm / >10 cm. d Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity. e Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity. f Grade 3 chills: Defined as prevents daily activity and requires medical intervention. g Grade 3 Nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration. h Grade 4 Nausea/vomiting: Defined as requires emergency room visit or hospitalization for hypotensive shock. i Grade 3 fever: Defined as ≥39.0 – ≤40.0°C / ≥102.1 – ≤104.0°F. j Grade 4 fever: Defined as >40.0°C / >104.0°F.

Local Adverse Reactions

Pain

2,782

(74.0)

3,070

(83.2)

481

(12.8)

437

(12.0)

Pain, Grade 3 b

50

(1.3)

98

(2.7)

32

(0.9)

18

(0.5)

Axillary swelling/tenderness

231

(6.1)

315

(8.5)

155

(4.1)

97

(2.7)

Axillary swelling/tenderness, Grade 3 b

12

(0.3)

21

(0.6)

14

(0.4)

8

(0.2)

Swelling (hardness)

≥25 mm

165

(4.4)

400

(10.8)

18

(0.5)

13

(0.4)

Swelling (hardness), Grade 3 c

20

(0.5)

72

(2.0)

3

(<0.1)

7

(0.2)

Erythema (redness)

≥25 mm

86

(2.3)

275

(7.5)

20

(0.5)

13

(0.4)

Erythema (redness), Grade 3 c

8

(0.2)

77

(2.1)

2

(<0.1)

3

(<0.1)

Systemic Adverse Reactions

Fatigue

1,251

(33.3)

2,152

(58.3)

851

(22.7)

716

(19.6)

Fatigue, Grade 3 d

30

(0.8)

254

(6.9)

22

(0.6)

20

(0.5)

Headache

921

(24.5)

1,704

(46.2)

723

(19.3)

650

(17.8)

Headache, Grade 3 e

52

(1.4)

106

(2.9)

34

(0.9)

33

(0.9)

Myalgia

742

(19.7)

1,739

(47.1)

443

(11.8)

398

(10.9)

Myalgia, Grade 3 d

17

(0.5)

205

(5.6)

9

(0.2)

10

(0.3)

Arthralgia

618

(16.4)

1,291

(35.0)

456

(12.2)

397

(10.9)

Arthralgia, Grade 3 d

13

(0.3)

123

(3.3)

8

(0.2)

7

(0.2)

Chills

202

(5.4)

1,141

(30.9)

148

(4.0)

151

(4.1)

Chills, Grade 3 f

7

(0.2)

27

(0.7)

6

(0.2)

2

(<0.1)

Nausea/vomiting

194

(5.2)

437

(11.8)

166

(4.4)

133

(3.6)

Nausea/vomiting,

Grade 3 g

4

(0.1)

10

(0.3)

4

(0.1)

3

(<0.1)

Nausea/vomiting,

Grade 4 h

0

(0)

1

(<0.1)

0

(0)

0

(0)

Fever

10

(0.3)

370

(10.0)

7

(0.2)

4

(0.1)

Fever, Grade 3 i

1

(<0.1)

18

(0.5)

1

(<0.1)

0

(0)

Fever, Grade 4 j

0

(0)

1

(<0.1)

2

(<0.1)

1

(<0.1)

Use of antipyretic or pain medication

673

(17.9)

1,546

(41.9)

477

(12.7)

329

(9.0)

Solicited local and systemic adverse reactions reported following administration of Moderna COVID-19 Vaccine had a median duration of 2 to 3 days.

Grade 3 solicited local adverse reactions were more frequently reported after Dose 2 than Dose 1. Solicited systemic adverse reactions were more frequently reported by vaccine recipients after Dose 2 than after Dose 1.

Unsolicited Adverse Events

Participants were monitored for unsolicited adverse events for up to 28 days following each dose and follow-up is ongoing. Serious adverse events and medically attended adverse events will be recorded for the entire study duration of 2 years. As of November 25, 2020, among participants who had received at least 1 dose of vaccine or placebo (vaccine=15,185, placebo=15,166), unsolicited adverse events that occurred within 28 days following each vaccination were reported by 23.9% of participants (n=3,632) who received Moderna COVID-19 Vaccine and 21.6% of participants (n=3,277) who received placebo. In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2.

Lymphadenopathy-related events that were not necessarily captured in the 7-day e-Diary were reported by 1.1% of vaccine recipients and 0.6% of placebo recipients. These events included lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy, injection-site lymphadenopathy, and axillary mass, which were plausibly related to vaccination. This imbalance is consistent with the imbalance observed for solicited axillary swelling/tenderness in the injected arm.

Hypersensitivity adverse events were reported in 1.5% of vaccine recipients and 1.1% of placebo recipients. Hypersensitivity events in the vaccine group included injection site rash and injection site urticaria, which are likely related to vaccination.

Throughout the same period, there were three reports of Bell’s palsy in the Moderna COVID-19 Vaccine group (one of which was a serious adverse event), which occurred 22, 28, and 32 days after vaccination, and one in the placebo group which occurred 17 days after vaccination. Currently available information on Bell’s palsy is insufficient to determine a causal relationship with the vaccine.

There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events (including other neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of November 25, 2020, serious adverse events were reported by 1.0% (n=147) of participants who received Moderna COVID-19 Vaccine and 1.0% (n=153) of participants who received placebo, one of which was the case of Bell’s palsy which occurred 32 days following receipt of vaccine.

In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was 9 weeks after Dose 2.

There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of dermatological fillers. The onset of swelling was reported 1 and 2 days, respectively, after vaccination and was likely related to vaccination.

There was one serious adverse event of intractable nausea and vomiting in a participant with prior history of severe headache and nausea requiring hospitalization. This event occurred 1 day after vaccination and was likely related to vaccination.

There were no other notable patterns or imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.