Vaccine Information: Moderna COVID-19 Vaccine (Page 4 of 8)

5.3 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

5.4 Altered Immunocompetence

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

5.5 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 myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Moderna COVID-19 Vaccine.6 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 a clinical study, the adverse reactions in individuals 6 years through 11 years of age following administration of the primary series were pain at the injection site (98.4%), fatigue (73.1%), headache (62.1%), myalgia (35.3%), chills (34.6%), nausea/vomiting (29.3%), axillary swelling/tenderness (27.0%), fever (25.7%), erythema at the injection site (24.0%), swelling at the injection site (22.3%), and arthralgia (21.3%).

Post-Authorization Experience

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine outside of clinical trials.


6
Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

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, approximately 39,000 participants aged 6 months and older received at least one dose of Moderna COVID-19 Vaccine in five clinical trials (NCT04283461, NCT04405076, NCT04470427, NCT04649151, and NCT04796896). In a sixth clinical trial (NCT04885907), 60 solid organ transplant recipients received a third dose of Moderna COVID-19 Vaccine.

Study 1 (NCT04470427) is a Phase 3 randomized, placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,346 participants 18 years of age and older who received at least one dose of Moderna COVID-19 Vaccine 7 (n=15,184) or placebo (n=15,162). Study 3 (NCT04649151) is a Phase 2/3 randomized, placebo-controlled, observer-blind, clinical trial conducted in the United States involving 3,726 participants 12 years through 17 years of age who received at least one dose of Moderna COVID-19 Vaccine (n=2,486) or placebo (n=1,240). Study 4 (NCT04796896) includes an ongoing Phase 2/3 randomized, placebo-controlled, observer-blind clinical trial component conducted in the United States and Canada involving 10,390 participants 6 months through 11 years of age who received at least one dose of Moderna COVID-19 Vaccine (n=7,799) or placebo (n=2,591).

Individuals 6 Years Through 11 Years of Age

Safety data for Moderna COVID-19 Vaccine from the ongoing Phase 2/3 randomized, placebo-controlled, observer-blind, clinical trial conducted in the United States and Canada included data in 4,002 participants 6 years through 11 years of age who received at least one dose of Moderna COVID-19 Vaccine (n=3,007) or placebo (n=995) (Study 4). As of the data cutoff date of November 10, 2021, the median duration of blinded follow-up for safety was 51 days after Dose 2, and 1,284 participants had been followed for at least 2 months after Dose 2 (vaccine=1,006, placebo=218).

Demographic characteristics in Study 4 were similar among participants who received Moderna COVID-19 Vaccine and those who received placebo. Overall, 50.8% were male, 49.2% were female, 18.5% were Hispanic or Latino, 65.6% were White, 10.0% were African American, 9.9% were Asian, 0.4% were American Indian or Alaska Native, <0.1% were Native Hawaiian or Pacific Islander, 2.1% were other races, and 10.6% were Multiracial.

Solicited Adverse Reactions

Local and systemic adverse reactions and use of antipyretic medication were solicited in an electronic diary for 7 days following each injection (i.e., day of vaccination and the next 6 days) among participants receiving Moderna COVID-19 Vaccine (n=3,006) and participants receiving placebo (n=994) with at least 1 documented dose. Events that persisted for more than 7 days were followed until resolution.

The reported number and percentage of the solicited local and systemic adverse reactions in participants 6 years through 11 years of age by dose in Study 4 are presented in Table 1.

Table 1: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Starting Within 7 Days* After Each Dose in Participants 6 Years Through 11 Years (Solicited Safety Set, Dose 1 and Dose 2)
Moderna COVID-19 Vaccine Placeboa
Dose 1 (N=3,004)n (%) Dose 2 (N=2,988)n (%) Dose 1 (N=993)n (%) Dose 2 (N=969)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). † No Grade 4 adverse reactions were reported.a Placebo was a saline solution. b Grade 3 pain, axillary swelling/tenderness, nausea/vomiting: Defined as prevents daily activity.c Grade 3 fatigue, headache, myalgia, arthralgia: Defined as significant; prevents daily activity. d Grade 3 chills: Defined as prevents daily activity and requires medical intervention.

Local Adverse Reactions

Pain

2,796

(93.1)

2,832

(94.8)

465

(46.8)

480

(49.5)

Pain, Grade 3b

28

(0.9)

81

(2.7)

0

(0)

2

(0.2)

Axillary swelling/tenderness

465

(15.5)

537

(18.0)

84

(8.5)

65

(6.7)

Axillary swelling/tenderness, Grade 3b

3

(<0.1)

3

(0.1)

1

(0.1)

2

(0.2)

Swelling (hardness)

≥25 mm

354

(11.8)

507

(17.0)

12

(1.2)

12

(1.2)

Swelling (hardness), Grade 3: >100 mm

19

(0.6)

20

(0.7)

1

(0.1)

0

(0)

Erythema (redness)

≥25 mm

349

(11.6)

559

(18.7)

13

(1.3)

10

(1.0)

Erythema (redness), Grade 3: >100 mm

16

(0.5)

33

(1.1)

1

(0.1)

1

(0.1)

Systemic Adverse Reactions

Fatigue

1,298

(43.2)

1,925

(64.5)

334

(33.6)

335

(34.6)

Fatigue, Grade 3c

31

(1.0)

191

(6.4)

8

(0.8)

8

(0.8)

Headache

938

(31.2)

1,622

(54.3)

306

(30.8)

275

(28.4)

Headache, Grade 3c

18

(0.6)

119

(4.0)

4

(0.4)

8

(0.8)

Myalgia

438

(14.6)

843

(28.2)

96

(9.7)

105

(10.8)

Myalgia, Grade 3c

11

(0.4)

71

(2.4)

1

(0.1)

1

(0.1)

Arthralgia

260

(8.7)

482

(16.1)

75

(7.6)

84

(8.7)

Arthralgia, Grade 3c

3

(<0.1)

25

(0.8)

1

(0.1)

0

(0)

Chills

309

(10.3)

904

(30.3)

67

(6.7)

74

(7.6)

Chills, Grade 3d

3

(<0.1)

19

(0.6)

0

(0)

0

(0)

Nausea/vomiting

325

(10.8)

716

(24.0)

107

(10.8)

97

(10.0)

Nausea/vomiting,

Grade 3b

5

(0.2)

19

(0.6)

0

(0)

0

(0)

Fever

≥38.0°C / >100.4°F

99

(3.3)

714

(23.9)

15

(1.5)

19

(2.0)

Fever,

Grade 3: 39.0° — 40.0°C / 102.1° — 104.0°F

17

(0.6)

115

(3.8)

2

(0.2)

2

(0.2)

Use of antipyretic or pain medication

730

(24.3)

1,423

(47.6)

95

(9.6)

93

(9.6)

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

An assessment of reactogenicity among participants with evidence of prior SARS-CoV-2 infection (immunologic or virologic evidence of prior SARS-CoV-2 infection [defined as positive RT-PCR test and/or positive Elecsys immunoassay result at Day 1]) compared to those with no evidence of infection at baseline (negative RT-PCR test and negative Elecsys immunoassay result at Day 1) was conducted. In ages 6 years through 11 years, 8.6% of participants (vaccine=257, placebo=87) had evidence of prior SARS-CoV-2 infection at baseline. Table 2 presents the number and percentage of the solicited local and systemic adverse reactions in Moderna COVID-19 Vaccine participants starting within 7 days after each dose by SARS-CoV-2 status.

Table 2: Number and Percentage of Participants 6 Years Through 11 Years Who Received Vaccine With Solicited Local and Systemic Adverse Reactions Starting Within 7 Days* After Each Dose by SARS-CoV-2 Status (Solicited Safety Set, Dose 1 and Dose 2)
Baseline SARS-CoV-2 Positive Baseline SARS-CoV-2 Negative
Dose 1 (N=257)n (%) Dose 2 (N= 255)n (%) Dose 1 (N=2,700)n (%) Dose 2 (N=2,686)n (%)
* 7 days included day of vaccination and the subsequent 6 days. Events were collected in the electronic diary (e-diary).
† No Grade 4 adverse reactions were reported.
a Grade 3 pain, axillary swelling/tenderness, nausea/vomiting: Defined as prevents daily activity.
b Grade 3 fatigue, headache, myalgia, arthralgia: Defined as significant; prevents daily activity.
c Grade 3 chills: Defined as prevents daily activity and requires medical intervention.

Local Adverse Reactions

Pain

234

(91.1)

240

(94.1)

2,522

(93.4)

2,547

(94.8)

Pain, Grade 3a

3

(1.2)

8

(3.1)

23

(0.9)

72

(2.7)

Axillary swelling/tenderness

63

(24.5)

48

(18.8)

394

(14.6)

474

(17.6)

Axillary swelling/tenderness, Grade 3a

1

(0.4)

0

(0)

2

(<0.1)

3

(0.1)

Swelling (hardness)

≥25 mm

29

(11.3)

29

(11.4)

317

(11.7)

468

(17.4)

Swelling (hardness), Grade 3: >100 mm

1

(0.4)

2

(0.8)

17

(0.6)

18

(0.7)

Erythema (redness)

≥25 mm

26

(10.1)

34

(13.3)

317

(11.7)

518

(19.3)

Erythema (redness), Grade 3: >100 mm

0

(0)

1

(0.4)

15

(0.6)

32

(1.2)

Systemic Adverse Reactions

Fatigue

129

(50.2)

145

(56.9)

1,145

(42.4)

1,744

(65.0)

Fatigue, Grade 3b

11

(4.3)

14

(5.5)

20

(0.7)

169

(6.3)

Headache

127

(49.4)

134

(52.5)

796

(29.5)

1,458

(54.3)

Headache, Grade 3b

8

(3.1)

11

(4.3)

10

(0.4)

103

(3.8)

Myalgia

63

(24.5)

75

(29.4)

367

(13.6)

747

(27.8)

Myalgia, Grade 3b

2

(0.8)

3

(1.2)

9

(0.3)

63

(2.3)

Arthralgia

33

(12.8)

43

(16.9)

224

(8.3)

427

(15.9)

Arthralgia, Grade 3b

0

(0)

1

(0.4)

3

(0.1)

22

(0.8)

Chills

51

(19.8)

68

(26.7)

251

(9.3)

815

(30.4)

Chills, Grade 3c

1

(0.4)

1

(0.4)

2

(<0.1)

17

(0.6)

Nausea/vomiting

36

(14.0)

54

(21.2)

281

(10.4)

646

(24.1)

Nausea/vomiting,

Grade 3a

1

(0.4)

0

(0)

4

(0.1)

18

(0.7)

Fever

≥38.0°C / >100.4°F

42

(16.3)

61

(23.9)

55

(2.0)

635

(23.6)

Fever,

Grade 3: 39.0° — 40.0°C / 102.1° — 104.0°F

5

(1.9)

6

(2.4)

12

(0.4)

108

(4.0)

Unsolicited Adverse Events

Participants were monitored for unsolicited adverse events for up to 28 days following each dose. Serious adverse events and medically attended adverse events will be recorded for the entire study duration. As of November 10, 2021, among participants who had received at least 1 dose of vaccine or placebo (vaccine=3,007, placebo=995), unsolicited adverse events that occurred within 28 days following each vaccination were reported by 29.6% of participants (n=891) who received Moderna COVID-19 Vaccine and 25.1% of participants (n=250) who received placebo. In these analyses, 98.6% of study participants had at least 28 days of follow-up after Dose 2.

During the 28-day follow-up period following any dose, lymphadenopathy-related events were reported by 1.8% of vaccine recipients and 0.6% of placebo recipients. These events included lymphadenopathy, lymph node pain, injection-site lymphadenopathy, and vaccination-site lymphadenopathy which were plausibly related to vaccination. This imbalance is consistent with the imbalance observed for solicited axillary swelling/tenderness in the injected arm.

During the 28-day follow-up period following any dose, hypersensitivity adverse events were reported in 4.3% of vaccine recipients and 2.1% of placebo recipients. Hypersensitivity events in the vaccine group included injection site rash and injection site urticaria, which are likely related to vaccination. Delayed injection site reactions that began >7 days after vaccination were reported in 2.7% of vaccine recipients and in 0.2% of placebo recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely related to vaccination.

During the 28-day follow-up period following any dose, events of abdominal pain (including abdominal pain, abdominal pain upper, and abdominal pain lower) were reported by 1.1% of vaccine recipients and 0.6% of placebo recipients. Currently available information 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 that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of November 10, 2021, serious adverse events were reported by 0.2% (n=6) of participants who received Moderna COVID-19 Vaccine and 0.2% (n=2) participants who received placebo. None of the events in the Moderna COVID-19 Vaccine group were considered related to vaccine. In these analyses, 98.6% of study participants had at least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was 51 days after Dose 2.

There were no notable patterns or imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Additional Safety Analyses

Participants 6 years through 11 years in Study 4 started to enter an open-label, observational phase after November 1, 2021. A long-term safety analysis was conducted in participants 6 years through 11 years from Study 4 who received Moderna COVID-19 Vaccine (n=3,007) with a cut-off date of February 21, 2022. In these analyses, the median duration of follow-up including both the blinded and open-label phases was 158 days after Dose 2. Through the cut-off date, there were no serious adverse events causally related to the vaccine.

Individuals 6 Months Through 5 Years of Age

Safety data for Moderna COVID-19 Vaccine from Study 4 included data in 6,388 participants 6 months through 5 years of age who received at least one dose of Moderna COVID-19 Vaccine (n=4,792) or placebo (n=1,596). As of the data cutoff date of February 21, 2022, the median duration of blinded follow-up for safety for participants 6 months through 23 months was 68 days after Dose 2. For participants 2 years to 5 years, the median duration of blinded follow-up for safety was 71 days after Dose 2.

For participants 6 months through 23 months, 51.1% were male, 48.9% were female, 13.2% were Hispanic or Latino, 79.0% were White, 3.1% were African American, 4.9% were Asian, 0.2% were American Indian or Alaska Native, 0.0% were Native Hawaiian or Pacific Islander, 1.5% were other races, and 10.6% were Multiracial. For participants 2 years through 5 years, 50.8% were male, 49.2% were female, 14.2% were Hispanic or Latino, 76.5% were White, 4.5% were African American, 6.0% were Asian, 0.4% were American Indian or Alaska Native, 0.3% were Native Hawaiian or Pacific Islander, 1.5% were other races, and 10.4% were Multiracial. Demographic characteristics were similar among participants who received Moderna COVID-19 Vaccine and those who received placebo.

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.

As of February 21, 2022, among participants 6 months through 23 months of age who had received at least 1 dose of vaccine or placebo (vaccine=1,761, placebo=589), unsolicited adverse events that occurred within 28 days following each vaccination were reported by 49.3% of participants (n=869) who received Moderna COVID-19 Vaccine and 48.2% of participants (n=284) who received placebo. In these analyses, 83.1% of study participants 6 months through 23 months of age had at least 28 days of follow-up after Dose 2. Among participants 2 years through 5 years of age who had received at least 1 dose of vaccine or placebo (vaccine=3,031, placebo=1,007), unsolicited adverse events that occurred within 28 days following each vaccination were reported by 40.0% of participants (n=1,212) who received Moderna COVID-19 Vaccine and 37.5% of participants (n=378) who received placebo. In these analyses, 89.3% of study participants 2 years through 5 years of age had at least 28 days of follow-up after Dose 2.

During the 28-day follow-up period following any dose, lymphadenopathy-related events were reported by 1.5% of vaccine recipients and 0.2% of placebo recipients who were 6 months through 23 months of age and 0.9% of vaccine recipients and <0.1% of placebo recipients who were 2 years through 5 years of age. These events included lymphadenopathy, injection-site lymphadenopathy, and vaccination-site lymphadenopathy which were plausibly related to vaccination.

During the 28-day follow-up period following any dose, hypersensitivity adverse events were reported in 3.9% of vaccine recipients and 5.3% of placebo recipients who were 6 months through 23 months of age and 3.5% of vaccine recipients and 2.5% of placebo recipients who were 2 years through 5 years of age. Hypersensitivity events in the vaccine group included injection site rash and injection site urticaria, which are likely related to vaccination. Delayed injection site reactions that began >7 days after vaccination were reported in 1.2% of vaccine recipients and no placebo recipients who were 6 months through 23 months of age and 1.4% of vaccine recipients and <0.1% of placebo recipients who were 2 years through 5 years of age. Delayed injection site reactions included pain, erythema, and swelling and are likely related to vaccination.

During the 28-day follow-up period following any dose, events of abdominal pain (including abdominal pain, abdominal pain upper, and abdominal discomfort) were reported by 0.7% of vaccine recipients and 0.4% of placebo recipients who were 2 years through 5 years of age. Currently available information 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 that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of February 21, 2022, serious adverse events were reported by 0.9% (n=15) of participants who received vaccine and 0.2% (n=1) of participants who received placebo who were 6 months through 23 months of age and 0.3% (n=9) of participants who received Moderna COVID-19 Vaccine and 0.2% (n=2) of participants who received placebo who were 2 years through 5 years of age. In these analyses, 83.1% of study participants 6 months through 23 months of age had at least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was 68 days after Dose 2. In these analyses, 89.3% of study participants 2 years through 5 years of age had at least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was 71 days after Dose 2.

In participants 6 months through 23 months of age who received the vaccine, a 1-year-old female experienced serious adverse events of a Grade 3 fever 6 hours after Dose 1 and a febrile convulsion 1 day after Dose 1. These events were considered related to vaccination. In participants 2 years through 5 years of age who received Moderna COVID-19 Vaccine, none of the events were considered related to vaccine.

Adolescents 12 Years Through 17 Years of Age

Safety data for Moderna COVID-19 Vaccine in adolescents were collected in an ongoing Phase 2/3 randomized, placebo-controlled, observer-blind, clinical trial conducted in the United States involving 3,726 participants 12 years through 17 years of age who received at least one dose of Moderna COVID-19 Vaccine (n=2,486) or placebo (n=1,240) (Study 3, NCT04649151). Overall, 51.4% were male, 48.6% were female, 11.6% were Hispanic or Latino, 83.9% were White, 3.4% were African American, 5.9% were Asian, 0.5% were American Indian or Alaska Native, <0.1% were Native Hawaiian or Pacific Islander, 1.0% were other races, and 4.5% were Multiracial. Demographic characteristics were similar among participants who received Moderna COVID-19 Vaccine and those who received placebo.

Unsolicited Adverse Events

Participants were monitored for unsolicited adverse events for up to 28 days following each dose. Serious adverse events and medically attended adverse events will be recorded for the entire study duration. As of May 8, 2021, among participants who had received at least 1 dose of vaccine or placebo (vaccine=2,486, placebo=1,240), unsolicited adverse events that occurred within 28 days following each vaccination were reported by 20.5% of participants (n=510) who received Moderna COVID-19 Vaccine and 15.9% of participants (n=197) who received placebo. In these analyses, 97.3% of study participants had at least 28 days of follow-up after Dose 2.

A 14-year-old male experienced probable myocarditis with onset of symptoms 1 day after Dose 2 of Moderna COVID-19 Vaccine. Symptoms resolved after 8 days and no sequelae were observed at 5 months. There were no cases of myocarditis among placebo recipients.

During the 28-day follow-up period following any dose, lymphadenopathy-related events that were not necessarily captured in the 7-day e-diary were reported by 5.0% of vaccine recipients and 0.5% of placebo recipients. These events included lymphadenopathy, vaccination-site lymphadenopathy and injection-site lymphadenopathy which were plausibly related to vaccination.

During the 28-day follow-up period following any dose, hypersensitivity adverse events were reported in 1.8% of vaccine recipients and 0.6% of placebo recipients. Hypersensitivity events in the vaccine group included injection site rash and injection site urticaria, which are likely related to vaccination. Delayed injection site reactions that began >7 days after vaccination were reported in 0.9% of vaccine recipients and in no placebo recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely related to vaccination.

There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of May 8, 2021, serious adverse events were reported by 0.2% (n=6) of participants who received Moderna COVID-19 Vaccine and 0.2% (n=2) of participants who received placebo. In these analyses, 97.3% of study participants had at least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was 53 days after Dose 2.

There were no notable patterns or imbalances between treatment groups for specific categories of serious adverse events that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Additional Safety Analyses

Study 3 participants started to enter an open-label, observational phase after May 10, 2021. A long-term safety analysis was conducted in participants from Study 3 who received Moderna COVID-19 Vaccine (n=2,486) with a cut-off date of January 31, 2022. In these analyses, the median duration of follow-up including both the blinded and open-label phases was 312 days after Dose 2 and 95.6% of study participants have had at least 6 months of follow-up after Dose 2. Through the cut-off date, there were no serious adverse events causally related to the vaccine.

Adults 18 Years of Age and Older

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 30,346 participants 18 years of age and older who received at least one dose of Moderna COVID-19 Vaccine (n=15,184) or placebo (n=15,162) (Study 1, NCT04470427). Upon issuance of the Emergency Use Authorization (December 18, 2020) for Moderna COVID-19 Vaccine, participants were unblinded in a phased manner over a period of months to offer placebo participants Moderna COVID-19 Vaccine. The median duration of follow up for safety after the second injection during the blinded phase was 4 months. The median duration of follow up for safety after the second injection including both the blinded phase and the open-label phase was 6 months.

In Study 1, the median age of the population was 52 years (range 18-95); 22,826 (75.2%) participants were 18 to 64 years of age and 7,520 (24.8%) participants were 65 years of age and older. Overall, 52.6% of the participants were male, 47.4% 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, 2.0% were other races, and 2.1% were Multiracial. Demographic characteristics were similar between participants who received Moderna COVID-19 Vaccine and those who received placebo.

Unsolicited Adverse Events

Participants were monitored for unsolicited adverse events for 28 days following each dose. Serious adverse events and medically attended adverse events will be recorded for the entire study duration (2 years). Among the 30,346 participants who had received at least 1 dose of vaccine (N=15,184) or placebo (N=15,162), unsolicited adverse events that occurred within 28 days following any vaccination were reported by 31.3% of participants (n=4,752) who received Moderna COVID-19 Vaccine and 28.6% of participants (n=4,338) who received placebo.

During the 28-day follow-up period following any dose, lymphadenopathy-related events were reported by 1.7% of vaccine recipients and 0.8% of placebo recipients. These events included lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy, injection-site lymphadenopathy, and axillary mass.

During the 7-day follow-up period of any vaccination, hypersensitivity events of injection site rash or injection site urticaria, likely related to vaccination, were reported by 6 participants in the Moderna COVID-19 Vaccine group and none in the placebo group. Delayed injection site reactions that began >7 days after vaccination were reported in 1.4% of vaccine recipients and 0.7% of placebo recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely related to vaccination.

In the blinded portion of the study, there were 8 reports of facial paralysis (including Bell’s palsy) in the Moderna COVID-19 Vaccine group, and 3 in the placebo group. In the 28-day follow-up period there were two cases of facial paralysis in the Moderna COVID-19 Vaccine group, which occurred on 8 and 22 days, respectively, after vaccination, and one in the placebo group, which occurred 17 days after vaccination. Currently available information on facial paralysis is insufficient to determine a causal relationship with the vaccine.

In the blinded portion of the study, there were 50 reports of herpes zoster in the Moderna COVID-19 Vaccine group, and 23 in the placebo group. In the 28-day period after any vaccination, there were 22 cases of herpes zoster in the Moderna COVID-19 Vaccine group, and 15 in the placebo group. Currently available information on herpes zoster infection 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

During the blinded phase of the study, serious adverse events were reported by 1.8% (n=268) of participants who received Moderna COVID-19 Vaccine and 1.9% (n=292) of participants who received placebo.

There were three serious adverse events of angioedema/facial swelling in the vaccine group in recipients with a history of injection of dermatological fillers. The onset of swelling was reported 1-2 days after the second dose 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.

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