Vaccine Information: Spikevax

SPIKEVAX- elasomeran injection, suspension
Moderna US, Inc.

1 INDICATIONS AND USAGE

SPIKEVAX is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

SPIKEVAX is supplied in two presentations:
o
multiple-dose vial containing 5.5 mL
o
multiple-dose vial containing 7.5 mL
SPIKEVAX multiple-dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.
Thaw each vial before use following the instructions below.

Multiple-Dose Vial Containing

Thaw in Refrigerator

Thaw at Room Temperature

5.5 mL

Thaw between 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes. Let each vial stand at room temperature for 15 minutes before administering.

Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 1 hour.

7.5 mL

Thaw between 2°C to 8°C (36°F to 46°F) for 3 hours. Let each vial stand at room temperature for 15 minutes before administering.

Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 1 hour and 30 minutes.

After thawing, do not refreeze.
Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
SPIKEVAX is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.
Each dose is 0.5 mL.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.
After the first dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Record the date and time of first use on the SPIKEVAX vial label. Discard vial after 12 hours. Do not refreeze.

2.2 Administration

Administer a single 0.5 mL dose.

2.3 Dosing and Schedule

SPIKEVAX is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of SPIKEVAX with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received one dose of SPIKEVAX should receive a second dose of SPIKEVAX to complete the vaccination series.

3 DOSAGE FORMS AND STRENGTHS

SPIKEVAX is a suspension for injection. A single dose is 0.5 mL.

4 CONTRAINDICATIONS

Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of SPIKEVAX.

5.2 Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

5.3 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines including SPIKEVAX. 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 immune response to SPIKEVAX.

5.5 Limitations of Vaccine Effectiveness

SPIKEVAX may not protect all vaccine recipients.

6 ADVERSE REACTIONS

In study participants 18 through 64 years of age, the most commonly reported (≥10%) adverse reactions following any dose were pain at injection site (93.3%), fatigue (71.9%), headache (68.7%), myalgia (64.8%), chills (49.7%), arthralgia (48.6%), nausea/vomiting (25.7%), axillary swelling/tenderness (22.2%), fever (17.3%), swelling at the injection site (15.4%), and erythema at the injection site (10.5%).

In study participants 65 years of age and older, the most commonly reported (≥10%) adverse reactions following any dose were pain at injection site (88.3%), fatigue (64.8%), headache (53.3%), myalgia (51.8%), arthralgia (40.2%), chills (32.7%), nausea/vomiting (15.0%), swelling at the injection site (13.0%), and axillary swelling/tenderness (12.7%).

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.

The safety of SPIKEVAX 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 SPIKEVAX (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 (SPIKEVAX), participants were unblinded in a phased manner over a period of months to offer placebo participants SPIKEVAX. 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 SPIKEVAX and those who received placebo.

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 SPIKEVAX (n=15,179) and participants receiving placebo (n=15,159) with at least 1 documented dose. Events that persisted for more than 7 days were followed until resolution. 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 are presented in Table 1 and Table 2, respectively.

Table 1: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Starting Within 7 Days* After Each Dose in Participants 18-64 Years (Solicited Safety Set, Dose 1 and Dose 2)
SPIKEVAX Placeboa
Dose 1
(N=11,406)
n (%)
Dose 2
(N=11,000)
n (%)
Dose 1
(N=11,402)
n (%)
Dose 2
(N=10,929)
n (%)

Local Adverse Reactions

Pain

9,908

(86.9)

9,893

(89.9)

2,183

(19.1)

2,048

(18.7)

Pain, Grade 3b

366

(3.2)

506

(4.6)

23

(0.2)

22

(0.2)

Axillary swelling/tenderness

1,322

(11.6)

1,777

(16.2)

567

(5.0)

474

(4.3)

Axillary swelling/tenderness, Grade 3b

37

(0.3)

47

(0.4)

13

(0.1)

12

(0.1)

Swelling (hardness)

≥25 mm

766

(6.7)

1,399

(12.7)

42

(0.4)

46

(0.4)

Swelling (hardness), Grade 3c

62

(0.5)

183

(1.7)

3

(<0.1)

5

(<0.1)

Erythema (redness)

≥25 mm

354

(3.1)

989

(9.0)

54

(0.5)

53

(0.5)

Erythema (redness), Grade 3c

34

(0.3)

210

(1.9)

11

(<0.1)

12

(0.1)

Systemic Adverse Reactions

Fatigue

4,385

(38.5)

7,453

(67.8)

3,281

(28.8)

2,701

(24.7)

Fatigue, Grade 3d

121

(1.1)

1,178

(10.7)

83

(0.7)

88

(0.8)

Fatigue, Grade 4e

1

(<0.1)

0

(0)

0

(0)

0

(0)

Headache

4,028

(35.3)

6,929

(63.0)

3,303

(29.0)

2,775

(25.4)

Headache, Grade 3f

220

(1.9)

559

(5.1)

163

(1.4)

132

(1.2)

Myalgia

2,700

(23.7)

6,789

(61.7)

1,625

(14.3)

1,425

(13.0)

Myalgia, Grade 3d

74

(0.6)

1,116

(10.1)

38

(0.3)

42

(0.4)

Arthralgia

1,892

(16.6)

5,010

(45.6)

1,327

(11.6)

1,180

(10.8)

Arthralgia, Grade 3d

47

(0.4)

650

(5.9)

30

(0.3)

37

(0.3)

Arthralgia, Grade 4e

1

(<0.1)

0

(0)

0

(0)

0

(0)

Chills

1,050

(9.2)

5,357

(48.7)

730

(6.4)

662

(6.1)

Chills, Grade 3g

17

(0.1)

164

(1.5)

8

(<0.1)

15

(0.1)

Nausea/vomiting

1,068

(9.4)

2,355

(21.4)

908

(8.0)

807

(7.4)

Nausea/vomiting,

Grade 3h

6

(<0.1)

11

(0.1)

8

(<0.1)

8

(<0.1)

Fever

102

(0.9)

1,909

(17.4)

37

(0.3)

38

(0.3)

Fever, Grade 3i

10

(<0.1)

185

(1.7)

1

(<0.1)

2

(<0.1)

Fever, Grade 4j

4

(<0.1)

12

(0.1)

4

(<0.1)

2

(<0.1)

Use of antipyretic or pain medication

2,656

(23.3)

6,307

(57.3)

1,523

(13.4)

1,254

(11.5)

* 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.

Table 2: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Starting Within 7 Days* After Each Dose in Participants 65 Years and Older (Solicited Safety Set, Dose 1 and Dose 2)
SPIKEVAX Placeboa
Dose 1
(N=3,760)
n (%)
Dose 2
(N=3,691)
n (%)
Dose 1
(N=3,749)
n (%)
Dose 2
(N=3,649)
n (%)

Local Adverse Reactions

Pain

2,780

(73.9)

3,071

(83.2)

482

(12.9)

438

(12.0)

Pain, Grade 3b

50

(1.3)

100

(2.7)

32

(0.9)

19

(0.5)

Axillary swelling/tenderness

231

(6.1)

315

(8.5)

155

(4.1)

97

(2.7)

Axillary swelling/tenderness, Grade 3b

12

(0.3)

21

(0.6)

14

(0.4)

8

(0.2)

Swelling (hardness)

≥25 mm

169

(4.5)

408

(11.1)

23

(0.6)

14

(0.4)

Swelling (hardness), Grade 3c

20

(0.5)

72

(2.0)

3

(<0.1)

7

(0.2)

Erythema (redness)

≥25 mm

91

(2.4)

285

(7.7)

23

(0.6)

15

(0.4)

Erythema (redness), Grade 3c

8

(0.2)

77

(2.1)

2

(<0.1)

3

(<0.1)

Systemic Adverse Reactions

Fatigue

1,251

(33.3)

2,154

(58.4)

852

(22.7)

717

(19.6)

Fatigue, Grade 3d

30

(0.8)

255

(6.9)

22

(0.6)

20

(0.5)

Headache

922

(24.5)

1,708

(46.3)

723

(19.3)

652

(17.9)

Headache, Grade 3e

53

(1.4)

107

(2.9)

34

(0.9)

33

(0.9)

Myalgia

742

(19.7)

1,740

(47.2)

444

(11.9)

399

(10.9)

Myalgia, Grade 3d

17

(0.5)

205

(5.6)

9

(0.2)

10

(0.3)

Arthralgia

618

(16.4)

1,293

(35.1)

457

(12.2)

399

(10.9)

Arthralgia, Grade 3d

13

(0.3)

125

(3.4)

8

(0.2)

7

(0.2)

Chills

201

(5.3)

1,143

(31.0)

148

(4.0)

151

(4.1)

Chills, Grade 3f

7

(0.2)

27

(0.7)

6

(0.2)

2

(<0.1)

Nausea/vomiting

194

(5.2)

439

(11.9)

167

(4.5)

134

(3.7)

Nausea/vomiting,

Grade 3g

4

(0.1)

10

(0.3)

5

(0.1)

3

(<0.1)

Nausea/vomiting,

Grade 4h

0

(0)

1

(<0.1)

0

(0)

0

(0)

Fever

10

(0.3)

367

(9.9)

7

(0.2)

5

(0.1)

Fever, Grade 3i

1

(<0.1)

18

(0.5)

1

(<0.1)

0

(0)

Fever, Grade 4j

0

(0)

1

(<0.1)

2

(<0.1)

1

(<0.1)

Use of antipyretic or pain medication

673

(17.9)

1,548

(41.9)

477

(12.7)

331

(9.1)

* 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.

Solicited local and systemic adverse reactions reported following administration of SPIKEVAX had a median duration of 1 to 3 days.

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

In Study 1, 2.3% of participants (vaccine=347, placebo=337) had evidence of prior SARS-CoV-2 infection at baseline (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]). Overall, among the 347 vaccine participants, there were no notable differences in reactogenicity compared to the 14,750 vaccine participants who had no evidence of prior SARS-CoV-2 infection at baseline (negative RT-PCR test and negative Elecsys immunoassay result at Day 1).

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 SPIKEVAX 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. This imbalance is consistent with the imbalance observed for solicited axillary swelling/tenderness at the injected arm.

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 SPIKEVAX 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 SPIKEVAX group, and 3 in the placebo group. In the 28-day follow-up period there were two cases of facial paralysis in the SPIKEVAX 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 SPIKEVAX group, and 23 in the placebo group. In the 28-day period after any vaccination, there were 22 cases of herpes zoster in the SPIKEVAX 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 SPIKEVAX.

Serious Adverse Events

During the blinded phase of the study, serious adverse events were reported by 1.8% (n=268) of participants who received SPIKEVAX 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 SPIKEVAX.

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