Safety Profile

Safety was evaluated in 6 studies in 5 different immunocompromised populations aged 18 years and older.1

Clinical Trial Program

The safety of SHINGRIX was evaluated in 6 placebo-controlled clinical studies that enrolled 3116 subjects aged 18 years and older from 5 different immunocompromised populations, including autologous hematopoietic stem cell transplant, hematologic malignancies, renal transplant, solid tumor malignancy, and HIV, in which a total of 1587 received SHINGRIX. In all studies, subjects received Doses 1 and 2 of SHINGRIX 1 to 2 months apart.1

Data from the largest of the 6 studies

Solicited Local and General Adverse Reactions Within 7 Days of Vaccination in Adult auHSCT Recipients Aged 18-49 Years1,*,†

	Adverse Reactions Dose 1		Adverse Reactions Dose 2
	All Grades/Grade 3‡,§		All Grades/Grade 3‡,§
	SHINGRIX %	Placebo\|\| %	SHINGRIX %	Placebo\|\| %
Local Adverse Reactions	n=223	n=217	n=205	n=207
Pain	81/11	8/1	82/11	6/0
Redness	20/1	0/0	25/2	0/0
Swelling	14/0	0/0	17/2	0/0
General Adverse Reactions	n=222	n=218	n=203	n=207
Myalgia	41/4	22/2	51/8	21/2
Fatigue	49/6	34/1	51/10	25/2
Headache	23/1	17/0	38/5	17/2
Shivering	20/1	12/0	26/6	6/0
Fever¶	9/0	4/0	28/1	2/0
GI#	14/1	13/0	13/1	12/1

Adverse Reactions Dose 1
Adverse Reactions Dose 2

	All Grades/Grade 3‡,§
	SHINGRIX %	Placebo\|\| %
Local Adverse Reactions	n=223	n=217
Pain	81/11	8/1
Redness	20/1	0/0
Swelling	14/0	0/0
General Adverse Reactions	n=222	n=218
Myalgia	41/4	22/2
Fatigue	49/6	34/1
Headache	23/1	17/0
Shivering	20/1	12/0
Fever¶	9/0	4/0
GI#	14/1	13/0

	All Grades/Grade 3‡,§
	SHINGRIX %	Placebo\|\| %
Local Adverse Reactions	n=205	n=207
Pain	82/11	6/0
Redness	25/2	0/0
Swelling	17/2	0/0
General Adverse Reactions	n=203	n=207
Myalgia	51/8	21/2
Fatigue	51/10	25/2
Headache	38/5	17/2
Shivering	26/6	6/0
Fever¶	28/1	2/0
GI#	13/1	12/1

Total vaccinated cohort (TVC) for safety included all subjects with at least 1 documented dose (n)
%=Percentage of subjects reporting the symptom at least once

*Seven days included day of vaccination and the subsequent 6 days.

†NCT01610414.¹

‡Grade 3 pain: defined as significant pain at rest preventing normal everyday activities; Grade 3 redness and swelling are defined as >100 mm in size.

§Grade 3 myalgia, fatigue, headache, shivering, and GI: defined as preventing normal activity.

||Placebo was sucrose reconstituted with saline solution.

¶Fever: defined as temperature ≥37.5°C (99.5°F). Grade 3 fever: defined as temperature >39.5°C (103.1°F).

#GI=gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

auHSCT=autologous hematopoietic stem cell transplant.

In general, the reported frequencies of solicited local and general adverse reactions in the other studies in immunocompromised populations were similar to that of the autologous hematopoietic stem cell transplant study.¹

Data from the largest of the 6 studies

Solicited Local and General Adverse Reactions Within 7 Days of Vaccination in Adult auHSCT Recipients ≥50 Years1,*,†

	Adverse Reactions Dose 1		Adverse Reactions Dose 2
	All Grades/Grade 3‡,§		All Grades/Grade 3‡,§
	SHINGRIX %	Placebo\|\| %	SHINGRIX %	Placebo\|\| %
Local Adverse Reactions	n=673	n=673	n=635	n=627
Pain	75/5	6/0.3	74/7	5/0
Redness	21/1	1/0	28/3	1/0
Swelling	10/0.1	1/0	15/1	1/0
General Adverse Reactions	n=674	n=674	n=633	n=628
Myalgia	37/2	18/1	43/4	17/1
Fatigue	37/3	31/2	46/4	26/3
Headache	15/0.1	13/0.4	25/2	8/1
Shivering	11/0.4	7/1	21/3	7/0.2
Fever¶	6/0.1	3/0	15/0.2	4/0.2
GI#	18/1	16/1	18/2	12/2

Adverse Reactions Dose 1
Adverse Reactions Dose 2

	All Grades/Grade 3‡,§
	SHINGRIX %	Placebo\|\| %
Local Adverse Reactions	n=673	n=673
Pain	75/5	6/0.3
Redness	21/1	1/0
Swelling	10/0.1	1/0
General Adverse Reactions	n=674	n=674
Myalgia	37/2	18/1
Fatigue	37/3	31/2
Headache	15/0.1	13/0.4
Shivering	11/0.4	7/1
Fever¶	6/0.1	3/0
GI#	18/1	16/1

	All Grades/Grade 3‡,§
	SHINGRIX %	Placebo\|\| %
Local Adverse Reactions	n=635	n=627
Pain	74/7	5/0
Redness	28/3	1/0
Swelling	15/1	1/0
General Adverse Reactions	n=633	n=628
Myalgia	43/4	17/1
Fatigue	46/4	26/3
Headache	25/2	8/1
Shivering	21/3	7/0.2
Fever¶	15/0.2	4/0.2
GI#	18/2	12/2

Total vaccinated cohort (TVC) for safety included all subjects with at least 1 documented dose (n)
%=Percentage of subjects reporting the symptom at least once

*Seven days included day of vaccination and the subsequent 6 days.

†NCT01610414.¹

‡Grade 3 pain: defined as significant pain at rest preventing normal everyday activities; Grade 3 redness and swelling are defined as >100 mm in size.

§Grade 3 myalgia, fatigue, headache, shivering, and GI: defined as preventing normal activity.

||Placebo was sucrose reconstituted with saline solution.

¶Fever: defined as temperature ≥37.5°C (99.5°F). Grade 3 fever: defined as temperature >39.5°C (103.1°F).

#GI=gastrointestinal symptoms including nausea, vomiting, diarrhea, and/or abdominal pain.

auHSCT=autologous hematopoietic stem cell transplant.

Additional Safety Information: Unsolicited Adverse Events, Serious Adverse Events, Deaths, and Potential Immune-Mediated Diseases Across 6 Trials of Immunocompromised Adults (TVC*)1

Within 30 days following each vaccination

SHINGRIX

Placebo

Unsolicited

AEs

(serious and nonserious)†

46%

44%

	From first administered dose up to 30 days post-last vaccination		From first administered dose up to 1 year post-last vaccination
	SHINGRIX	Placebo	SHINGRIX	Placebo
SAEs‡	7%	8%	26%	27%
Deaths§	0.1%	0.5%	6%	6%
pIMDs (new onset or exacerbation)\|\|			1.3%	1.0%

Within 30 days following each vaccination

SHINGRIX

Placebo

Unsolicited

AEs

(serious and nonserious)†

46%

44%

	From first administered dose up to 30 days post-last vaccination
	SHINGRIX	Placebo
SAEs‡	7%	8%
Deaths§	0.1%	0.5%

	From first administered dose up to 1 year post-last vaccination
	SHINGRIX	Placebo
SAEs‡	26%	27%
Deaths§	6%	6%
pIMDs (new onset or exacerbation)\|\|	1.3%	1.0%

*Total vaccinated cohort included all patients who received at least one dose of SHINGRIX or placebo.¹

†Adverse events of arthralgia, infective pneumonia, and influenza-like illness occurred in ≥1% of recipients of SHINGRIX and at a rate at least 1.5-fold higher than placebo (1.5% vs 1.0%, 1.5% vs 0.9%, and 1.3% vs 0.6%, respectively).¹

‡Serious adverse events of infective pneumonia were reported in 21 (1.3%) recipients of SHINGRIX and 11 (0.7%) recipients of placebo up to 30 days post-last vaccination. A causal relationship to vaccination cannot be determined.¹

§Causes of death among subjects were consistent with those expected in the populations evaluated.¹

||There were no notable imbalances in specific plMDs between treatment groups.¹

AEs=adverse events; plMDs=potential immune-mediated diseases; SAEs=serious adverse events.

Additional Safety Information: Other Medically Relevant Events (TVC*)1

Study	From first vaccination to study end
Study	Relapse/ progression, SHINGRIX n/N, %	Relapse/ progression, placebo n/N, %
auHSCT (Zoster 001)†	17/59 (29%)	8/30 (27%)
auHSCT (Zoster 002)‡	315/992 (34%)	331/924 (36%)
Hematologic malignancies	45/283 (16%)	58/279 (21%)
Renal transplant§	Confirmed allograft rejection, SHINGRIX n/N (%)	Confirmed allograft rejection, placebo n/N (%)
Renal transplant§	4/132 (3%)	7/132 (5%)
HIV	At least 1 event of worsening HIV, SHINGRIX n/N (%)	At least 1 event of worsening HIV, placebo n/N (%)
HIV	9/74 (12%)	5/49 (10%)

*Total vaccinated cohort included all patients who received at least one dose of SHINGRIX or placebo.¹

†NCT00920218.¹

‡NCT01610414.¹

§Creatinine as a measure of graft function and changes in alloimmunity post-vaccination were not systematically evaluated.¹

auHSCT=autologous hematopoietic stem cell transplant; HIV=human immunodeficiency virus; N=number of subjects in each group; n=number of subjects experiencing event; TVC=total vaccinated cohort.

You may also be interested in:

Reconstitution & Administration

See how you and your staff can reconstitute SHINGRIX in 4 steps.

Incidence of Shingles

Learn about the incidence of shingles in immunocompromised patients aged 18 years and older.

CDC Recommendations

See what CDC says about SHINGRIX.

Indication & Important Safety Info

Indication

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

in adults aged 50 years and older.
in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

in adults aged 50 years and older.
in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):

in adults aged 50 years and older.
in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.

SHINGRIX is not indicated for prevention of primary varicella infection (chickenpox).

Important Safety Information

SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX

SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX

SHINGRIX is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine or after a previous dose of SHINGRIX
Review immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of SHINGRIX
In a postmarketing observational study, an increased risk of Guillain-Barré syndrome was observed during the 42 days following vaccination with SHINGRIX
Syncope (fainting) can be associated with the administration of injectable vaccines, including SHINGRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
Solicited local adverse reactions reported in individuals aged 50 years and older were pain (78%), redness (38%), and swelling (26%)
Solicited general adverse reactions reported in individuals aged 50 years and older were myalgia (45%), fatigue (45%), headache (38%), shivering (27%), fever (21%), and gastrointestinal symptoms (17%)
Solicited local adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were pain (88% and 83%), redness (30% and 35%), and swelling (21% and 18%)
Solicited general adverse reactions reported in autologous hematopoietic stem cell transplant recipients (aged 18 to 49 and ≥50 years of age) were fatigue (64% and 54%), myalgia (58% and 52%), headache (44% and 30%), gastrointestinal symptoms (21% and 28%), shivering (31% and 25%), and fever (28% and 18%)
The data are insufficient to establish if there is vaccine-associated risk with SHINGRIX in pregnant women
It is not known whether SHINGRIX is excreted in human milk. Data are not available to assess the effects of SHINGRIX on the breastfed infant or on milk production/excretion
Vaccination with SHINGRIX may not result in protection of all vaccine recipients

Reference: 1. Prescribing Information for SHINGRIX.

You are encouraged to report vaccine adverse events to the US Department of Health and Human Services. Visit www.vaers.hhs.gov to file a report, or call 1-800-822-7967.

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